Chronic Kidney Disease and HypertensionPhase 3BaxDuo-PacificNCT06742723
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
A Phase 3 study testing Baxdrostat/dapagliflozin in people with Chronic Kidney Disease and Hypertension, run by AstraZeneca at 771 sites in 42 countries.
Trial summary
International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease and Hypertension
- What is being tested?
- Baxdrostat/dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,000 participants
- Where
- 771 sitesin 42 countries
- Study dates
- 3 Mar 2025to 18 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
- Participants with (a) or (b):
- eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:
- UACR ≥ 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratory value only), or
- UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
- UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only).
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- eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:
- UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
- UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)
- [obsolete]
- Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
- Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
- Participants with:
- Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values)
- Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values)
Who cannot join
- Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.
- Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
- Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
- 4. Participants with T1DM will be excluded, except:
- For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.
- For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
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- 5 Uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).
- 6 New York Heart Association functional HF class IV at screening.
- 7 Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.
- 8 Documented history of adrenal insufficiency.
- 9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
- 10 Any acute kidney injury within 3 months prior to the Screening Visit.
- 11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
- 12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).
Trial locations and contacts
771 sites in 42 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
771 sites in 42 countries
United States135 sites, 112 recruiting
- Recruiting
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Albany, New York, 12205
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Ann Arbor, Michigan, 48109
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Arlington, Texas, 76015
- Recruiting
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Arlington, Virginia, 22205
- Recruiting
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Arvada, Colorado, 80002
- Recruiting
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Atlanta, Georgia, 30328
- Withdrawn
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Augusta, Georgia, 30904
- Recruiting
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Austell, Georgia, 30106
- Recruiting
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Austin, Texas, 78726
- Recruiting
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Austin, Texas, 78735
- Suspended
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Austin, Texas, 78751
- Recruiting
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Bethesda, Maryland, 20889
- Recruiting
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Beverly Hills, California, 90211
- Recruiting
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Boca Raton, Florida, 33487
- Withdrawn
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Boston, Massachusetts, 02114
- Recruiting
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Boston, Massachusetts, 02115
- Recruiting
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Boynton Beach, Florida, 33435
- Recruiting
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Braintree, Massachusetts, 02184
- Recruiting
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Bridgeville, Pennsylvania, 15017
- Recruiting
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Brunswick, Georgia, 31520
- Recruiting
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Buffalo, New York, 14203
- Recruiting
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Burlington, Vermont, 05401
- Recruiting
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Butler, Pennsylvania, 16001
- Withdrawn
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Canoga Park, California, 91303
- Recruiting
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Canton, Ohio, 44718
- Recruiting
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Champaign, Illinois, 61822
- Recruiting
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Charleston, South Carolina, 29414
- Recruiting
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Chattanooga, Tennessee, 37421
- Recruiting
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Cincinnati, Ohio, 45212
- Recruiting
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Cincinnati, Ohio, 45219
- Recruiting
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Columbia, South Carolina, 29203
- Recruiting
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Columbus, Ohio, 43210
- Recruiting
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Columbus, Ohio, 43213
- Recruiting
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Columbus, Ohio, 43215
- Recruiting
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Concord, California, 94520
- Recruiting
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Conyers, Georgia, 30094
- Withdrawn
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Dallas, Texas, 75230
- Recruiting
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Dallas, Texas, 75234
- Recruiting
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Dallas, Texas, 75246
- Recruiting
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Decatur, Georgia, 30030
- Withdrawn
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Denver, Colorado, 80220
- Recruiting
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Detroit, Michigan, 48202
- Recruiting
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East Point, Georgia, 30344
- Recruiting
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East Providence, Rhode Island, 02914
- Recruiting
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East Providence, Rhode Island, 02915
- Recruiting
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Eatontown, New Jersey, 07724
- Recruiting
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Edgewater, Florida, 32132
- Withdrawn
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Evansville, Indiana, 47714
- Recruiting
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Exton, Pennsylvania, 19341
- Recruiting
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Fairhope, Alabama, 36532
- Recruiting
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Fort Lauderdale, Florida, 33316
- Recruiting
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Fremont, California, 94538
- Recruiting
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Fullerton, California, 92835
- Recruiting
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Garden City, Michigan, 48135
- Recruiting
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Greenville, North Carolina, 27834
- Suspended
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Greenville, North Carolina, 27834
- Suspended
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Hickory, North Carolina, 28601
- Recruiting
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Hollywood, Florida, 33021
- Completed
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Honolulu, Hawaii, 96814
- Recruiting
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Houston, Texas, 77004
- Recruiting
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Houston, Texas, 77099
- Recruiting
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Humble, Texas, 77346
- Recruiting
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Hutchinson, Kansas, 67502
- Recruiting
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Idaho Falls, Idaho, 83402
- Recruiting
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Indianapolis, Indiana, 46202
- Withdrawn
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Inglewood, California, 90301
- Recruiting
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Iowa City, Iowa, 52242
- Recruiting
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Jacksonville, North Carolina, 28546
- Recruiting
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Jacksonville Beach, Florida, 32250
- Recruiting
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Kansas City, Kansas, 66112
- Recruiting
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Kansas City, Missouri, 64112
- Recruiting
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Kansas City, Missouri, 64151
- Withdrawn
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Kenner, Louisiana, 70065
- Recruiting
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Kinston, North Carolina, 28504
- Recruiting
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Knoxville, Tennessee, 37912
- Suspended
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Knoxville, Tennessee, 37938
- Recruiting
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Lake City, Florida, 32055
- Recruiting
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Lakeland, Florida, 33805
- Recruiting
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Langhorne, Pennsylvania, 19047
- Withdrawn
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Las Vegas, Nevada, 89109
- Recruiting
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Lawrenceville, Georgia, 30046
- Completed
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Lewisville, Texas, 75057
- Recruiting
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Los Alamitos, California, 90720
- Recruiting
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Los Angeles, California, 90073
- Suspended
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Manassas, Virginia, 20110
- Recruiting
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Maywood, Illinois, 60153
- Recruiting
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Media, Pennsylvania, 19063
- Recruiting
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Melbourne, Florida, 32901
- Recruiting
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Metairie, Louisiana, 70006
- Suspended
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Miami Lakes, Florida, 33014
- Recruiting
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Morehead City, North Carolina, 28557
- Recruiting
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Nashville, Tennessee, 37232
- Recruiting
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New Bedford, Massachusetts, 02740
- Recruiting
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New Bern, North Carolina, 28562
- Recruiting
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New Britain, Connecticut, 06051
- Recruiting
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New York, New York, 10016
- Recruiting
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Newport News, Virginia, 23606
- Recruiting
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Norfolk, Nebraska, 68701
- Recruiting
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Ocoee, Florida, 34761
- Recruiting
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Orangeburg, South Carolina, 29118
- Recruiting
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Pasadena, Texas, 77504
- Suspended
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Pearland, Texas, 77584
- Recruiting
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Port Charlotte, Florida, 33952
- Completed
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Port Charlotte, Florida, 33952
- Recruiting
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Port Orange, Florida, 32127
- Completed
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Providence, Rhode Island, 02904
- Recruiting
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Raleigh, North Carolina, 27609
- Recruiting
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Richmond, Virginia, 23249
- Suspended
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Riverdale, Georgia, 30274
- Recruiting
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Riverview, Florida, 33578
- Recruiting
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Rockford, Illinois, 61107
- Recruiting
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Rocky Mount, North Carolina, 27804
- Recruiting
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Saint Joseph, Michigan, 49085
- Recruiting
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San Antonio, Texas, 78212
- Withdrawn
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San Diego, California, 92120
- Withdrawn
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San Francisco, California, 94110
- Recruiting
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Sanford, North Carolina, 27330
- Recruiting
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Seattle, Washington, 98195
- Recruiting
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South Salt Lake, Utah, 84115
- Recruiting
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Springfield, Oregon, 97477
- Recruiting
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St Louis, Missouri, 63136
- Recruiting
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Stanford, California, 94305
- Recruiting
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Statesville, North Carolina, 28625
- Recruiting
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Sun City, Arizona, 85351
- Recruiting
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Tarzana, California, 91356
- Recruiting
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Tucson, Arizona, 85741
- Recruiting
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Washington D.C., District of Columbia, 20037
- Recruiting
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West Des Moines, Iowa, 50266
- Recruiting
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West Monroe, Louisiana, 71291
- Recruiting
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Wichita, Kansas, 67214
- Recruiting
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Wilmington, North Carolina, 28401
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Wilmington, North Carolina, 28412
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Winston-Salem, North Carolina, 27103
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Woodbridge, Virginia, 22192
- Recruiting
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Worcester, Massachusetts, 01608
Japan63 sites, 60 recruiting
- Recruiting
Research Site
Aira, 899-5421
- Recruiting
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Amagasaki-shi, 660-8550
- Recruiting
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Beppu-shi, 874-0011
- Recruiting
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Chigasaki-shi, 253-0044
- Withdrawn
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Fujinomiya-shi, 418-0076
- Recruiting
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Hakodate-shi, 041-8680
- Recruiting
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Hamamatsu, 432-8580
- Recruiting
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Higashihiroshima-shi, 739-0041
- Recruiting
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Iizuka-shi, 820-8505
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Inashiki-gun, 300-0395
- Recruiting
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Iwata-shi, 438-8550
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Kagoshima, 890-0073
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Kamakura-shi, 247-0056
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Kanazawa, 920-8530
- Recruiting
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Kashiwara-shi, 582-0005
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Kasugai-shi, 486-8510
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Kita-ku, 144-0001
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Kitakyushu, 802-8555
- Recruiting
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Kitakyushu-shi, 807-0857
- Recruiting
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Kobe, 650-0017
- Withdrawn
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Kobe, 650-0047
- Recruiting
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Kumagaya-shi, 360-0197
- Recruiting
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Kurashiki Shi, 701 0192
- Recruiting
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Kuse-gun, 613-0034
- Recruiting
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Kuwana-shi, 511-0061
- Recruiting
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Kyoto, 604-8845
- Recruiting
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Kyoto, 612-8555
- Recruiting
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Matsusaka-shi, 515-8557
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Matsuyama, 790-0024
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Matsuyama, 790-8524
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Meguro-ku, 153-0051
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Minatoku, 105-8471
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Minatoku, 108-0073
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Minokamo Shi, 505-8510
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Miyakonojo-shi, 885-0035
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Morioka, 020-0066
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Nagaoka-shi, 940-8621
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Naka, 311-0113
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Narita-shi, 286-8520
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Obihiro-shi, 080-0848
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Ōita, 870-0039
- Recruiting
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Ōme, 198-0042
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Ōmihachiman, 523-0082
- Withdrawn
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Osaka, 534-0021
- Recruiting
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Osaka, 543-0035
- Recruiting
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Osaka, 553-0003
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Osaka, 558-8558
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Osaka, 559-0012
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Saga, 849-8501
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Sapporo, 003-0026
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Sapporo, 060-0061
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Sapporo, 062-0921
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Sendai, 980-8574
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Sendai, 981-3281
- Recruiting
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Shibuya-ku, 151-8528
- Recruiting
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tabashi City, 173-0015
- Recruiting
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Tanabe-shi, 646-8558
- Recruiting
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Toyoake-shi, 470-1192
- Recruiting
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Toyohashi, 441-8570
- Recruiting
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Tsu, 514-8507
- Recruiting
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Yaizu-shi, 425-8505
- Recruiting
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Yokohama, 236-0004
- Recruiting
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Yoshida-gun, 910-1193
China62 sites, 60 recruiting
- Recruiting
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Baotou, 014010
- Recruiting
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Beijing, 100034
- Withdrawn
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Beijing, 100068
- Recruiting
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Beijing, CN-100083
- Recruiting
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Changchun, 130041
- Recruiting
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Changsha, 410008
- Recruiting
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Changsha, 410015
- Recruiting
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Changzhou, 272100
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Chengdu, 610000
- Recruiting
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Chengdu, 610072
- Recruiting
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Chongqing, 400010
- Recruiting
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Dongwan, 523058
- Not yet recruiting
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Fuyang, 236012
- Recruiting
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Guangzhou, 510280
- Recruiting
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Guangzhou, 510665
- Recruiting
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Guangzhou, 510800
- Recruiting
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Guangzhou, 511486
- Recruiting
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Haikou, 570311
- Recruiting
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Hefei, 230061
- Recruiting
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Hefei, 230601
- Recruiting
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Hengyang, 421001
- Recruiting
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Heze, 274099
- Recruiting
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Huaian, 223399
- Recruiting
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Jiaxing, 314001
- Recruiting
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Jilin City, 132011
- Recruiting
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Jinan, 250021
- Recruiting
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Jinhua, 321000
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Jining, 272006
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Lanzhou, 730000
- Recruiting
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Linhai, 317000
- Recruiting
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Linyi, 276003
- Recruiting
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Luoyang, 471003
- Recruiting
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Nanchang, 330006
- Recruiting
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Nanning
- Recruiting
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Ningbo, 315010
- Recruiting
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Ningbo, 315099
- Recruiting
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Ningbo, 315800
- Recruiting
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Panjin, 124009
- Recruiting
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Pingxiang, 337055
- Recruiting
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Shanghai, 200061
- Recruiting
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Shanghai, 200080
- Recruiting
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Shanghai, 201199
- Recruiting
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Shantou, 515041
- Recruiting
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Shenyang, 110004
- Recruiting
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Shenzhen, 518036
- Recruiting
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Shenzhen, 518053
- Recruiting
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Suzhou, 215004
- Recruiting
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Taian, 271099
- Not yet recruiting
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Tianjin, 300192
- Recruiting
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Tianjin, CN-300052
- Recruiting
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Wanzhou, 404000
- Recruiting
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Wuhan, 430000
- Recruiting
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Wuhan, 430010
- Recruiting
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Wuxi, 214023
- Recruiting
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Xi'an, 710061
- Withdrawn
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Xianyang, 750004
- Recruiting
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Yantai, 264000
- Recruiting
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Yinchuan, 750004
- Recruiting
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Zhengzhou, 450000
- Recruiting
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Zhongshan, 528401
- Recruiting
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Zhuzhou, 412007
- Recruiting
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Zigong, 643000
Poland36 sites, 32 recruiting
- Recruiting
Research Site
Bialystok, 15-540
- Recruiting
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Gdynia, 81-157
- Recruiting
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Gdynia, 81-519
- Recruiting
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Gmina Świecie, 86-100
- Active, not recruiting
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Jasło, 38-200
- Recruiting
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Katowice, 40-600
- Recruiting
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Katowice, 40-648
- Recruiting
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Katowice, 40-772
- Recruiting
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Krakow, 30-688
- Recruiting
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Krakow, 31-261
- Recruiting
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Krakow, 31-501
- Recruiting
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Krakow, 31-513
- Recruiting
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Lodz, 91-363
- Recruiting
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Lodz, 92-213
- Recruiting
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Lublin, 20-718
- Withdrawn
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Piaseczno, 05-500
- Recruiting
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Poznan, 60-309
- Recruiting
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Poznan, 60-354
- Recruiting
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Poznan, 61-848
- Recruiting
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Pruszków, 05-800
- Recruiting
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Radom, 26-600
- Recruiting
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Rzeszów, 35-055
- Recruiting
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Szczecin, 70-111
- Recruiting
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Szczecin, 71-434
- Recruiting
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Szczecin, 71-526
- Recruiting
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Tczew, 83-110
- Recruiting
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Warsaw, 00-124
- Recruiting
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Warsaw, 00-719
- Recruiting
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Warsaw, 02-097
- Recruiting
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Warsaw, 02-507
- Active, not recruiting
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Warsaw, 02-595
- Active, not recruiting
Research Site
Warsaw, 02-798
- Recruiting
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Warsaw, 03-291
- Recruiting
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Wroclaw, 50-304
- Recruiting
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Wroclaw, 53-673
- Recruiting
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Żywiec, 34-300
Germany35 sites, 26 recruiting
- Recruiting
Research Site
Bad Homburg, 61348
- Recruiting
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Bamberg, 96049
- Recruiting
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Berlin, 10117
- Recruiting
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Berlin, 10629
- Recruiting
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Berlin, 13509
- Recruiting
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Bochum, 44787
- Recruiting
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Brandenburg an der Havel, 14770
- Recruiting
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Brandenburg an der Havel, 14776
- Recruiting
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Dresden, 01279
- Recruiting
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Essen, 45122
- Withdrawn
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Friedrichsthal, 66299
- Recruiting
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Görlitz, 02828
- Recruiting
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Göttingen, 37075
- Withdrawn
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Hamburg, 21109
- Recruiting
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Hanover, 30449
- Recruiting
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Hanover, 30459
- Recruiting
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Hanover, 30625
- Withdrawn
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Heidelberg, 69115
- Recruiting
Research Site
Heidelberg, 69120
- Recruiting
Research Site
Herne, 44625
- Withdrawn
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Karlsburg, 17495
- Recruiting
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Karlsruhe, 76133
- Withdrawn
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Karlsruhe, 76137
- Recruiting
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Landshut, 84034
- Recruiting
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Mainz, 55131
- Recruiting
Research Site
Obertshausen, 63179
- Recruiting
Research Site
Offenbach, 63065
- Withdrawn
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Potsdam, 14473
- Active, not recruiting
Research Site
Reinfeld (Holstein), 23858
- Withdrawn
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Rostock, 18057
- Recruiting
Research Site
Rotenburg (Wümme), 27356
- Withdrawn
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Stuttgart, 70376
- Recruiting
Research Site
Ulm, 89081
- Recruiting
Research Site
Wermsdorf, 04779
- Recruiting
Research Site
Zwenkau, 04442
France25 sites, 25 recruiting
- Recruiting
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Amiens, 80054
- Recruiting
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Bordeaux, 33076
- Recruiting
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Boulogne-Billancourt, 92104
- Recruiting
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Brest, 29200
- Recruiting
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Clermont-Ferrand, 63003
- Recruiting
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Créteil, 94000
- Recruiting
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La Roche-sur-Yon, 85925
- Recruiting
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Le Mans, 72037
- Recruiting
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Limoges, 87042
- Recruiting
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Lyon, 69437
- Recruiting
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Marseille, 13005
- Recruiting
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Nantes, 44093
- Recruiting
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Nice, 06000
- Recruiting
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Nîmes, 30000
- Recruiting
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Paris, 75015
- Recruiting
Research Site
Paris, 75018
- Recruiting
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Pierre-Bénite, 69495
- Recruiting
Research Site
Poitiers, 86021
- Recruiting
Research Site
Quimper, 29000
- Recruiting
Research Site
Reims, 51100
- Recruiting
Research Site
Rouen, 76031
- Recruiting
Research Site
Saint-Priest-en-Jarez, 42270
- Recruiting
Research Site
Strasbourg, 67098
- Recruiting
Research Site
Tours, 37044
- Recruiting
Research Site
Vandœuvre-lès-Nancy, 54511
Argentina22 sites, 18 recruiting
- Recruiting
Research Site
Buenos Aires, C1060AAB
- Withdrawn
Research Site
CABA, C1426
- Recruiting
Research Site
CABA, C1426
- Recruiting
Research Site
Ciudad Autonoma de Bs As, C1023AAB
- Recruiting
Research Site
Ciudad de Buenos Aires, C1425AGC
- Withdrawn
Research Site
Córdoba, 5000
- Active, not recruiting
Research Site
Córdoba, 5000
- Recruiting
Research Site
Córdoba, X5002HWE
- Recruiting
Research Site
Córdoba, X5003DCE
- Recruiting
Research Site
Córdoba, X5006CBI
- Recruiting
Research Site
Córdoba, X5016LIG
- Recruiting
Research Site
La Plata, B1900AVG
- Recruiting
Research Site
Lanus, 1824
- Recruiting
Research Site
Lanús Este, B1824KAJ
- Recruiting
Research Site
Mar del Plata, 7600
- Recruiting
Research Site
Mar del Plata, B7600
- Recruiting
Research Site
Rosario, 2000
- Recruiting
Research Site
San Nicolás, B2900DMH
- Recruiting
Research Site
Santa Fe, S3000FWO
- Recruiting
Research Site
Santiago del Estero, 4200
- Withdrawn
Research Site
Temperley, 1834
- Recruiting
Research Site
Temperley, CP1834
Canada21 sites, 19 recruiting
- Recruiting
Research Site
Edmonton, Alberta, T6G 2P4
- Recruiting
Research Site
Etobicoke, Ontario, M9W 6V1
- Recruiting
Research Site
Halifax, Nova Scotia, B3H 1V7
- Recruiting
Research Site
Laval, Quebec, H7T 2P5
- Recruiting
Research Site
London, Ontario, N6A 5A5
- Recruiting
Research Site
Montreal, Quebec, H1T 2M4
- Recruiting
Research Site
Montreal, Quebec, H2X 0A9
- Recruiting
Research Site
Montreal, Quebec, H4J 1C5
- Recruiting
Research Site
Montreal, Quebec, H4J 1E3
- Withdrawn
Research Site
Oshawa, Ontario, L1G 2B9
- Recruiting
Research Site
Québec, Quebec, G1R 2J6
- Recruiting
Research Site
Saint John, New Brunswick, E2L 4L2
- Recruiting
Research Site
Sarnia, Ontario, N7T 4X3
- Recruiting
Research Site
Surrey, British Columbia, V3T 0H1
- Recruiting
Research Site
Toronto, Ontario, M3M 0B2
- Recruiting
Research Site
Toronto, Ontario, M4G 3E8
- Recruiting
Research Site
Toronto, Ontario, M5G 2N2
- Recruiting
Research Site
Toronto, Ontario, M9V 4B4
- Withdrawn
Research Site
Vancouver, British Columbia, V6Z 1Y6
- Recruiting
Research Site
Waterloo, Ontario, N2T 0C1
- Recruiting
Research Site
Winnipeg, Manitoba, R2V 3M3
Bulgaria20 sites, 16 recruiting
- Recruiting
Research Site
Byala, 7100
- Recruiting
Research Site
Dupnitsa, 2600
- Recruiting
Research Site
Gabrovo, 5300
- Recruiting
Research Site
Gotse Delchev, 2900
- Terminated
Research Site
Kozloduy, 3320
- Terminated
Research Site
Lom, 3600
- Recruiting
Research Site
Pernik, 2300
- Recruiting
Research Site
Plovdiv, 4004
- Recruiting
Research Site
Rousse, 7013
- Recruiting
Research Site
Sandanski, 2800
- Recruiting
Research Site
Sevlievo, 5403
- Active, not recruiting
Research Site
Sliven, 8800
- Recruiting
Research Site
Sofia, 1000
- Recruiting
Research Site
Sofia, 1431
- Recruiting
Research Site
Sofia, 1680
- Recruiting
Research Site
Sofia
- Recruiting
Research Site
Varna, 9000
- Recruiting
Research Site
Varna, 9010
- Recruiting
Research Site
Veliko Tarnovo, 5000
- Withdrawn
Research Site
Yambol, 8600
Ukraine19 sites, 17 recruiting
- Recruiting
Research Site
Chernivtsі, 58002
- Recruiting
Research Site
Ivano-Frankivsk, 76008
- Recruiting
Research Site
Kyiv, 01601
- Recruiting
Research Site
Kyiv, 02002
- Recruiting
Research Site
Kyiv, 03037
- Recruiting
Research Site
Kyiv, 03049
- Recruiting
Research Site
Kyiv, 03057
- Recruiting
Research Site
Kyiv, 04050
- Recruiting
Research Site
Kyiv, 04210
- Recruiting
Research Site
Lviv, 79016
- Recruiting
Research Site
Ternopil, 46000
- Recruiting
Research Site
Ternopil, 46001
- Completed
Research Site
Uzhhorod, 88014
- Recruiting
Research Site
Uzhhorod, 88018
- Recruiting
Research Site
Vinnytsia, 21001
- Recruiting
Research Site
Vinnytsia, 21009
- Not yet recruiting
Research Site
Vinnytsia, 21018
- Recruiting
Research Site
Vinnytsia, 21029
- Terminated
Research Site
Zhytomyr, 10002
Brazil17 sites, 17 recruiting
- Recruiting
Research Site
Barretos, 14784-400
- Recruiting
Research Site
Belém, 66073-005
- Recruiting
Research Site
Brasília, 70200-730
- Recruiting
Research Site
Campina Grande do Sul, 83.430-000
- Recruiting
Research Site
Campinas, 13060-080
- Recruiting
Research Site
Campinas, 13060-803
- Recruiting
Research Site
Curitiba, 80230-130
- Recruiting
Research Site
Fortaleza, 60175-047
- Recruiting
Research Site
Joinville, 89227-680
- Recruiting
Research Site
Natal, 59020-500
- Recruiting
Research Site
Porto Alegre, 90020-090
- Recruiting
Research Site
Porto Alegre, 90160-093
- Recruiting
Research Site
Rio de Janeiro, 20241-180
- Recruiting
Research Site
São José do Rio Preto, 15090-000
- Recruiting
Research Site
São Paulo, 04012-180
- Recruiting
Research Site
São Paulo, 04038-031
- Recruiting
Research Site
São Paulo, 05403-000
Italy16 sites, 16 recruiting
- Recruiting
Research Site
Bassano del Grappa, 36031
- Recruiting
Research Site
Bologna, 40138
- Recruiting
Research Site
Desio, 20832
- Recruiting
Research Site
Foggia, 71100
- Recruiting
Research Site
Genoa, 16132
- Recruiting
Research Site
Modena, 41124
- Recruiting
Research Site
Naples, 80138
- Recruiting
Research Site
Novara, 28100
- Recruiting
Research Site
Padova, 35128
- Recruiting
Research Site
Pavia, 27100
- Recruiting
Research Site
Pisa, 56124
- Recruiting
Research Site
Pordenone, 33170
- Recruiting
Research Site
Roma, 00168
- Recruiting
Research Site
Rozzano, 20089
- Recruiting
Research Site
Torino, 10126
- Recruiting
Research Site
Tradate, 21049
Hungary15 sites, 11 recruiting
- Recruiting
Research Site
Budapest, 1036
- Recruiting
Research Site
Budapest, 1085
- Recruiting
Research Site
Budapest, 1132
- Recruiting
Research Site
Budapest, 1138
- Recruiting
Research Site
Dunaújváros, 2400
- Withdrawn
Research Site
Encs, 3860
- Recruiting
Research Site
Győr, 9024
- Recruiting
Research Site
Kaposvár, 7400
- Recruiting
Research Site
Nyíregyháza, 4400
- Withdrawn
Research Site
Nyíregyháza, 4405
- Withdrawn
Research Site
Szeged, 6724
- Recruiting
Research Site
Szeged, 6725
- Recruiting
Research Site
Székesfehérvár, 8000
- Withdrawn
Research Site
Szolnok, 5004
- Recruiting
Research Site
Zalaegerszeg, 8900
South Africa15 sites, 11 recruiting
- Recruiting
Research Site
Bellville, 7530
- Recruiting
Research Site
Benoni, 1501
- Withdrawn
Research Site
Bloemfontein, 9301
- Recruiting
Research Site
Bloemfontein, 9301
- Recruiting
Research Site
Cape Town, 7570
- Recruiting
Research Site
Cape Town, 7925
- Recruiting
Research Site
Durban, 4091
- Withdrawn
Research Site
Durban, 4092
- Withdrawn
Research Site
Durban, 4450
- Recruiting
Research Site
Johannesburg, 1827
- Recruiting
Research Site
KwaDukuza, 4449
- Recruiting
Research Site
Lenasia, 1827
- Recruiting
Research Site
Midrand, 1685
- Recruiting
Research Site
Newton, 2113
- Withdrawn
Research Site
Parow, 7505
Belgium14 sites, 13 recruiting
- Recruiting
Research Site
Aalst, 9300
- Recruiting
Research Site
Brussels, 1200
- Recruiting
Research Site
Genk, 3600
- Recruiting
Research Site
Hasselt, 3500
- Recruiting
Research Site
Ieper, 8900
- Recruiting
Research Site
Jette, 1090
- Recruiting
Research Site
Kortrijk, 8500
- Recruiting
Research Site
Leuven, 3000
- Recruiting
Research Site
Liège, 4000
- Recruiting
Research Site
Mechelen, 2800
- Recruiting
Research Site
Namur, 5000
- Recruiting
Research Site
Roeselare, 8800
- Recruiting
Research Site
Ronse, 9600
- Withdrawn
Research Site
Sint-Truiden, 3800
India14 sites, 12 recruiting
- Withdrawn
Research Site
Bangalore, 560060
- Recruiting
Research Site
Belagavi, 590010
- Withdrawn
Research Site
Hyderabad, 500 034
- Recruiting
Research Site
Hyderabad, 500082
- Recruiting
Research Site
Kolkata, 700014
- Recruiting
Research Site
Kolkata, 700020
- Recruiting
Research Site
Madurai, 625107
- Recruiting
Research Site
Mumbai, 400026
- Recruiting
Research Site
New Delhi, 110001
- Recruiting
Research Site
New Delhi, 110017
- Recruiting
Research Site
New Delhi, 110029
- Recruiting
Research Site
Pune, 411013
- Recruiting
Research Site
Vijayawada, 520 008
- Recruiting
Research Site
Vijayawada, 522002
Peru13 sites, 10 recruiting
- Suspended
Research Site
Arequipa, AREQUIPA01
- Recruiting
Research Site
Bellavista, CALLAO 2
- Recruiting
Research Site
Chorrillos, Lima 9
- Not yet recruiting
Research Site
Cusco, CUSCO 01
- Recruiting
Research Site
Lima, 14
- Recruiting
Research Site
Lima, 15036
- Recruiting
Research Site
Lima, 15046
- Withdrawn
Research Site
Lima, 15046
- Not yet recruiting
Research Site
Lima, 15072
- Withdrawn
Research Site
Lima, 15074
- Recruiting
Research Site
Lima, 15088
- Recruiting
Research Site
Lima, LIMA 01
- Recruiting
Research Site
Piura, 20001
Czechia12 sites, 7 recruiting
- Withdrawn
Research Site
Brandýs nad Labem, 250 01
- Withdrawn
Research Site
Frýdek-Místek, 738 01
- Recruiting
Research Site
Jilemnice, 514 01
- Completed
Research Site
Krnov, 794 01
- Recruiting
Research Site
Mladá Boleslav, 293 01
- Recruiting
Research Site
Náchod, 547 01
- Withdrawn
Research Site
Olomouc, 772 00
- Recruiting
Research Site
Pilsen, 323 00
- Recruiting
Research Site
Prague, 104 00
- Recruiting
Research Site
Prague, 140 00
- Suspended
Research Site
Prague, 160 00
- Recruiting
Research Site
Slaný, 274 01
Israel12 sites, 11 recruiting
- Recruiting
Research Site
Afula, 18101
- Recruiting
Research Site
Ashdod, 7747629
- Recruiting
Research Site
Be’er Ya‘aqov, 70300
- Recruiting
Research Site
Haifa, 3109601
- Recruiting
Research Site
Haifa, 34362
- Withdrawn
Research Site
Jerusalem, 91120
- Recruiting
Research Site
Kfar Saba, 44281
- Recruiting
Research Site
Nahariya, 22100
- Recruiting
Research Site
Petah Tikva, 49372
- Recruiting
Research Site
Rehovot, 76100
- Recruiting
Research Site
Tel Aviv, 6423906
- Recruiting
Research Site
Tiberias, 15208
Mexico12 sites, 12 recruiting
- Recruiting
Research Site
Chihuahua City, 31000
- Recruiting
Research Site
Cuauhtémoc, 06700
- Recruiting
Research Site
D.F, 14000
- Recruiting
Research Site
Durango, 34000
- Recruiting
Research Site
Guadalajara, 44670
- Recruiting
Research Site
Guadalajara, 44690
- Recruiting
Research Site
Mazatlán, 82000
- Recruiting
Research Site
Mazatlán, 82110
- Recruiting
Research Site
Mérida, 97130
- Recruiting
Research Site
San Luis Potosí City, 78250
- Recruiting
Research Site
Veracruz, 91855
- Recruiting
Research Site
Zapopan, 45138
South Korea12 sites, 12 recruiting
- Recruiting
Research Site
Ansan-si, 15355
- Recruiting
Research Site
Anyang-si, 14068
- Recruiting
Research Site
Busan, 49241
- Recruiting
Research Site
Cheonan-si, 31151
- Recruiting
Research Site
Goyang-si, 10380
- Recruiting
Research Site
Gwangju, 61469
- Recruiting
Research Site
Seongnam-si, 13620
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 04401
- Recruiting
Research Site
Seoul, 07061
- Recruiting
Research Site
Wŏnju, 26426
- Recruiting
Research Site
Yangsan, 50612
Spain12 sites, 11 recruiting
- Recruiting
Research Site
A Coruña, 15006
- Recruiting
Research Site
Almería, 4009
- Recruiting
Research Site
Badalona, 08916
- Recruiting
Research Site
L'Hospitalet de Llobregat, 08907
- Recruiting
Research Site
Majadahonda, 28222
- Recruiting
Research Site
Málaga, 29010
- Suspended
Research Site
Palma deMallorca, 07010
- Recruiting
Research Site
Pamplona, 31008
- Recruiting
Research Site
Seville, 41013
- Recruiting
Research Site
Seville, 41071
- Recruiting
Research Site
Valencia, 46010
- Recruiting
Research Site
Valencia, 46017
United Kingdom12 sites, 12 recruiting
- Recruiting
Research Site
Bradford, BND9 6RJ
- Recruiting
Research Site
Bristol, BS105NB
- Recruiting
Research Site
Canterbury, CT1 3NG
- Recruiting
Research Site
Cardiff, CF14 4XW
- Recruiting
Research Site
Dundee, DD1 9SY
- Recruiting
Research Site
Glasgow, G51 4TF
- Recruiting
Research Site
Hounslow, TW3 3LN
- Recruiting
Research Site
London, E1 1FR
- Recruiting
Research Site
London, N16 6UH
- Recruiting
Research Site
London, SE5 9RS
- Recruiting
Research Site
Salford, M6 8HD
- Recruiting
Research Site
Swansea, SN6 6NL
Philippines11 sites, 8 recruiting
- Recruiting
Research Site
Cebu City, 6000
- Recruiting
Research Site
Davao City, 8000
- Recruiting
Research Site
Davao City, PH-8000
- Not yet recruiting
Research Site
Davao City, PH-8000
- Recruiting
Research Site
Iloilo City, 5000
- Recruiting
Research Site
Laguna, 4024
- Recruiting
Research Site
Manadaluyong City, 1552
- Withdrawn
Research Site
Manila, 1000
- Recruiting
Research Site
Quezon City, 1101
- Withdrawn
Research Site
Quezon City
- Withdrawn
Research Site
San Fernando City, 2000
Romania11 sites, 8 recruiting
- Withdrawn
Research Site
Brasov, 500073
- Recruiting
Research Site
Bucharest, 042122
- Recruiting
Research Site
Bucharest, 060044
- Withdrawn
Research Site
Bucharest, 22325
- Recruiting
Research Site
Bucharest, 22328
- Recruiting
Research Site
Cluj-Napoca, 400349
- Recruiting
Research Site
Craiova, 200349
- Recruiting
Research Site
Craiova, 200642
- Recruiting
Research Site
Oradea, 410469
- Terminated
Research Site
Suceava, 720237
- Recruiting
Research Site
Timișoara, 300723
Colombia10 sites, 10 recruiting
- Recruiting
Research Site
Barranquilla, 080020
- Not yet recruiting
Research Site
Barranquilla, 080020
- Recruiting
Research Site
Barranquilla, 80007
- Recruiting
Research Site
Bogotá, 111411
- Recruiting
Research Site
Cali, 760042
- Not yet recruiting
Research Site
Manizales, 170004
- Recruiting
Research Site
Medellín, 050030
- Recruiting
Research Site
Medellín, 050034
- Recruiting
Research Site
Montería, 230002
- Recruiting
Research Site
Pasto, 520002
Serbia10 sites, 6 recruiting
- Recruiting
Research Site
Belgrade, 11000
- Withdrawn
Research Site
Belgrade, 11000
- Recruiting
Research Site
Belgrade, 11070
- Withdrawn
Research Site
Belgrade, 11120
- Recruiting
Research Site
Kamenitz, 21204
- Recruiting
Research Site
Kragujevac, 34000
- Withdrawn
Research Site
Kragujevac, 34000
- Recruiting
Research Site
Niš, 18000
- Withdrawn
Research Site
Novi Sad, 21000
- Recruiting
Research Site
Novi Sad, 21000
Slovakia10 sites, 8 recruiting
- Recruiting
Research Site
Košice, 040 01
- Withdrawn
Research Site
Kráľovský Chlmec, 077 01
- Recruiting
Research Site
Myjava, 90701
- Recruiting
Research Site
Nitra, 949 11
- Recruiting
Research Site
Prešov, 080 01
- Withdrawn
Research Site
Prešov, 080 01
- Recruiting
Research Site
Púchov, 020 01
- Recruiting
Research Site
Trenčín, 91171
- Recruiting
Research Site
Trnava, 917 02
- Recruiting
Research Site
Žilina, 010 01
Turkey (Türkiye)10 sites, 10 recruiting
- Recruiting
Research Site
Adana, 01060
- Recruiting
Research Site
Adapazarı, 54100
- Recruiting
Research Site
Altındağ, 06230
- Recruiting
Research Site
Ankara, 06530
- Recruiting
Research Site
Antalya, 07100
- Recruiting
Research Site
Haliliye, 63040
- Recruiting
Research Site
Kahramanmaraş, 46040
- Recruiting
Research Site
Kayseri, 38039
- Recruiting
Research Site
Kocaeli, 41380
- Recruiting
Research Site
Şahinbey, 27310
Australia9 sites, 8 recruiting
- Recruiting
Research Site
Adelaide, 5000
- Completed
Research Site
Darlinghurst, 2010
- Recruiting
Research Site
Elizabeth Vale, 5112
- Recruiting
Research Site
Gosford, 2250
- Recruiting
Research Site
North Tamworth, 2340
- Recruiting
Research Site
Perth, 6000
- Recruiting
Research Site
Southport, 4215
- Recruiting
Research Site
St Leonards, 2065
- Recruiting
Research Site
Wollongong, 2500
Netherlands9 sites, 9 recruiting
- Recruiting
Research Site
Amersfoort, 3813 TZ
- Recruiting
Research Site
Amsterdam, 1105 AZ
- Recruiting
Research Site
Dordrecht, 3318 AT
- Recruiting
Research Site
Groningen, 9713 GZ
- Recruiting
Research Site
Hilversum, 1212 VG
- Recruiting
Research Site
Leiden, 2333 ZA
- Recruiting
Research Site
Maastricht, 6229 HX
- Recruiting
Research Site
Nieuwegein, 3435 CM
- Recruiting
Research Site
Zwolle, 8025 AB
Thailand9 sites, 5 recruiting
- Active, not recruiting
Research Site
Bangkok, 10330
- Recruiting
Research Site
Bangkok, 10400
- Recruiting
Research Site
Bangkok, 10700
- Recruiting
Research Site
Banphaeo, 74120
- Active, not recruiting
Research Site
Hat Yai, 90110
- Active, not recruiting
Research Site
Khon Kaen, 40002
- Recruiting
Research Site
Mueang, 50200
- Recruiting
Research Site
Phutthamonthon, 73170
- Active, not recruiting
Research Site
Ubonratchathani, 34000
Greece8 sites, 8 recruiting
- Recruiting
Research Site
Alexandroupoli, 68100
- Recruiting
Research Site
Athens, 11527
- Recruiting
Research Site
Heraklion, 71500
- Recruiting
Research Site
Ioannina, 45500
- Recruiting
Research Site
Pátrai, 26504
- Recruiting
Research Site
Thessaloniki, 54636
- Recruiting
Research Site
Thessaloniki, 54642
- Recruiting
Research Site
Thessaloniki, 57010
Malaysia8 sites, 8 recruiting
- Recruiting
Research Site
Ampang, 68000
- Recruiting
Research Site
Cheras, 56000
- Recruiting
Research Site
Ipoh, 30990
- Recruiting
Research Site
Kajang, 43000
- Recruiting
Research Site
Kota Bharu, 15586
- Recruiting
Research Site
Kuala Lumpur, 59100
- Recruiting
Research Site
Seremban, 70300
- Recruiting
Research Site
Seri Manjung, 32040
Taiwan8 sites, 8 recruiting
- Recruiting
Research Site
New Taipei City, 220
- Recruiting
Research Site
Taichung, 402
- Recruiting
Research Site
Taichung, 433004
- Recruiting
Research Site
Taipei, 10002
- Recruiting
Research Site
Taipei, 110
- Recruiting
Research Site
Taipei, TAIWAN
- Recruiting
Research Site
Taoyuan, 333
- Recruiting
Research Site
Yung Kang City, 71044
Vietnam8 sites, 7 recruiting
- Recruiting
Research Site
Can Tho, 920000
- Recruiting
Research Site
Da Nang, 550000
- Recruiting
Research Site
Haiphong, 180000
- Recruiting
Research Site
Hanoi, 10000
- Recruiting
Research Site
Ho Chi Minh City, 700000
- Withdrawn
Research Site
Ho Chi Minh City, 700000
- Recruiting
Research Site
Ho Chi Minh City, 70000
- Recruiting
Research Site
Rach Gia, 920000
Chile7 sites, 6 recruiting
- Recruiting
Research Site
Araucania, 4781151
- Recruiting
Research Site
Santiago, 7500922
- Recruiting
Research Site
Santiago, 8331143
- Recruiting
Research Site
Talcahuano, 4270918
- Recruiting
Research Site
Valdivia, 5090000
- Recruiting
Research Site
Victoria, 4720000
- Withdrawn
Research Site
Viña del Mar, 2540488
Denmark7 sites, 7 recruiting
- Recruiting
Research Site
Aalborg, 9000
- Recruiting
Research Site
Aarhus, 8200
- Recruiting
Research Site
Copenhagen E, 2100
- Recruiting
Research Site
Herlev, 2730
- Recruiting
Research Site
Herning, 7400
- Recruiting
Research Site
Holbæk, 4300
- Recruiting
Research Site
Kolding, 6000
Saudi Arabia7 sites, 6 recruiting
- Recruiting
Research Site
Al-Ahsa, 36428
- Recruiting
Research Site
Dammam, 31444
- Withdrawn
Research Site
Riyadh, 11211
- Recruiting
Research Site
Riyadh, 11426
- Recruiting
Research Site
Riyadh, 11462
- Not yet recruiting
Research Site
Riyadh, 12231
- Recruiting
Research Site
Riyadh/MENA, 11426
Sweden6 sites, 6 recruiting
- Recruiting
Research Site
Huddinge, 141 57
- Recruiting
Research Site
Karlstad, 651 85
- Recruiting
Research Site
Linköping, 581 85
- Recruiting
Research Site
Stockholm, 18288
- Recruiting
Research Site
Uppsala, 751 85
- Recruiting
Research Site
Vaxjo, 352 34
Egypt5 sites
- Withdrawn
Research Site
Cairo, 11566
- Withdrawn
Research Site
Cairo, 11734
- Withdrawn
Research Site
Cairo, 4540046
- Withdrawn
Research Site
Dakahlia, 35516
- Withdrawn
Research Site
Dakahlia, 7650030
Singapore4 sites, 4 recruiting
- Recruiting
Research Site
Singapore, 119074
- Recruiting
Research Site
Singapore, 169608
- Recruiting
Research Site
Singapore, 308433
- Recruiting
Research Site
Singapore, 529889
About this study
Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure
International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure
Read the detailed description
The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, HF events, or CV death in participants with CKD and HTN.
This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin.
Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months.
The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred (N = 845) ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within 6 weeks of the PACD. This period can be extended by AstraZeneca.
In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. Baxdrostat/placebo should not be administered without dapagliflozin: baxdrostat/placebo should be interrupted if dapagliflozin is interrupted (baxdrostat/placebo may be resumed with dapagliflozin, if dapagliflozin is resumed), and should be permanently discontinued if dapagliflozin is permanently discontinued. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.
- Conditions
- Chronic Kidney Disease and Hypertension
- Being tested
- Baxdrostat/dapagliflozin, Placebo/dapagliflozin
- Keywords
- Chronic kidney disease, Hypertension, Blood pressure, Baxdrostat, Dapagliflozin, Event-Driven, Outcome
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baxdrostat/dapagliflozinDrug
Also called Baxdrostat CIN-107
baxdrostat tablet
dapagliflozin tablet
Placebo/dapagliflozinDrug
dapagliflozin tablet
placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Baxdrostat/dapagliflozin | Experimental | Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose. Receives: Drug: Baxdrostat/dapagliflozin |
| Placebo/dapagliflozin | Placebo comparator | Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily. Receives: Drug: Placebo/dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death.
Time to the first occurrence of any of the components of the composite of:
Kidney disease progression
- ≥ 50% sustained decline in eGFR
- Onset of kidney failure:
- Sustained eGFR < 15 mL/min/1.73 m2 or
- Chronic dialysis treatment or
- Receiving a kidney transplant or
- Death with a renal primary cause (death due to kidney failure when dialysis is not given)
CV events
- HF with or without hospitalisation
- CV death
Measured: Up to 37 months
Secondary outcomes (4)
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure or CV death.
Time to the first occurrence of any of the components of the composite of:
- ≥ 50% sustained decline in eGFR
- Onset of kidney failure:
- Sustained eGFR < 15 mL/min/1.73 m2 or
- Chronic dialysis treatment or
- Receiving a kidney transplant or
- Death with a renal primary cause (death due to kidney failure when dialysis is not given)
- CV death
Measured: Up to 37 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MACE (Major Adverse Cardiac Events).
Time to the first occurrence of any of the components of the composite of: CV (cardiovascular) death, HF (heart failure) with and without hospitalization, Myocardial Infraction, Stroke
Measured: Up to 37 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of CV (cardiovascular) death.
Time to the first occurrence of any of the components of the composite of CV (cardiovascular) death
Measured: Up to 37 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of all-cause death.
Time to the first occurrence of any of the components of the composite of all-cause death
Measured: Up to 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start3 Mar 2025
- Primary completion18 Dec 2029 (estimated)
- Study completion18 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease and HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- International, multi-centre, randomised, double-blind, parallel-group, placebo-controlled, event-driven, outcome
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742723
- Sponsor's protocol ID
- D6972C00002
- Other IDs
- 2023-506460-14-00, 2023
- Acronym
- BaxDuo-Pacific
- Status last verified
- Nov 2026
- First submitted
- 16 Dec 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Yeung EK, Rangaswami J, Tuttle KR, Grams ME, Tangri N, Vaduganathan M, Neuen BL. A Framework for Risk-Based Implementation of Combination Therapy in CKD: Who, Why, When, and How? Clin J Am Soc Nephrol. 2026 Jun 23. doi: 10.2215/CJN.0000001158. Online ahead of print.
PubMed 42335037Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.
PubMed 40913594
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure
- ClinicalTrials.gov ID
- NCT06742723
- Acronym / sponsor ID
- BaxDuo-Pacific / D6972C00002
- Conditions
- Chronic Kidney Disease and Hypertension
- Keywords
- Chronic kidney disease, Hypertension, Blood pressure, Baxdrostat, Dapagliflozin, Event-Driven, Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 18 Dec 2029 (estimated)
- Study completion
- 18 Dec 2029 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure
Detailed description
The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, HF events, or CV death in participants with CKD and HTN.
This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin.
Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months.
The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred (N = 845) ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within 6 weeks of the PACD. This period can be extended by AstraZeneca.
In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. Baxdrostat/placebo should not be administered without dapagliflozin: baxdrostat/placebo should be interrupted if dapagliflozin is interrupted (baxdrostat/placebo may be resumed with dapagliflozin, if dapagliflozin is resumed), and should be permanently discontinued if dapagliflozin is permanently discontinued. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- International, multi-centre, randomised, double-blind, parallel-group, placebo-controlled, event-driven, outcome
| Arm | Type | Receives |
|---|---|---|
| Baxdrostat/dapagliflozin | Experimental | Drug: Baxdrostat/dapagliflozinParticipants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose. |
| Placebo/dapagliflozin | Placebo comparator | Drug: Placebo/dapagliflozinPatients will receive one dose of dapagliflozin comparator in combination with matching placebo daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
- Participants with (a) or (b):
- [obsolete]
- Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
- Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
Key exclusion criteria (14 listed)
- Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.
- Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
- Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
- For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.
- For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baxdrostat/dapagliflozinAlso: Baxdrostat CIN-107baxdrostat tablet dapagliflozin tablet | Drug | Baxdrostat/dapagliflozin |
| Placebo/dapagliflozindapagliflozin tablet placebo tablet | Drug | Placebo/dapagliflozin |
Primary outcome
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death.
Time frame: Up to 37 months
Time to the first occurrence of any of the components of the composite of: Kidney disease progression * ≥ 50% sustained decline in eGFR * Onset of kidney failure: * Sustained eGFR < 15 mL/min/1.73 m2 or * Chronic dialysis treatment or * Receiving a kidney transplant or * Death with a renal primary cause (death due to kidney failure when dialysis is not given) CV events * HF with or without hospitalisation * CV death
4 secondary outcomes
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure or CV death.
Time frame: Up to 37 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MACE (Major Adverse Cardiac Events).
Time frame: Up to 37 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of CV (cardiovascular) death.
Time frame: Up to 37 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of all-cause death.
Time frame: Up to 37 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 42335037Yeung EK, Rangaswami J, Tuttle KR, Grams ME, Tangri N, Vaduganathan M, Neuen BL. A Framework for Risk-Based Implementation of Combination Therapy in CKD: Who, Why, When, and How? Clin J Am Soc Nephrol. 2026 Jun 23. doi: 10.2215/CJN.0000001158. Online ahead of print.
- Derived from this study: PubMed 40913594Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
771 sites in 42 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baxdrostat/dapagliflozin in people with Chronic Kidney Disease and Hypertension, run by AstraZeneca at 771 sites in 42 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 771 sites in United States, Japan, China, Poland, Germany and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death. (time frame: Up to 37 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06742723, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.