Heart FailurePhase 3Prevent-HFNCT06677060
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
A Phase 3 study testing Baxdrostat and dapagliflozin in people with Heart Failure, run by AstraZeneca at 977 sites in 35 countries.
Trial summary
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Baxdrostat and dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11,300 participants
- Where
- 977 sitesin 35 countries
- Study dates
- 14 Mar 2025to 17 Dec 2029
- Phase
- Phase 3
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 40 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 ≥ 40 years old at the time of signing the informed consent.
- Diagnosed with T2DM and requiring treatment
- Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)
- History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit.
- At least one additional risk factor for HF:
- Age ≥ 70 years
Show all 11Show fewer
- UACR > 20 mg/g
- eGFR < 60 mL/min/1.73 m2
- History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)
- History of atrial fibrillation or atrial flutter
- NT-proBNP > 125 ng/L
Who cannot join
- Previously confirmed diagnosis and treatment of heart failure
- An eGFR < 30 mL/min/1.73 m2 at screening
- Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening
- Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) at screening
- Serum sodium < 135 mmol/L at screening, determined as per central laboratory assessment
- Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation
Show all 13Show fewer
- Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation
- Percutaneous coronary intervention within 1 month prior to randomisation
- Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
- Documented history of adrenal insufficiency
- Any dialysis (including for acute kidney injury) within 3 months prior to screening
- Any acute kidney injury within 3 months prior to screening
- Prohibited concomitant medications
Trial locations and contacts
977 sites in 35 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
977 sites in 35 countries
United States218 sites, 189 recruiting
- Recruiting
Research Site
Abilene, Texas, 79606
- Suspended
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Albany, Georgia, 31707
- Suspended
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Albany, New York, 12208
- Recruiting
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Albany, New York, 12211
- Recruiting
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Albuquerque, New Mexico, 87102
- Recruiting
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Albuquerque, New Mexico, 87108
- Recruiting
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Alexandria, Louisiana, 71303
- Withdrawn
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Anchorage, Alaska, 99508
- Not yet recruiting
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Arlington, Virginia, 22205
- Recruiting
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Atlanta, Georgia, 30303
- Recruiting
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Aurora, Colorado, 80012
- Recruiting
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Austin, Texas, 78704
- Recruiting
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Baltimore, Maryland, 21229
- Recruiting
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Beaumont, Texas, 77702
- Not yet recruiting
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Beaumont, Texas, 77706
- Recruiting
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Beavercreek, Ohio, 45431
- Recruiting
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Beltsville, Maryland, 20705
- Recruiting
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Birmingham, Alabama, 35205
- Not yet recruiting
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Boca Raton, Florida, 33487
- Recruiting
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Bossier City, Louisiana, 71111
- Recruiting
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Boston, Massachusetts, 02115
- Recruiting
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Bridgeport, Connecticut, 06606
- Recruiting
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Brooklyn, New York, 11201
- Recruiting
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Brooklyn, New York, 11220
- Recruiting
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Brownsville, Texas, 78526
- Recruiting
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Burke, Virginia, 22015
- Withdrawn
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Burlington, Vermont, 05401
- Recruiting
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Camp Hill, Pennsylvania, 17011
- Recruiting
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Canton, Georgia, 30114
- Recruiting
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Canton, Ohio, 44718
- Recruiting
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Carson City, Nevada, 89706
- Recruiting
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Centreville, Alabama, 35042
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Champaign, Illinois, 61822
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Charlotte, North Carolina, 28287
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Charlottesville, Virginia, 22911
- Recruiting
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Chicago, Illinois, 60616
- Recruiting
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Chicago, Illinois, 60621
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Chicago, Illinois, 60631
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Cincinnati, Ohio, 45219
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Cincinnati, Ohio, 45220
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Clearfield, Utah, 84015
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Cleveland, Tennessee, 37312
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Columbia, Missouri, 65201
- Recruiting
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Columbia, South Carolina, 29209
- Recruiting
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Columbus, Georgia, 31904
- Recruiting
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Columbus, Ohio, 43215
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Columbus, Ohio, 43228
- Not yet recruiting
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Concord, California, 94520
- Recruiting
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Cordele, Georgia, 31015
- Recruiting
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Crystal River, Florida, 34429
- Recruiting
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Dallas, Texas, 75390-9015
- Not yet recruiting
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Daly City, California, 94015
- Recruiting
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Dayton, Ohio, 45424
- Withdrawn
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Dublin, California, 94568
- Recruiting
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Duncanville, Texas, 75137
- Recruiting
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Durham, North Carolina, 27701
- Withdrawn
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Eatontown, New Jersey, 07724
- Recruiting
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El Dorado, Kansas, 67042
- Recruiting
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El Paso, Texas, 79905
- Recruiting
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El Paso, Texas, 79935
- Recruiting
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Englewood, Colorado, 80110
- Recruiting
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Fairfax, Virginia, 22033
- Recruiting
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Fairhope, Alabama, 36532
- Recruiting
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Falls Church, Virginia, 22042
- Recruiting
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Fargo, North Dakota, 58104
- Recruiting
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Farmington Hills, Michigan, 48336
- Recruiting
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Fayetteville, North Carolina, 28304
- Recruiting
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Flint, Michigan, 48532
- Withdrawn
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Fort Lauderdale, Florida, 33316
- Recruiting
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Fort Mill, South Carolina, 29715
- Recruiting
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Fort Myers, Florida, 33912
- Not yet recruiting
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Franklinton, Louisiana, 70438
- Withdrawn
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Gainesville, Florida, 32608
- Recruiting
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Gilbert, Arizona, 85296
- Completed
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Glendale, Arizona, 85308
- Not yet recruiting
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Goose Creek, South Carolina, 29445
- Withdrawn
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Green Bay, Wisconsin, 54303
- Not yet recruiting
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Greenville, North Carolina, 27834
- Withdrawn
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Greenville, South Carolina, 29615
- Recruiting
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Gurnee, Illinois, 60031
- Recruiting
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Horsham, Pennsylvania, 19044
- Not yet recruiting
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Houston, Texas, 77074
- Not yet recruiting
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Houston, Texas, 77082
- Recruiting
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Houston, Texas, 77084
- Not yet recruiting
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Houston, Texas, 77087
- Recruiting
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Houston, Texas, 77089
- Recruiting
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Huntington Beach, California, 92648
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Huntsville, Alabama, 35801
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Idaho Falls, Idaho, 83404
- Recruiting
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Indianapolis, Indiana, 46202
- Recruiting
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Inglewood, California, 90301
- Recruiting
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Island Lake, Illinois, 60042
- Recruiting
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Jacksonville, Florida, 32216
- Not yet recruiting
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Jacksonville, North Carolina, 28546
- Withdrawn
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Kalispell, Montana, 59901
- Recruiting
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Kansas City, Missouri, 64111
- Recruiting
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Kansas City, Missouri, 64151
- Withdrawn
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Kernersville, North Carolina, 27284
- Recruiting
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Kingwood, West Virginia, 26537
- Recruiting
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Kinston, North Carolina, 28504
- Recruiting
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La Jolla, California, 92037
- Recruiting
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Lakeland, Florida, 33813
- Withdrawn
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Lakewood, California, 90805
- Recruiting
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Lenexa, Kansas, 66219
- Withdrawn
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Lewisville, Texas, 75067
- Recruiting
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Lexington, Kentucky, 40509
- Recruiting
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Lincoln, California, 95648
- Recruiting
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Loma Linda, California, 92357
- Recruiting
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Los Angeles, California, 90035
- Recruiting
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Los Angeles, California, 90073
- Recruiting
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Louisville, Kentucky, 40218
- Recruiting
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Lutherville-Timonium, Maryland, 21093
- Recruiting
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Manassas, Virginia, 20110
- Recruiting
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Mankato, Minnesota, 56001
- Withdrawn
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Mansfield, Texas, 76063
- Recruiting
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Massapequa, New York, 11758
- Recruiting
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Maumee, Ohio, 43537
- Recruiting
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McAllen, Texas, 78501
- Recruiting
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McAllen, Texas, 78503
- Withdrawn
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Medford, Oregon, 97504
- Recruiting
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Mesquite, Texas, 75149
- Not yet recruiting
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Mesquite, Texas, 75149
- Recruiting
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Miami, Florida, 33125
- Completed
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Miami, Florida, 33135
- Recruiting
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Miami, Florida, 33173
- Recruiting
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Miami, Florida, 33175
- Not yet recruiting
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Miami, Florida, 33269
- Recruiting
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Miami Lakes, Florida, 33016
- Recruiting
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Midlothian, Virginia, 23112
- Withdrawn
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Milwaukee, Wisconsin, 53226
- Recruiting
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Minneapolis, Minnesota, 55417
- Recruiting
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Missoula, Montana, 59804
- Recruiting
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Mobile, Alabama, 36608
- Recruiting
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Monroe, North Carolina, 28112
- Not yet recruiting
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Morganton, North Carolina, 28655
- Recruiting
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Morgantown, West Virginia, 26505
- Recruiting
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Morristown, Tennessee, 37813
- Recruiting
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Mt. Pleasant, South Carolina, 29464
- Recruiting
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Munster, Indiana, 46321
- Recruiting
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Nashville, Tennessee, 37203
- Completed
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New Bedford, Massachusetts, 02740
- Recruiting
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New Bern, North Carolina, 28562
- Recruiting
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New York, New York, 10029
- Recruiting
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Newton, Kansas, 67114
- Recruiting
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Norfolk, Nebraska, 68701
- Recruiting
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Norfolk, Virginia, 23502
- Recruiting
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Norfolk, Virginia, 23504
- Withdrawn
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Norman, Oklahoma, 73069
- Recruiting
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North Charleston, South Carolina, 29405
- Suspended
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Ocoee, Florida, 34761
- Recruiting
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Ogden, Utah, 84405
- Recruiting
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Oklahoma City, Oklahoma, 73111
- Recruiting
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Oklahoma City, Oklahoma, 73120
- Not yet recruiting
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Olla, Louisiana, 71465
- Recruiting
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Omaha, Nebraska, 68134
- Recruiting
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Orlando, Florida, 32822
- Recruiting
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Owensboro, Kentucky, 42301
- Recruiting
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Paducah, Kentucky, 42001
- Recruiting
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Palmetto Bay, Florida, 33157
- Recruiting
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Paris, Texas, 75462
- Recruiting
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Park Ridge, Illinois, 60068
- Suspended
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Pearland, Texas, 77584
- Recruiting
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Pennington, New Jersey, 08534
- Recruiting
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Philadelphia, Pennsylvania, 19114
- Withdrawn
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Portsmouth, New Hampshire, 03801
- Recruiting
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Potomac, Maryland, 20854
- Not yet recruiting
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Puyallup, Washington, 98372
- Recruiting
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Queens Village, New York, 11428
- Recruiting
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Raleigh, North Carolina, 27607
- Recruiting
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Redmond, Washington, 98052
- Recruiting
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Renton, Washington, 98057
- Recruiting
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Richmond, Indiana, 47374
- Withdrawn
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Richmond, Virginia, 23249
- Not yet recruiting
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Riverview, Florida, 33578
- Recruiting
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Rocky Mount, North Carolina, 27804
- Recruiting
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Roslindale, Massachusetts, 02131
- Recruiting
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Sacramento, California, 95841
- Recruiting
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Saint Augustine, Florida, 32086
- Recruiting
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Salem, Virginia, 24153
- Recruiting
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San Antonio, Texas, 78231
- Recruiting
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San Antonio, Texas, 78257
- Recruiting
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San Diego, California, 92120
- Recruiting
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San Dimas, California, 91773
- Recruiting
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San Francisco, California, 94115
- Withdrawn
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San Francisco, California, 94121
- Recruiting
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Santa Maria, California, 93454
- Recruiting
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Scottdale, Pennsylvania, 15683
- Recruiting
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Sheffield, Alabama, 35660
- Suspended
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Sherman Oaks, California, 91403
- Recruiting
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Shreveport, Louisiana, 71101
- Recruiting
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Smithfield, Pennsylvania, 15478
- Recruiting
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Somerset, New Jersey, 08873
- Recruiting
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South Bend, Indiana, 46617
- Recruiting
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Spartanburg, South Carolina, 29301
- Recruiting
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St Louis, Missouri, 63136
- Recruiting
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Stamford, Connecticut, 06905
- Recruiting
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Stephenville, Texas, 76401
- Recruiting
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Sugar Land, Texas, 77479
- Recruiting
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Suwanee, Georgia, 30024
- Recruiting
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Tempe, Arizona, 85283
- Not yet recruiting
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Tempe, Arizona, 85284
- Recruiting
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Thousand Oaks, California, 91360
- Recruiting
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Toledo, Ohio, 43606
- Recruiting
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Tomball, Texas, 77375
- Recruiting
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Troy, Michigan, 48098
- Recruiting
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Tucker, Georgia, 30084
- Recruiting
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Tucson, Arizona, 85712
- Recruiting
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Vestavia Hills, Alabama, 35216
- Not yet recruiting
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Victoria, Texas, 77901
- Recruiting
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Waterbury, Connecticut, 06708
- Recruiting
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Weslaco, Texas, 78596
- Suspended
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West Chester, Pennsylvania, 19380
- Not yet recruiting
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Wichita, Kansas, 67214
- Withdrawn
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Wichita, Kansas, 67218
- Recruiting
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Wilmington, North Carolina, 28401
- Recruiting
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Woodstock, Georgia, 30189
- Recruiting
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Woodway, Texas, 76712
- Recruiting
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Ypsilanti, Michigan, 48197
Germany68 sites, 52 recruiting
- Recruiting
Research Site
Aachen, 52074
- Recruiting
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Amberg, 92224
- Withdrawn
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Bad Homburg, 61348
- Recruiting
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Bad Oeynhausen, 32545
- Recruiting
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Bamberg, 96049
- Recruiting
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Bechhofen, 66894
- Withdrawn
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Berlin, 10367
- Recruiting
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Berlin, 10789
- Recruiting
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Berlin, 12203
- Recruiting
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Berlin, 13187
- Recruiting
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Berlin, 13353
- Not yet recruiting
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Berlin, 13405
- Recruiting
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Berlin, 13597
- Recruiting
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Bochum, 44789
- Recruiting
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Bochum, 44869
- 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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Bremen, 28277
- Recruiting
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Cologne, 51065
- Withdrawn
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Cologne, 51069
- Recruiting
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Deggingen, 73326
- Withdrawn
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Dresden, 01069
- Recruiting
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Dresden, 01277
- Recruiting
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Elsterwerda, 04910
- Recruiting
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Essen, 45136
- Recruiting
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Essen, 45355
- Withdrawn
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Essen, 45355
- Recruiting
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Frankfurt, 60596
- Recruiting
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Freiburg im Breisgau, 79106
- Withdrawn
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Friedrichsthal, 66299
- Recruiting
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Fulda, 36037
- Recruiting
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Gelnhausen, 63571
- Recruiting
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Görlitz, 02828
- Recruiting
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Hamburg, 21109
- Recruiting
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Hamburg, 22041
- Recruiting
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Hamburg, 22459
- Recruiting
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Hamburg, 22607
- Withdrawn
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Haßloch, 67454
- Recruiting
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Heidelberg, 69120
- Recruiting
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Homburg, 66424
- Recruiting
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Kaiserslautern, 67655
- Recruiting
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Kassel, 34121
- Recruiting
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Langen, 63225
- Recruiting
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Leipzig, 04179
- Recruiting
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Leipzig, 04249
- Recruiting
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Leipzig, 04347
- Withdrawn
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Ludwigshafen, 67059
- Recruiting
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Ludwigshafen, 67063
- Withdrawn
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Mannheim, 68165
- Terminated
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Markkleeberg, 04416
- Withdrawn
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Munich, 80809
- Withdrawn
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Münster, 48153
- Recruiting
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Naunhof, 04683
- Recruiting
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Neuruppin, 16816
- Recruiting
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Nittendorf, 93152
- Recruiting
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Obertshausen, 63179
- Recruiting
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Oldenburg, 23758
- Recruiting
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Osnabrück, 49080
- Recruiting
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Papenburg, 26871
- Recruiting
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Pirna, 01796
- Withdrawn
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Potsdam, 14473
- Recruiting
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Ratingen, 40882
- Recruiting
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Reinfeld (Holstein), 23858
- Withdrawn
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Völklingen, 66333
- Recruiting
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Wallerfing, 94574
- Withdrawn
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Wangen, 88239
- Recruiting
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Weinheim, 69469
- Withdrawn
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Zwenkau, 04442
China57 sites, 55 recruiting
- Recruiting
Research Site
Baotou, 14010
- Withdrawn
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Beijing, 100029
- Recruiting
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Beijing, 100029
- Recruiting
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Beijing, 100050
- Recruiting
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Changchun, 130021
- Recruiting
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Changchun, 130033
- Recruiting
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Changde, 415000
- Recruiting
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Changsha, 410011
- Recruiting
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Changsha, 410015
- Recruiting
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Changzhou, 272100
- Recruiting
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Chengdu, 610000
- Recruiting
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Chengdu, 610041
- Recruiting
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Chifeng, 024000
- Recruiting
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Chongqing, 400014
- Recruiting
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Chongqing, 400042
- Recruiting
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Guangzhou, 510100
- Recruiting
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Guangzhou, 511486
- Recruiting
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Harbin, 150000
- Withdrawn
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Hefei, 230001
- Recruiting
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Hengyang, 421001
- Recruiting
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Heze, 274099
- Recruiting
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Huangshi, 435000
- Recruiting
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Huizhou, 516002
- Recruiting
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Jinan, 250001
- Recruiting
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Jining, 272006
- Recruiting
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Kaifeng, 475000
- Recruiting
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Liaocheng, 252000
- Recruiting
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Linyi, 276003
- Recruiting
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Lishui, 323000
- Recruiting
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Luoyang, 471000
- Recruiting
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Luoyang, 471001
- Recruiting
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Meihekou, 135022
- Recruiting
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Nanchang, 330009
- Recruiting
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Nanjing, 210008
- Recruiting
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Nantong, 226001
- Recruiting
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Nanyang, 473000
- Recruiting
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Panjin, 124009
- Recruiting
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Pingxiang, 337055
- Recruiting
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Sanya, 572000
- Recruiting
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Shanghai, 200240
- Recruiting
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Shanghai, 201114
- Recruiting
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Shenyang, 110016
- Recruiting
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Siping, 136000
- Recruiting
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Suzhou, 215004
- Recruiting
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Taiyuan, 030024
- Recruiting
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Taizhou, 317000
- Recruiting
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Tianjin, 300000
- Recruiting
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Wenzhou, 325000
- Recruiting
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Wuhan, 430010
- Recruiting
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Wuhan, 430060
- Recruiting
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Xi'an, 710061
- Recruiting
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Xi'an, 710068
- Recruiting
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Xianyang, 750004
- Recruiting
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Xuzhou, 221009
- Recruiting
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Yinchuan, 750004
- Recruiting
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Zhumadian, 463000
- Recruiting
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Zigong, 643000
Poland52 sites, 43 recruiting
- Withdrawn
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Biała Podlaska, 21-500
- Recruiting
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Bialystok, 15-481
- Withdrawn
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Bydgoszcz, 85-095
- Withdrawn
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Chojnice, 89-600
- Recruiting
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Chojnice, 89-600
- Recruiting
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Chrzanów, 32-500
- Recruiting
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Częstochowa, 42-202
- Recruiting
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Gdansk, 80-214
- Withdrawn
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Gdansk, 80-286
- Recruiting
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Gdynia, 81-157
- Recruiting
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Gdynia, 81-537
- Recruiting
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Jasło, 38-200
- Recruiting
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Katowice, 40-040
- Recruiting
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Katowice, 40-081
- Recruiting
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Katowice, 40-156
- Recruiting
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Katowice, 40-600
- Recruiting
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Katowice, 40-748
- Withdrawn
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Katowice, 40-752
- Recruiting
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Krakow, 31-121
- Recruiting
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Krakow, 31-322
- Recruiting
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Lodz, 90-302
- Withdrawn
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Lodz, 90-549
- Recruiting
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Lublin, 20-068
- Withdrawn
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Lublin, 20-518
- Recruiting
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Lublin, 20-718
- Recruiting
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Lublin, 20-857
- Recruiting
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Myszków, 42-300
- Recruiting
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Olsztyn, 10-165
- Recruiting
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Ostrów Mazowiecka, 07-300
- Recruiting
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Piekary Śląskie, 41-940
- Recruiting
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Płock, 09-407
- Recruiting
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Poznan, 60-111
- Recruiting
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Poznan, 60-309
- Recruiting
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Poznan, 60-702
- Recruiting
Research Site
Poznan, 61-848
- Recruiting
Research Site
Przemyśl, 37-700
- Recruiting
Research Site
Radzionków, 41-922
- Recruiting
Research Site
Rzeszów, 35-205
- Recruiting
Research Site
Skórzewo, 60-185
- Withdrawn
Research Site
Szczecin, 71-434
- Recruiting
Research Site
Szczecin, 71-526
- Recruiting
Research Site
Tarnów, 33-100
- Recruiting
Research Site
Torun, 87-100
- Recruiting
Research Site
Warsaw, 00-124
- Recruiting
Research Site
Warsaw, 00-872
- Recruiting
Research Site
Warsaw, 02-507
- Recruiting
Research Site
Warsaw, 02-758
- Recruiting
Research Site
Warsaw, 02-798
- Recruiting
Research Site
Warsaw, 04-501
- Recruiting
Research Site
Warsaw, 04-628
- Recruiting
Research Site
Wroclaw, 50-981
- Withdrawn
Research Site
Zabrze, 41-800
Japan45 sites, 42 recruiting
- Recruiting
Research Site
Amagasaki-shi, 660-8550
- Recruiting
Research Site
Asahikawa-shi, 070-8610
- Recruiting
Research Site
Azumino-shi, 399-8292
- Recruiting
Research Site
Chūōku, 103-0002
- Recruiting
Research Site
Fukui-shi, 910-8526
- Recruiting
Research Site
Hakusan-shi, 924-8588
- Recruiting
Research Site
Himeji, 670-8560
- Recruiting
Research Site
Itabashi-ku, 173-0015
- Recruiting
Research Site
Izumo-shi, 693-8501
- Recruiting
Research Site
Kakegawa-shi, 436-8555
- Recruiting
Research Site
Kamakura-shi, 247-8533
- Recruiting
Research Site
Kanazawa, 920-8650
- Recruiting
Research Site
Kawaguchi-shi, 332-8558
- Recruiting
Research Site
Kishiwada-shi, 596-0042
- Recruiting
Research Site
Kita-ku, 114-0001
- Completed
Research Site
Kyoto, 601-1495
- Recruiting
Research Site
Kyoto, 605-0981
- Recruiting
Research Site
Kyoto, 606-8507
- Recruiting
Research Site
Matsudo-shi, 271-0077
- Recruiting
Research Site
Meguro-ku, 153-0051
- Recruiting
Research Site
Mito, 311-4198
- Recruiting
Research Site
Miyazaki, 880-0834
- Recruiting
Research Site
Nagano, 399-8695
- Recruiting
Research Site
Ogaki-shi, 503-8502
- Recruiting
Research Site
Ōita, 870-8511
- Recruiting
Research Site
Ōmihachiman, 523-0082
- Recruiting
Research Site
Osaka, 530-8480
- Completed
Research Site
Osaka, 534-0024
- Recruiting
Research Site
Osaka, 553-0003
- Recruiting
Research Site
Osaka, 558-8558
- Recruiting
Research Site
Saitama-shi, 338-0837
- Recruiting
Research Site
Sendai, 980-8574
- Recruiting
Research Site
Sendai, 983-0039
- Recruiting
Research Site
Shizuoka, 424-0911
- Recruiting
Research Site
Suita-shi, 564-8565
- Withdrawn
Research Site
tabashi City, 173-8606
- Recruiting
Research Site
Takamatsu, 760-0017
- Recruiting
Research Site
Takatsuki-shi, 569-1192
- Recruiting
Research Site
Toyota-Shi, 471-8513
- Recruiting
Research Site
Tsuchiura-shi, 300-0028
- Recruiting
Research Site
Ueda-shi, 386-8610
- Recruiting
Research Site
Uwajima-shi, 798-8510
- Recruiting
Research Site
Yanagawa-shi, 832-0077
- Recruiting
Research Site
Yokkaichi-shi, 510-8561
- Recruiting
Research Site
Yokohama, 230-8765
Canada37 sites, 34 recruiting
- Recruiting
Research Site
Abbotsford British Columbia, British Columbia, V2S 0C2
- Recruiting
Research Site
Calgary, Alberta, T2H 2G4
- Recruiting
Research Site
Calgary, Alberta, T2V 4J2
- Withdrawn
Research Site
Cambridge, Ontario, N1R 6V6
- Recruiting
Research Site
Guelph, Ontario, N1H 1B1
- Recruiting
Research Site
Halifax, Nova Scotia, B3H 1V7
- Recruiting
Research Site
Hamilton, Ontario, L8J 0B6
- Recruiting
Research Site
Hamilton, Ontario, L8L 5G4
- Recruiting
Research Site
Laval, Quebec, H7T 2P5
- Recruiting
Research Site
Lévis, Quebec, G6V 9H4
- Recruiting
Research Site
Markham, Ontario, L3S 0A2
- Recruiting
Research Site
Mirabel, Quebec, J7J 2K8
- Recruiting
Research Site
Moncton, New Brunswick, E1C 2Z3
- Recruiting
Research Site
Montreal, Quebec, H1T 1C8
- Recruiting
Research Site
Montreal, Quebec, H4A 3T2
- Recruiting
Research Site
Newmarket, Ontario, L3Y 2P6
- Recruiting
Research Site
North York, Ontario, M6B 3H7
- Withdrawn
Research Site
North York, Ontario, M9N 1W4
- Recruiting
Research Site
Oakville, Ontario, L6K 3W7
- Recruiting
Research Site
Ottawa, Ontario, K2J 0V2
- Recruiting
Research Site
Québec, Quebec, G1G 5X1
- Recruiting
Research Site
Québec, Quebec, G1V 4G5
- Recruiting
Research Site
Regina, Saskatchewan, S4P 0W5
- Recruiting
Research Site
Saint John, New Brunswick, E2L 4L2
- Recruiting
Research Site
Saint-Charles-Borromée, Quebec, J6E 6J2
- Recruiting
Research Site
Sarnia, Ontario, N7T 4X3
- Recruiting
Research Site
Scarborough Village, Ontario, M1B 4Z8
- Recruiting
Research Site
Sherbrooke, Quebec, J1H 5N4
- Recruiting
Research Site
Sherwood Park, Alberta, T8H 0N2
- Recruiting
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6
- Recruiting
Research Site
Sydney, Nova Scotia, B1P 1P3
- Recruiting
Research Site
Terrebonne, Quebec, J6X 4P7
- Recruiting
Research Site
Toronto, Ontario, M4G 3E8
- Withdrawn
Research Site
Toronto, Ontario, M5B 1W8
- Recruiting
Research Site
Toronto, Ontario, M6C 1C2
- Recruiting
Research Site
Toronto, Ontario, M6G 1M2
- Recruiting
Research Site
Trois-Rivières, Quebec, G9A 4P3
France31 sites, 28 recruiting
- Recruiting
Research Site
Amiens, 80054
- Recruiting
Research Site
Angers, 49933
- Recruiting
Research Site
Aurillac, 15002
- Recruiting
Research Site
Besançon, 25030
- Recruiting
Research Site
Bobigny, 93000
- Recruiting
Research Site
Bois-Guillaume, 76230
- Recruiting
Research Site
Brest, 29200
- Recruiting
Research Site
Caen, 14033
- Recruiting
Research Site
Cholet, 49300
- Withdrawn
Research Site
Clermont-Ferrand, 63000
- Recruiting
Research Site
Colombes, 92700
- Recruiting
Research Site
Corbeil-Essonnes, 91106
- Recruiting
Research Site
Dijon, 2100
- Recruiting
Research Site
La Roche-sur-Yon, 85925
- Recruiting
Research Site
La Rochelle, 17000
- Recruiting
Research Site
Le Coudray, 28630
- Withdrawn
Research Site
Le Creusot, 71206
- Recruiting
Research Site
Lyon, 69007
- Recruiting
Research Site
Marseille, 13385
- Withdrawn
Research Site
Montpellier, 34295
- Recruiting
Research Site
Nantes, 44093
- Recruiting
Research Site
Narbonne, 11108
- Recruiting
Research Site
Nîmes, 30029
- Recruiting
Research Site
Paris, 75010
- Recruiting
Research Site
Paris, 75014
- Recruiting
Research Site
Paris, 75018
- Recruiting
Research Site
Paris, 75908
- Recruiting
Research Site
Pierre-Bénite, 69495
- Recruiting
Research Site
Toulouse, 31059
- Recruiting
Research Site
Vandœuvre-lès-Nancy, 54511
- Recruiting
Research Site
Villeurbanne, 69100
Italy28 sites, 27 recruiting
- Recruiting
Research Site
Alessandria, 15100
- Recruiting
Research Site
Bari, 70124
- Recruiting
Research Site
Bergamo, 24127
- Recruiting
Research Site
Brescia, 25123
- Recruiting
Research Site
Chiavari, 16034
- Recruiting
Research Site
Cona, 44124
- Recruiting
Research Site
Foggia, 71100
- Recruiting
Research Site
Milan, 20122
- Recruiting
Research Site
Milan, 20132
- Recruiting
Research Site
Milan, 20138
- Recruiting
Research Site
Milan, 20154
- Recruiting
Research Site
Milan, 20162
- Withdrawn
Research Site
Mondovì, 12084
- Recruiting
Research Site
Monza, 20900
- Recruiting
Research Site
Naples, 80131
- Recruiting
Research Site
Novara, 28100
- Recruiting
Research Site
Orbassano, 10043
- Recruiting
Research Site
Palermo, 90127
- Recruiting
Research Site
Pavia, 27100
- Recruiting
Research Site
Potenza, 85100
- Recruiting
Research Site
Roma, 00128
- Recruiting
Research Site
Roma, 00133
- Recruiting
Research Site
Roma, 161
- Recruiting
Research Site
Rome, 00168
- Recruiting
Research Site
Rozzano, 20089
- Recruiting
Research Site
Siena, 53100
- Recruiting
Research Site
Torino, 10126
- Recruiting
Research Site
Udine, 33100
India27 sites, 21 recruiting
- Withdrawn
Research Site
Ahmedabad, 380054
- Withdrawn
Research Site
Ajmer, 305001
- Withdrawn
Research Site
Bangalore, 560069
- Recruiting
Research Site
Belagavi, 590010
- Recruiting
Research Site
Dehradun, 248001
- Not yet recruiting
Research Site
Delhi, 110060
- Recruiting
Research Site
Delhi, 110062
- Recruiting
Research Site
Gūrgaon, 122001
- Recruiting
Research Site
Hyderabad, 500 034
- Withdrawn
Research Site
Hyderabad, 500018
- Recruiting
Research Site
Hyderabad, 500035
- Recruiting
Research Site
Hyderabad, 500082
- Recruiting
Research Site
Kanpur, 208001
- Withdrawn
Research Site
Karamsad, 388345
- Recruiting
Research Site
Kolkata, 700014
- Recruiting
Research Site
Kolkata, 700020
- Withdrawn
Research Site
Lucknow, 226010
- Not yet recruiting
Research Site
Mumbai, 400012
- Not yet recruiting
Research Site
Nagpur, 440010
- Recruiting
Research Site
Nagpur, 441108
- Recruiting
Research Site
New Delhi, 100049
- Recruiting
Research Site
New Delhi, 110002
- Recruiting
Research Site
New Delhi, 110017
- Recruiting
Research Site
Secunderabad, 500003
- Recruiting
Research Site
Surat, 395001
- Recruiting
Research Site
Surat, 396007
- Recruiting
Research Site
Vijayawada, 520 008
Hungary25 sites, 20 recruiting
- Recruiting
Research Site
Balatonfüred, 8230
- Withdrawn
Research Site
Balatonfüred, 8230
- Recruiting
Research Site
Békéscsaba, 5600
- Recruiting
Research Site
Budapest, 1033
- Recruiting
Research Site
Budapest, 1036
- Recruiting
Research Site
Budapest, 1083
- Recruiting
Research Site
Budapest, 1102
- Recruiting
Research Site
Budapest, 1106
- Recruiting
Research Site
Budapest, 1122
- Not yet recruiting
Research Site
Budapest, 1134
- Recruiting
Research Site
Budapest, 1148
- Recruiting
Research Site
Debrecen, 4032
- Withdrawn
Research Site
Gyöngyös, 3200
- Recruiting
Research Site
Kalocsa, 6300
- Withdrawn
Research Site
Nyíregyháza, 4400
- Recruiting
Research Site
Nyíregyháza, 4400
- Withdrawn
Research Site
Nyíregyháza, 4405
- Recruiting
Research Site
Nyíregyháza-Sóstóhegy, 4481
- Withdrawn
Research Site
Orosháza, 5900
- Recruiting
Research Site
Pécs, 7623
- Recruiting
Research Site
Pécs, 7635
- Recruiting
Research Site
Szeged, 6724
- Recruiting
Research Site
Székesfehérvár, 8000
- Recruiting
Research Site
Szigetvár, 7900
- Recruiting
Research Site
Szolnok, 5000
Brazil23 sites, 21 recruiting
- Recruiting
Research Site
Belém, 66073-005
- Recruiting
Research Site
Blumenau, 89010-022
- Recruiting
Research Site
Bragança Paulista, 12916-542
- Recruiting
Research Site
Brasília, 71625-009
- 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, 80030-480
- Recruiting
Research Site
Curitiba, 80810-050
- Withdrawn
Research Site
Juiz de Fora, 36033-318
- Recruiting
Research Site
Natal, 59020-500
- Recruiting
Research Site
Porto Alegre, 90160-093
- Recruiting
Research Site
Porto Alegre, 90610-001
- Recruiting
Research Site
Porto Alegre, 90630-165
- Recruiting
Research Site
Porto Alegre, 91350-200
- Recruiting
Research Site
Rio de Janeiro, 20241-180
- Recruiting
Research Site
São José do Rio Preto, 15090-000
- Recruiting
Research Site
São José dos Campos, 12230-001
- Withdrawn
Research Site
São Paulo, 01228-000
- Recruiting
Research Site
São Paulo, 01236-030
- Recruiting
Research Site
São Paulo, 04012-180
- Recruiting
Research Site
São Paulo, 05403-000
- Recruiting
Research Site
Tatuí, 18270-170
South Africa21 sites, 19 recruiting
- Recruiting
Research Site
Bellville, 7530
- Recruiting
Research Site
Benoni, 1501
- Recruiting
Research Site
Brackenfell, 7560
- Withdrawn
Research Site
Cape Town, 1730
- Recruiting
Research Site
Cape Town, 7500
- Recruiting
Research Site
Centurion, 0157
- Recruiting
Research Site
Claremont, 7708
- Recruiting
Research Site
Diepkloof, Soweto, 2013
- Recruiting
Research Site
Durban, 4001
- Recruiting
Research Site
Durban, 4052
- Recruiting
Research Site
East London, 5219
- Recruiting
Research Site
eMkhomazi, 4170
- Recruiting
Research Site
Johannesburg, 1827
- Recruiting
Research Site
Lenasia, 1827
- Recruiting
Research Site
Midrand, 1685
- Recruiting
Research Site
Paarl, 7646
- Withdrawn
Research Site
Pretoria, 0184
- Recruiting
Research Site
Pretoria, 0186
- Recruiting
Research Site
Somerset West, 7130
- Recruiting
Research Site
Wentworth, 4032
- Recruiting
Research Site
Worcester, 6850
Czechia20 sites, 19 recruiting
- Recruiting
Research Site
Benešov, 256 01
- Recruiting
Research Site
Brandýs nad Labem, 250 01
- Recruiting
Research Site
Brno, 603 00
- Recruiting
Research Site
Brno, 639 00
- Recruiting
Research Site
Chlumec nad Cidlinou, 503 51
- Recruiting
Research Site
Hodonín, 695 01
- Recruiting
Research Site
Humpolec, 396 01
- Recruiting
Research Site
Jaroměř, 551 01
- Recruiting
Research Site
Jílové u Prahy, 254 01
- Recruiting
Research Site
Krnov, 794 01
- Completed
Research Site
Olomouc, 772 00
- Recruiting
Research Site
Ostrava, 702 00
- Recruiting
Research Site
Pilsen, 301 00
- Recruiting
Research Site
Police nad Metují, 549 54
- Recruiting
Research Site
Prague, 101 00
- Recruiting
Research Site
Prague, 104 00
- Recruiting
Research Site
Prague, 12808
- Recruiting
Research Site
Prague, 149 00
- Recruiting
Research Site
Prague, 150 00
- Recruiting
Research Site
Prague, 190 14
Peru19 sites, 15 recruiting
- Recruiting
Research Site
Bellavista, CALLAO 2
- Recruiting
Research Site
Callao, Bellavista
- Recruiting
Research Site
Chorrillos, Lima 9
- Not yet recruiting
Research Site
Cusco, CUSCO 01
- Recruiting
Research Site
Lima, 14
- Recruiting
Research Site
Lima, 15036
- Not yet recruiting
Research Site
Lima, 15038
- Recruiting
Research Site
Lima, 15046
- Withdrawn
Research Site
Lima, 15072
- Withdrawn
Research Site
Lima, 15074
- Recruiting
Research Site
Lima, 15088
- Not yet recruiting
Research Site
Lima, 15102
- Withdrawn
Research Site
Lima, 15131
- Withdrawn
Research Site
Lima, L18
- Not yet recruiting
Research Site
Lima, L41
- Recruiting
Research Site
Lima, LIMA 01
- Not yet recruiting
Research Site
Lima, LIMA 11
- Recruiting
Research Site
Lima, LIMA 41
- Recruiting
Research Site
Piura, 20001
Taiwan18 sites, 18 recruiting
- Recruiting
Research Site
Changhua, 500
- Recruiting
Research Site
Hsinchu, 300
- Recruiting
Research Site
Hualien City, 970473
- Recruiting
Research Site
Kaohsiung City, 80756
- Recruiting
Research Site
New Taipei City, 231
- Recruiting
Research Site
Taichung, 40201
- Recruiting
Research Site
Taichung, 404
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Taichung, 433004
- Recruiting
Research Site
Tainan, 710
- Recruiting
Research Site
Taipei, 10002
- Recruiting
Research Site
Taipei, 10449
- Recruiting
Research Site
Taipei, 110
- Recruiting
Research Site
Taipei, 11101
- Recruiting
Research Site
Taipei, 11217
- Recruiting
Research Site
Taipei, 11490
- Recruiting
Research Site
Taipei, 116
- Recruiting
Research Site
Taoyuan, 333
Argentina17 sites, 17 recruiting
- Recruiting
Research Site
Buenos Aires, C1120AAC
- Recruiting
Research Site
Buenos Aires, C1425AGC
- Recruiting
Research Site
Caba, C1128AAF
- Recruiting
Research Site
CABA, C1056ABH
- Recruiting
Research Site
CABA, C1119ACN
- Recruiting
Research Site
Ciudad de Buenos Aires, C1428DCO
- Not yet recruiting
Research Site
Córdoba, 5000
- Recruiting
Research Site
Córdoba, X5003DCP
- Not yet recruiting
Research Site
La Plata, B1904
- Not yet recruiting
Research Site
Mar del Plata, B7600FZN
- Recruiting
Research Site
Mar del Plata, B7600GNY
- Recruiting
Research Site
Rosario, 2000
- Recruiting
Research Site
Rosario, S2000PBJ
- Recruiting
Research Site
San Nicolás, B2900DMH
- Not yet recruiting
Research Site
San Nicolás de los Arroyos, B2900DPA
- Recruiting
Research Site
San Vicente, 5006
- Recruiting
Research Site
Santa Fe, S3000FWO
Bulgaria17 sites, 15 recruiting
- Recruiting
Research Site
Haskovo, 6300
- Recruiting
Research Site
Panagyurishte, 4500
- Withdrawn
Research Site
Petrich, 2850
- Recruiting
Research Site
Pleven, 5800
- Withdrawn
Research Site
Pleven, 5804
- Recruiting
Research Site
Plovdiv, 4003
- Recruiting
Research Site
Rousse, 7000
- Recruiting
Research Site
Shumen, 9700
- Recruiting
Research Site
Sofia, 1000
- Recruiting
Research Site
Sofia, 1309
- Recruiting
Research Site
Sofia, 1404
- Recruiting
Research Site
Sofia, 1431
- Recruiting
Research Site
Sofia, 1527
- Recruiting
Research Site
Sofia, 1618
- Recruiting
Research Site
Sofia, 1680
- Recruiting
Research Site
Stara Zagora, 6003
- Recruiting
Research Site
Varna, 9000
Mexico17 sites, 15 recruiting
- Withdrawn
Research Site
Acapulco, 39670
- Recruiting
Research Site
Aguascalientes, 20230
- Recruiting
Research Site
Cuauhtémoc, 6720
- Recruiting
Research Site
Cuernavaca, 62448
- Not yet recruiting
Research Site
Culiacán, 80200
- Recruiting
Research Site
Culiacán, 80230
- Recruiting
Research Site
Durango, 34000
- Recruiting
Research Site
Guadalajara, 44670
- Withdrawn
Research Site
Guadalajara, 44670
- Recruiting
Research Site
Mexico City, 10700
- Recruiting
Research Site
Monterrey, 64060
- Recruiting
Research Site
Querétaro City, 76000
- Recruiting
Research Site
San Juan del Río, 76800
- Not yet recruiting
Research Site
Veracruz, 91910
- Not yet recruiting
Research Site
Xalapa, 91020
- Recruiting
Research Site
Xalapa, 91193
- Recruiting
Research Site
Zapopan, 45138
Netherlands17 sites, 17 recruiting
- Recruiting
Research Site
's-Hertogenbosch, 5223 LA
- Recruiting
Research Site
Almelo, 7609 PP
- Recruiting
Research Site
Amsterdam, 1081 GM
- Recruiting
Research Site
Amsterdam, 1105 AZ
- Recruiting
Research Site
Born, 6121 XK
- Recruiting
Research Site
Deventer, 7416 SE
- Recruiting
Research Site
Ede, 6716 RP
- Recruiting
Research Site
Enschede, 7512 KZ
- Recruiting
Research Site
Haarlem, 2035 RC
- Recruiting
Research Site
Harderwijk, 3844
- Recruiting
Research Site
Hoogeveen, 7909 AA
- Recruiting
Research Site
Nijmegen, 6525 GA
- Recruiting
Research Site
Roosendaal, 4708 AE
- Recruiting
Research Site
Rotterdam, 3015GD
- Recruiting
Research Site
Rotterdam, 3045 PM
- Recruiting
Research Site
Venlo, 5912 BL
- Recruiting
Research Site
Zwolle, 8025AZ
Slovakia17 sites, 15 recruiting
- Recruiting
Research Site
Bratislava, 831 03
- Recruiting
Research Site
Bratislava, 83101
- Recruiting
Research Site
Bratislava, 83106
- Recruiting
Research Site
Brezno, 977 01
- Recruiting
Research Site
Handlová, 972 51
- Recruiting
Research Site
Košice, 04001
- Recruiting
Research Site
Košice, 04022
- Recruiting
Research Site
Ľubochňa, 03491
- Recruiting
Research Site
Lučenec, 984 01
- Recruiting
Research Site
Malacky, 901 22
- Recruiting
Research Site
Námestovo, 029 01
- Recruiting
Research Site
Prešov, 080 01
- Recruiting
Research Site
Prievidza, 97101
- Recruiting
Research Site
Rimavská Sobota, 979 01
- Withdrawn
Research Site
Rožňava, 048 01
- Withdrawn
Research Site
Sabinov, 08301
- Recruiting
Research Site
Svidník, 08901
United Kingdom17 sites, 14 recruiting
- Recruiting
Research Site
Aberdeen, AB25 2ZN
- Recruiting
Research Site
Chesterfield, S40 4AA
- Recruiting
Research Site
Dundee, DD1 9SY
- Withdrawn
Research Site
Gatley, SK8 4NQ
- Recruiting
Research Site
Glasgow, G31 2ER
- Recruiting
Research Site
Glasgow, G51 4TF
- Recruiting
Research Site
London, E11BB
- Recruiting
Research Site
Norwich, NR128DU
- Recruiting
Research Site
Penzance, TR18 3DX
- Withdrawn
Research Site
Redruth, TR16 4ET
- Recruiting
Research Site
Sandbach, CW11 1EQ
- Withdrawn
Research Site
Southampton, SO303JB
- Recruiting
Research Site
Swansea, SA6 6NL
- Recruiting
Research Site
Weston-super-Mare, BS24 7PR
- Recruiting
Research Site
Wolverhampton, WV10 0QP
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Baia Mare, 430124
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Bucharest, 010825
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Bucharest, 031818
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Eskişehir, 26040
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Seoul, 02841
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Ternopil, 46000
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Athens, 11528
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About this study
Official title: A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF.
The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1.
Read more
Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation.
Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months.
The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD.
In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.
- Conditions
- Heart Failure
- Being tested
- Baxdrostat and dapagliflozin, Placebo and dapagliflozin
- Keywords
- Heart failure: Baxdrostat; Dapagliflozin; cardiovascular
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baxdrostat and dapagliflozinDrug
Also called Baxdrostat CIN-107
baxdrostat tablet and dapagliflozin tablet
Placebo and dapagliflozinOther
placebo tablet and dapagliflozin tablet
| Study group | Role | What they receive |
|---|---|---|
| Baxdrostat/Dapagliflozin | Experimental | Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose. Receives: Drug: Baxdrostat and dapagliflozin |
| Placebo/Dapagliflozin | Experimental | Patients will receive a dose of dapagliflozin in combination with matching placebo Receives: Other: Placebo and dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death
Time to first occurrence of any of the components of the composite of:
- Hospitalisation for HF
- HF without hospitalisation
- CV death
Measured: Event driven; Up to 38 months
Secondary outcomes (5)
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of hospitalisation for HF or CV death
Time to first occurrence of any of the components of the composite of:
- Hospitalisation for HF
- CV death
Measured: Event driven; Up to 38 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events
Time to first occurrence of any of the components of the composite of:
- Hospitalisation for HF
- HF without hospitalisation
Measured: Event driven; Up to 38 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death
Time to CV death
Measured: Event driven; Up to 38 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause mortality
Time to all-cause death
Measured: Event driven; Up to 38 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of 4-point MACE (CV death, MI, stroke, and hospitalisation for HF)
Time to first occurrence of any of the components of the composite of:
- CV death
- MI
- Stroke
- Hospitalisation for HF
Measured: Event driven; Up to 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start14 Mar 2025
- Primary completion17 Dec 2029 (estimated)
- Study completion17 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677060
- Sponsor's protocol ID
- D6973C00001
- Other IDs
- 2024-514506-32-00
- Acronym
- Prevent-HF
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2024
- Last updated
- 21 Oct 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
Dwyer 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