HypertensionPhase 3NCT00330369
DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension
A Phase 3 study testing Darusentan in people with Hypertension, run by Gilead Sciences at 115 sites in 11 countries.
Trial summary
This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the U.S. Food and Drug Administration (FDA) for use in the United States, which means that a doctor cannot prescribe this drug. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Darusentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 115 sitesin 11 countries
- Study dates
- Jun 2006to Jan 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are competent to provide written consent
- Aged 35 to 80 years
- Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmHg
- All other subjects must have a mean systolic blood pressure ≥140 mmHg
- Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
- Female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)
Who cannot join
- Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- Serum ALT or AST >2 x the upper limit of the normal range (ULN)
- Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (CVA) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
- Implanted pacemakers or implanted cardioverter defibrillator (ICD)
- Symptomatic congestive heart failure requiring treatment
- Hemodynamically significant valvular heart disease
Show all 12Show fewer
- Type I diabetes mellitus
- Hemodialysis or peritoneal dialysis; or history of renal transplant
- Diagnosis or recurrence of malignancy within the past 3 years
- Sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90%
- Subjects who perform alternating shift or night work
- Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening
Trial locations and contacts
115 sites in 11 countries.
115 sites in 11 countries
United States67 sites
Northeast Clinical Research Centers, Inc.
Allentown, Pennsylvania, 18103
Maine Research Associates
Auburn, Maine, 04210
MODEL Clinical Research
Baltimore, Maryland, 21204
Professional Clinical Research
Benzonia, Michigan, 49616
UAB Hypertension Program
Birmingham, Alabama, 35294
Connecticut Clinical Research, LLC
Bridgeport, Connecticut, 06606
Burke Internal Medicine, Inc.
Burke, Virginia, 22015
Global Research Partners
Calhoun, Georgia, 30701
Heritage Cardiology Associates
Camp Hill, Pennsylvania, 17011
CAMC Clinical Trials Center
Charleston, West Virginia, 25304
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
Neem Research Group, Inc.
Columbia, South Carolina, 29201
Deerfield Beach Cardiology Associates
Deerfield Beach, Florida, 33442
Complete Renal Care
Denver, Colorado, 80220
Internal Medicine & Industrial Medicine
DeSoto, Texas, 75115
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335
Chicago Heart & Vein Clinic
Elk Grove Village, Illinois, 60007
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
West Coast Cardiology Associates
Fairview Park, Ohio, 44125
Nephrology and Hypertension / Hurley Medical Center
Flint, Michigan, 48503
White-Wilson Medical Center
Fort Walton Beach, Florida, 32569
T&R Clinical, P.A.
Fort Worth, Texas, 76117
AMK Research
Gainsville, Florida, 32601
Peninsula Inernal Medicine
Gig Harbor, Washington, 98335
Physicians East, PA
Greenville, North Carolina, 27834
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031
A.G.A. Clinical Trials
Hialeah, Florida, 33012
Hillsboro Cardiology, PC
Hillsboro, Oregon, 97123
Kula Research
Honolulu, Hawaii, 96816
Chrishard Medical Group
Inglewood, California, 90301
Professional Clinical Research
Interlochen, Michigan, 49643
Jacksonville Center for Clinical
Jacksonville, Florida, 32216
Ricardo A. Bedoya, Cardiology
Jupiter, Florida, 33458
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, 19446
Pri-Med Care
Lewisville, Texas, 75067
Midwest Heart Foundation
Lombard, Illinois, 60148
VA Medical Center - WLA
Los Angeles, California, 90073
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Manassas Clinical Research Center
Manassas, Virginia, 20110
American Clinical Research LLC
Marrero, Louisiana, 70072
International Research Association
Miami, Florida, 33156
Diabetes Center of the Southwest
Midland, Texas, 79705
Comprehensive Heart Failure Center
Mobile, Alabama, 36608
COR Clinical Research
Oklahoma City, Oklahoma, 73003
Southwest Cardiology Associates
Oklahoma City, Oklahoma, 73109
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
Maryland Medical Research/Og Medical Center
Oxon Hill, Maryland, 20745
Specialty Medical Center
Pahrump, Nevada, 89048
Temple University Hospital
Philadelphia, Pennsylvania, 19140
The Bracane Company
Plano, Texas, 75093
RI Hospital
Providence, Rhode Island, 02903
Clinical Associates
Reisterstown, Maryland, 21136
McGuire VA Medical Center
Richmond, Virginia, 22015
Rockville Internal Medicine Group
Rockville, Maryland, 20854
Sacramento Heart and Vascular
Sacramento, California, 95825
Innovative Clinical Trials
San Antonio, Texas, 78229
Apex Research Institute
Santa Ana, California, 92705
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239
Cardiovascular Consultants of Maine
Scarborough, Maine, 04074
Medical Research Institute
Slidell, Louisiana, 70458
Liberty Research Center
Tacoma, Washington, 98405
Tampa Bay Nephrology
Tampa, Florida, 33603
Bronx VA Medical Center / Mt. Sinai
The Bronx, New York, 10468
Canyon Clinical Research
Tucson, Arizona, 85712
Castlerock Clinical Research Consultants
Tulsa, Oklahoma, 74136
MedStar Diabetes Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
Argentina10 sites
CIMEL
Buenos Aires
DIM (Clinica Privada)
Buenos Aires
Fundapres
Buenos Aires
Hospital Britanico de Buenos Aires
Buenos Aires
Hospital Jose Maria Ramos Meijia
Buenos Aires
Hospital Municipal bernardo Houssay
Buenos Aires
Medeos
Buenos Aires
Sanatorio Municipal Dr. Julio Mendez
Buenos Aires
Clinica Chutro SRL
Córdoba
Hospital San Roque
Córdoba
Brazil10 sites
Hospital Governador Israel Pinheiro
Belo Horizonte
Hospital Socor
Belo Horizonte
Centro Medico de Campinas
Campinas
Hospital de Clinicas da Universidade Federal do Parana
Curitiba
Hospital das Clinicas
Goiânia
Clinica de Exames
Maceió
Instituto de Molestias
São José do Rio Preto
Centro Integrado Hospital do Rim e Hipertensao
São Paulo
Centro integrado hospital
São Paulo
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo
Spain8 sites
Hospital Universitario de Santiago
A Coruña
Fundacio Puigvert
Barcelona
Hospital Clinic i Provincial
Barcelona
Hospital del Mar
Barcelona
Hospital Clínico San Cecilio
Granada
Hospital Clínico de San Carlos
Madrid
Hospital Universitario 12 de Octobre
Madrid
Hospital Carlos Haya
Málaga
France5 sites
CIC Hopital Jeanne D'Arc
Dommartin-lès-Toul
CHU de Grenoble
Grenoble
CHU la Timone Service de cardiologie
Marseille
CHU Victor Provo
Roubaix
Hôpital Civil, Service HTA maladies vasculaires
Strasbourg
Germany5 sites
Kerckhoff-Klinik Forschungs GmbH
Bad Nauheim
Charité Campus Buch
Berlin
St Josefs-Hospital
Cloppenburg
Medizinische Hochschule Hannover
Hanover
Universitätsklinikum Schleswig-Holstein
Lübeck
United Kingdom4 sites
Stonehill Medical Centre
Bolton
Townhead Surgery
Scotland
Avenue Surgery
Wiltshire
Hathaway Medical Centre
Wiltshire
Canada2 sites
Cambridge Cardiac Care Center
Cambridge, Ontario, N3H 3R8
Clinical Research Solutions
Kitchener, Ontario, N2G 1G5
About this study
Official title: DORADO - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311)
This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the U.S. Food and Drug Administration (FDA) for use in the United States, which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of three or more antihypertensive drugs, including a diuretic.
- Conditions
- Hypertension
- Being tested
- Darusentan, Darusentan Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarusentanDrug
Also called LU 135252
Darusentan administered orally once daily
Darusentan PlaceboDrug
Placebo to match darusentan administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Darusentan Placebo | Placebo comparator | Placebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks Receives: Drug: Darusentan Placebo |
| Darusentan 50 mg | Experimental | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks Receives: Drug: Darusentan; Drug: Darusentan Placebo |
| Darusentan 100 mg | Experimental | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks Receives: Drug: Darusentan; Drug: Darusentan Placebo |
| Darusentan 300 mg | Experimental | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks Receives: Drug: Darusentan; Drug: Darusentan Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry
Measured: Baseline to Week 14
Secondary outcomes (3)
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
Measured: Baseline to Week 14
Percentage of subjects to reach systolic blood pressure goal
Measured: Week 14
Change from baseline in estimated glomerular filtration rate (eGFR)
Measured: Baseline to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2009
- Study completionJan 2009
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 HypertensionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330369
- Sponsor's protocol ID
- DAR-311
- Status last verified
- Feb 2014
- First submitted
- 24 May 2006
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weber MA, Black H, Bakris G, Krum H, Linas S, Weiss R, Linseman JV, Wiens BL, Warren MS, Lindholm LH. A selective endothelin-receptor antagonist to reduce blood pressure in patients with treatment-resistant hypertension: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Oct 24;374(9699):1423-31. doi: 10.1016/S0140-6736(09)61500-2. Epub 2009 Sep 11.
PubMed 19748665
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DORADO - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311)
- ClinicalTrials.gov ID
- NCT00330369
- Acronym / sponsor ID
- DAR-311
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 26 May 2006 (estimated)
- 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.
This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the U.S. Food and Drug Administration (FDA) for use in the United States, which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of three or more antihypertensive drugs, including a diuretic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Darusentan Placebo | Placebo comparator | Drug: Darusentan PlaceboPlacebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks |
| Darusentan 50 mg | Experimental | Drug: Darusentan, Drug: Darusentan PlaceboPlacebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks |
| Darusentan 100 mg | Experimental | Drug: Darusentan, Drug: Darusentan PlaceboPlacebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks |
| Darusentan 300 mg | Experimental | Drug: Darusentan, Drug: Darusentan PlaceboPlacebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who are competent to provide written consent
- Aged 35 to 80 years
- Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmHg
- All other subjects must have a mean systolic blood pressure ≥140 mmHg
- Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
Key exclusion criteria (12 listed)
- Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- Serum ALT or AST >2 x the upper limit of the normal range (ULN)
- Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (CVA) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
- Implanted pacemakers or implanted cardioverter defibrillator (ICD)
- Symptomatic congestive heart failure requiring treatment
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 |
|---|---|---|
| DarusentanAlso: LU 135252Darusentan administered orally once daily | Drug | Darusentan 100 mg, Darusentan 300 mg, Darusentan 50 mg |
| Darusentan PlaceboPlacebo to match darusentan administered orally once daily | Drug | Darusentan 100 mg, Darusentan 300 mg, Darusentan 50 mg, Darusentan Placebo |
Primary outcome
Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry
Time frame: Baseline to Week 14
3 secondary outcomes
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
Time frame: Baseline to Week 14
Percentage of subjects to reach systolic blood pressure goal
Time frame: Week 14
Change from baseline in estimated glomerular filtration rate (eGFR)
Time frame: Baseline to Week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Derived from this study: PubMed 19748665Weber MA, Black H, Bakris G, Krum H, Linas S, Weiss R, Linseman JV, Wiens BL, Warren MS, Lindholm LH. A selective endothelin-receptor antagonist to reduce blood pressure in patients with treatment-resistant hypertension: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Oct 24;374(9699):1423-31. doi: 10.1016/S0140-6736(09)61500-2. Epub 2009 Sep 11.
- Related InfoLink provided by the sponsor.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
115 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darusentan in people with Hypertension, run by Gilead Sciences at 115 sites in 11 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in United States, Argentina, Brazil, Spain, France and 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry (time frame: Baseline to Week 14). 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 NCT00330369, which also lists 1 linked publication.
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 18 Mar 2014.