DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension
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)
1 other identifier
interventional
352
11 countries
115
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started Jun 2006
Typical duration for phase_3 hypertension
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2006
CompletedFirst Posted
Study publicly available on registry
May 26, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedMarch 18, 2014
February 1, 2014
2.6 years
May 24, 2006
February 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry
Baseline to Week 14
Secondary Outcomes (3)
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
Baseline to Week 14
Percentage of subjects to reach systolic blood pressure goal
Week 14
Change from baseline in estimated glomerular filtration rate (eGFR)
Baseline to Week 14
Study Arms (4)
Darusentan Placebo
PLACEBO COMPARATORPlacebo 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
EXPERIMENTALPlacebo 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
EXPERIMENTALPlacebo 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
EXPERIMENTALPlacebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks
Interventions
Darusentan administered orally once daily
Placebo to match darusentan administered orally once daily
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (115)
UAB Hypertension Program
Birmingham, Alabama, 35294, United States
Comprehensive Heart Failure Center
Mobile, Alabama, 36608, United States
Canyon Clinical Research
Tucson, Arizona, 85712, United States
Chrishard Medical Group
Inglewood, California, 90301, United States
VA Medical Center - WLA
Los Angeles, California, 90073, United States
Sacramento Heart and Vascular
Sacramento, California, 95825, United States
Apex Research Institute
Santa Ana, California, 92705, United States
Complete Renal Care
Denver, Colorado, 80220, United States
Connecticut Clinical Research, LLC
Bridgeport, Connecticut, 06606, United States
MedStar Diabetes Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Deerfield Beach Cardiology Associates
Deerfield Beach, Florida, 33442, United States
White-Wilson Medical Center
Fort Walton Beach, Florida, 32569, United States
AMK Research
Gainsville, Florida, 32601, United States
A.G.A. Clinical Trials
Hialeah, Florida, 33012, United States
Jacksonville Center for Clinical
Jacksonville, Florida, 32216, United States
Ricardo A. Bedoya, Cardiology
Jupiter, Florida, 33458, United States
International Research Association
Miami, Florida, 33156, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239, United States
Tampa Bay Nephrology
Tampa, Florida, 33603, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Global Research Partners
Calhoun, Georgia, 30701, United States
Kula Research
Honolulu, Hawaii, 96816, United States
Chicago Heart & Vein Clinic
Elk Grove Village, Illinois, 60007, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031, United States
Midwest Heart Foundation
Lombard, Illinois, 60148, United States
American Clinical Research LLC
Marrero, Louisiana, 70072, United States
Medical Research Institute
Slidell, Louisiana, 70458, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Cardiovascular Consultants of Maine
Scarborough, Maine, 04074, United States
MODEL Clinical Research
Baltimore, Maryland, 21204, United States
Maryland Medical Research/Og Medical Center
Oxon Hill, Maryland, 20745, United States
Clinical Associates
Reisterstown, Maryland, 21136, United States
Rockville Internal Medicine Group
Rockville, Maryland, 20854, United States
Professional Clinical Research
Benzonia, Michigan, 49616, United States
Nephrology and Hypertension / Hurley Medical Center
Flint, Michigan, 48503, United States
Professional Clinical Research
Interlochen, Michigan, 49643, United States
Specialty Medical Center
Pahrump, Nevada, 89048, United States
Bronx VA Medical Center / Mt. Sinai
The Bronx, New York, 10468, United States
Physicians East, PA
Greenville, North Carolina, 27834, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
West Coast Cardiology Associates
Fairview Park, Ohio, 44125, United States
COR Clinical Research
Oklahoma City, Oklahoma, 73003, United States
Southwest Cardiology Associates
Oklahoma City, Oklahoma, 73109, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Castlerock Clinical Research Consultants
Tulsa, Oklahoma, 74136, United States
Hillsboro Cardiology, PC
Hillsboro, Oregon, 97123, United States
Northeast Clinical Research Centers, Inc.
Allentown, Pennsylvania, 18103, United States
Heritage Cardiology Associates
Camp Hill, Pennsylvania, 17011, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335, United States
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, 19446, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
RI Hospital
Providence, Rhode Island, 02903, United States
Neem Research Group, Inc.
Columbia, South Carolina, 29201, United States
Internal Medicine & Industrial Medicine
DeSoto, Texas, 75115, United States
T&R Clinical, P.A.
Fort Worth, Texas, 76117, United States
Pri-Med Care
Lewisville, Texas, 75067, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Diabetes Center of the Southwest
Midland, Texas, 79705, United States
The Bracane Company
Plano, Texas, 75093, United States
Innovative Clinical Trials
San Antonio, Texas, 78229, United States
Burke Internal Medicine, Inc.
Burke, Virginia, 22015, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
McGuire VA Medical Center
Richmond, Virginia, 22015, United States
Peninsula Inernal Medicine
Gig Harbor, Washington, 98335, United States
Liberty Research Center
Tacoma, Washington, 98405, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
CIMEL
Buenos Aires, Argentina
DIM (Clinica Privada)
Buenos Aires, Argentina
Fundapres
Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina
Hospital Jose Maria Ramos Meijia
Buenos Aires, Argentina
Hospital Municipal bernardo Houssay
Buenos Aires, Argentina
Medeos
Buenos Aires, Argentina
Sanatorio Municipal Dr. Julio Mendez
Buenos Aires, Argentina
Clinica Chutro SRL
Córdoba, Argentina
Hospital San Roque
Córdoba, Argentina
Hospital Governador Israel Pinheiro
Belo Horizonte, Brazil
Hospital Socor
Belo Horizonte, Brazil
Centro Medico de Campinas
Campinas, Brazil
Hospital de Clinicas da Universidade Federal do Parana
Curitiba, Brazil
Hospital das Clinicas
Goiânia, Brazil
Clinica de Exames
Maceió, Brazil
Instituto de Molestias
São José do Rio Preto, Brazil
Centro Integrado Hospital do Rim e Hipertensao
São Paulo, Brazil
Centro integrado hospital
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, Brazil
Cambridge Cardiac Care Center
Cambridge, Ontario, N3H 3R8, Canada
Clinical Research Solutions
Kitchener, Ontario, N2G 1G5, Canada
Bispebjerg Hospital
Copenhagen, Denmark
Hvidovre Hospital
Hvidovre, Denmark
CIC Hopital Jeanne D'Arc
Dommartin-lès-Toul, France
CHU de Grenoble
Grenoble, France
CHU la Timone Service de cardiologie
Marseille, France
CHU Victor Provo
Roubaix, France
Hôpital Civil, Service HTA maladies vasculaires
Strasbourg, France
Kerckhoff-Klinik Forschungs GmbH
Bad Nauheim, Germany
Charité Campus Buch
Berlin, Germany
St Josefs-Hospital
Cloppenburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Azienda Ospedaliera University of Padua Policlinico
Padua, Italy
Hospital Universitario de Santiago
A Coruña, Spain
Fundacio Puigvert
Barcelona, Spain
Hospital Clinic i Provincial
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Clínico San Cecilio
Granada, Spain
Hospital Clínico de San Carlos
Madrid, Spain
Hospital Universitario 12 de Octobre
Madrid, Spain
Hospital Carlos Haya
Málaga, Spain
Cardiovascular Research, Karolinska Institue
Stockholm, Sweden
Stonehill Medical Centre
Bolton, United Kingdom
Townhead Surgery
Scotland, United Kingdom
Avenue Surgery
Wiltshire, United Kingdom
Hathaway Medical Centre
Wiltshire, United Kingdom
Related Publications (1)
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.
PMID: 19748665DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2006
First Posted
May 26, 2006
Study Start
June 1, 2006
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
March 18, 2014
Record last verified: 2014-02