DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension
- Registration Number
- NCT00330369
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Darusentan 100 mg Darusentan Placebo Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks Darusentan Placebo Darusentan Placebo Placebo 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 Darusentan Placebo Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks Darusentan 300 mg Darusentan Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks Darusentan 300 mg Darusentan Placebo Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks Darusentan 50 mg Darusentan Placebo 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 Darusentan Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks
- Primary Outcome Measures
Name Time Method Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry Baseline to Week 14
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (114)
CAMC Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
Innovative Clinical Trials
🇺🇸San Antonio, Texas, United States
Deerfield Beach Cardiology Associates
🇺🇸Deerfield Beach, Florida, United States
White-Wilson Medical Center
🇺🇸Fort Walton Beach, Florida, United States
Connecticut Clinical Research, LLC
🇺🇸Bridgeport, Connecticut, United States
Chrishard Medical Group
🇺🇸Inglewood, California, United States
Apex Research Institute
🇺🇸Santa Ana, California, United States
Jacksonville Center for Clinical
🇺🇸Jacksonville, Florida, United States
Cardiovascular Center of Sarasota
🇺🇸Sarasota, Florida, United States
VA Medical Center - WLA
🇺🇸Los Angeles, California, United States
Castlerock Clinical Research Consultants
🇺🇸Tulsa, Oklahoma, United States
Hospital San Roque
🇦🇷Cordoba, Argentina
International Research Association
🇺🇸Miami, Florida, United States
Comprehensive Heart Failure Center
🇺🇸Mobile, Alabama, United States
Hospital Britanico de Buenos Aires
🇦🇷Buenos Aires, Argentina
Physicians East, PA
🇺🇸Greenville, North Carolina, United States
Northeast Clinical Research Centers, Inc.
🇺🇸Allentown, Pennsylvania, United States
Fundapres
🇦🇷Buenos Aires, Argentina
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
Heritage Cardiology Associates
🇺🇸Camp Hill, Pennsylvania, United States
Hospital Socor
🇧🇷Belo Horizonte, Brazil
CIMEL
🇦🇷Buenos Aires, Argentina
Cardiovascular Consultants of Maine
🇺🇸Scarborough, Maine, United States
Brandywine Clinical Research
🇺🇸Downingtown, Pennsylvania, United States
Pri-Med Care
🇺🇸Lewisville, Texas, United States
DIM (Clinica Privada)
🇦🇷Buenos Aires, Argentina
CHU la Timone Service de cardiologie
🇫🇷Marseille Cedex, France
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Bispebjerg Hospital
🇩🇰København, Denmark
COR Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
UAB Hypertension Program
🇺🇸Birmingham, Alabama, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Complete Renal Care
🇺🇸Denver, Colorado, United States
Centro Integrado Hospital do Rim e Hipertensao
🇧🇷Sao Paulo, Brazil
Hospital das Clinicas
🇧🇷Goiânia, Brazil
Instituto de Molestias
🇧🇷São José do Rio Preto, Brazil
AMK Research
🇺🇸Gainsville, Florida, United States
Tampa Bay Nephrology
🇺🇸Tampa, Florida, United States
Ricardo A. Bedoya, Cardiology
🇺🇸Jupiter, Florida, United States
A.G.A. Clinical Trials
🇺🇸Hialeah, Florida, United States
Global Research Partners
🇺🇸Calhoun, Georgia, United States
Chicago Heart & Vein Clinic
🇺🇸Elk Grove Village, Illinois, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
West Coast Cardiology Associates
🇺🇸Fairview Park, Ohio, United States
Green and Seidner Family Practice Associates
🇺🇸Lansdale, Pennsylvania, United States
RI Hospital
🇺🇸Providence, Rhode Island, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
T&R Clinical, P.A.
🇺🇸Ft Worth, Texas, United States
Texas Tech University Health Sciences Center
🇺🇸Lubbock, Texas, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
American Clinical Research LLC
🇺🇸Marrero, Louisiana, United States
Midwest Heart Foundation
🇺🇸Lombard, Illinois, United States
Medical Research Institute
🇺🇸Slidell, Louisiana, United States
Professional Clinical Research
🇺🇸Interlochen, Michigan, United States
Rockville Internal Medicine Group
🇺🇸Rockville, Maryland, United States
Hillsboro Cardiology, PC
🇺🇸Hillsboro, Oregon, United States
Neem Research Group, Inc.
🇺🇸Columbia, South Carolina, United States
Internal Medicine & Industrial Medicine
🇺🇸Desoto, Texas, United States
Peninsula Inernal Medicine
🇺🇸Gig Harbor, Washington, United States
Diabetes Center of the Southwest
🇺🇸Midland, Texas, United States
Burke Internal Medicine, Inc.
🇺🇸Burke, Virginia, United States
Liberty Research Center
🇺🇸Tacoma, Washington, United States
The Bracane Company
🇺🇸Plano, Texas, United States
Medeos
🇦🇷Buenos Aires, Argentina
Hospital Jose Maria Ramos Meijia
🇦🇷Buenos Aires, Argentina
Hospital Municipal bernardo Houssay
🇦🇷Buenos Aires, Argentina
CIC Hopital Jeanne D'Arc
🇫🇷Dommartin les Toul, France
Clinica Chutro SRL
🇦🇷Cordoba, Argentina
Sanatorio Municipal Dr. Julio Mendez
🇦🇷Buenos Aires, Argentina
Hospital de Clinicas da Universidade Federal do Parana
🇧🇷Curitiba, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
🇧🇷Sao Paulo, Brazil
Hospital Governador Israel Pinheiro
🇧🇷Belo Horizonte, Brazil
Centro Medico de Campinas
🇧🇷Campinas, Brazil
Centro integrado hospital
🇧🇷Sao Paulo, Brazil
Clinica de Exames
🇧🇷Maceió, Brazil
Clinical Research Solutions
🇨🇦Kitchener, Ontario, Canada
Cambridge Cardiac Care Center
🇨🇦Cambridge, Ontario, Canada
CHU de Grenoble
🇫🇷Grenoble Cedex, France
CHU Victor Provo
🇫🇷Roubaix, France
Hôpital Civil, Service HTA maladies vasculaires
🇫🇷Strasbourg Cedex, France
St Josefs-Hospital
🇩🇪Cloppenburg, Germany
Charité Campus Buch
🇩🇪Berlin, Germany
Kerckhoff-Klinik Forschungs GmbH
🇩🇪Bad Nauheim, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Fundacio Puigvert
🇪🇸Barcelona, Spain
Azienda Ospedaliera University of Padua Policlinico
🇮🇹Padua, Italy
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario de Santiago
🇪🇸Coruña, Spain
Hospital Clínico de San Carlos
🇪🇸Madrid, Spain
Hospital Clínico San Cecilio
🇪🇸Granada, Spain
Hospital Universitario 12 de Octobre
🇪🇸Madrid, Spain
Hospital Carlos Haya
🇪🇸Malaga, Spain
Avenue Surgery
🇬🇧Wiltshire, United Kingdom
Cardiovascular Research, Karolinska Institue
🇸🇪Stockholm, Sweden
Stonehill Medical Centre
🇬🇧Bolton,, United Kingdom
Townhead Surgery
🇬🇧Scotland, United Kingdom
Hathaway Medical Centre
🇬🇧Wiltshire, United Kingdom
Southwest Cardiology Associates
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Investigation Specialists, Inc.
🇺🇸Gurnee, Illinois, United States
Nephrology and Hypertension / Hurley Medical Center
🇺🇸Flint, Michigan, United States
Sacramento Heart and Vascular
🇺🇸Sacramento, California, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
MODEL Clinical Research
🇺🇸Baltimore, Maryland, United States
Maryland Medical Research/Og Medical Center
🇺🇸Oxon Hill, Maryland, United States
Maine Research Associates
🇺🇸Auburn, Maine, United States
Clinical Associates
🇺🇸Reisterstown, Maryland, United States
Canyon Clinical Research
🇺🇸Tucson, Arizona, United States
MedStar Diabetes Institute at Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Specialty Medical Center
🇺🇸Pahrump, Nevada, United States
Kula Research
🇺🇸Honolulu, Hawaii, United States
Bronx VA Medical Center / Mt. Sinai
🇺🇸Bronx, New York, United States