DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
- Registration Number
- NCT00353574
- 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 United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 282
- Subjects who have completed the Treatment Period of clinical trial DAR-311
- Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
- Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related adverse event (AE)
- Treatment with another endothelin receptor antagonist within 6 months of study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Darusentan 50 mg Darusentan Darusentan 50 mg administered orally once daily Darusentan 100 mg Darusentan Darusentan 100 mg administered orally once daily Darusentan 300 mg Darusentan Darusentan 300 mg administered orally once daily
- Primary Outcome Measures
Name Time Method Change in trough sitting systolic and diastolic blood pressure Baseline to Week 14
- Secondary Outcome Measures
Name Time Method Change in mean 24-hour systolic and diastolic ambulatory blood pressures. Baseline to Week 14 Percentage of subjects who reach systolic blood pressure goal Week 14 Change in estimated glomerular filtration rate (eGFR) Baseline to Week 14
Trial Locations
- Locations (74)
Apex Research Institute
🇺🇸Santa Ana, California, United States
Cardiovascular Center of Sarasota
🇺🇸Sarasota, Florida, United States
Castlerock Clinical Research Consultants
🇺🇸Tulsa, Oklahoma, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
International Research Association
🇺🇸Miami, Florida, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Bispebjerg Hospital
🇩🇰København, Denmark
Complete Renal Care
🇺🇸Denver, Colorado, United States
Townhead Surgery
🇬🇧Scotland, United Kingdom
Avenue Surgery
🇬🇧Wiltshire, United Kingdom
Heritage Cardiology Associates
🇺🇸Camp Hill, Pennsylvania, United States
CIC Hopital Jeanne D'Arc
🇫🇷Dommartin les Toul, France
COR Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Burke Internal Medicine, Inc.
🇺🇸Burke, Virginia, United States
Hospital Jose Maria Ramos Meijia
🇦🇷Buenos Aires, Argentina
Connecticut Clinical Research, LLC
🇺🇸Bridgeport, Connecticut, United States
Chicago Heart & Vein Clinic
🇺🇸Elk Grove Village, Illinois, United States
Internal Medicine & Industrial Medicine
🇺🇸Desoto, Texas, United States
CIMEL
🇦🇷Buenos Aires, Argentina
Fundapres
🇦🇷Buenos Aires, Argentina
Hathaway Medical Centre
🇬🇧Wiltshire, United Kingdom
Androscoggin Cardiology Associates
🇺🇸Auburn, Maine, United States
Clinical Associates
🇺🇸Reisterstown, Maryland, United States
Hillsboro Cardiology, PC
🇺🇸Hillsboro, Oregon, United States
Cardiovascular Research, Karolinska Institue
🇸🇪Stockholm, Sweden
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
Centro Integrado Hospital do Rim e Hipertensao
🇧🇷Sao Paulo, Brazil
RI Hospital
🇺🇸Providence, Rhode Island, United States
Liberty Research Center
🇺🇸Tacoma, Washington, United States
White-Wilson Medical Center
🇺🇸Fort Walton Beach, Florida, United States
Cambridge Cardiac Care Center
🇨🇦Cambridge, Ontario, Canada
Brandywine Clinical Research
🇺🇸Downingtown, Pennsylvania, United States
University Hospital Umea
🇸🇪Umea, Sweden
Cardiovascular Consultants of Maine
🇺🇸Scarborough, Maine, United States
VA Medical Center - WLA
🇺🇸Los Angeles, California, United States
Medical Research Institute
🇺🇸Slidell, Louisiana, United States
Specialty Medical Center
🇺🇸Pahrump, Nevada, United States
Chrishard Medical Group
🇺🇸Inglewood, California, United States
Clinical Investigation Specialists, Inc.
🇺🇸Gurnee, Illinois, United States
Comprehensive Heart Failure Center
🇺🇸Mobile, Alabama, United States
Canyon Clinical Research
🇺🇸Tucson, Arizona, United States
Global Research Partners
🇺🇸Calhoun, Georgia, United States
Rockville Internal Medicine Group
🇺🇸Rockville, Maryland, United States
T&R Clinical, P.A.
🇺🇸Ft Worth, Texas, United States
Midwest Heart Foundation
🇺🇸Lombard, Illinois, United States
Hospital Britanico de Buenos Aires
🇦🇷Buenos Aires, Argentina
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
CHU de Grenoble
🇫🇷Grenoble Cedex, France
Professional Clinical Research
🇺🇸Interlochen, Michigan, United States
Sanatorio Municipal
🇦🇷Buenos Aires, Argentina
Tampa Bay Nephrology Associates, PL
🇺🇸Tampa, Florida, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Innovative Clinical Trials
🇺🇸San Antonio, Texas, United States
Green and Seidner Family Practice Associates
🇺🇸Lansdale, Pennsylvania, United States
MedStar Diabetes Institute at Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Jacksonville Center for Clinical
🇺🇸Jacksonville, Florida, United States
A.G.A. Clinical Trials
🇺🇸Hialeah, Florida, United States
Ricardo A. Bedoya, Cardiology
🇺🇸Jupiter, Florida, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Southwest Cardiology Associates
🇺🇸Oklahoma City, Oklahoma, United States
Northeast Clinical Research Centers, Inc.
🇺🇸Allentown, Pennsylvania, United States
Neem Research Group, Inc.
🇺🇸Columbia, South Carolina, United States
DIM (Clinica Privada)
🇦🇷Buenos Aires, Argentina
Hospital Municipal Bernardo Houssay
🇦🇷Buenos Aires, Argentina
Medeos
🇦🇷Buenos Aires, Argentina
Centro Integrado Hospital
🇧🇷Sao Paulo, Brazil
Hôpital Civil, Service HTA maladies vasculaires
🇫🇷Strasbourg Cedex, France
Clinical Research Solutions
🇨🇦Kitchener, Ontario, Canada
Kula Research
🇺🇸Honolulu, Hawaii, United States
Maine Research Associate
🇺🇸Auburn, Maine, United States
Physicians East, PA
🇺🇸Greenville, North Carolina, United States
Pri-Med Care
🇺🇸Lewisville, Texas, United States
Sacramento Heart and Vascular
🇺🇸Sacramento, California, United States