DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
- Registration Number
- NCT00389675
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 661
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Darusentan Darusentan Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily Guanfacine Guanfacine Guanfacine 1 mg capsules administered orally once daily
- Primary 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 who reach systolic blood pressure goal Week 14 Change from baseline in estimated glomerular filtration rate (eGFR) Baseline to Week 14
- Secondary Outcome Measures
Name Time Method Change from baseline in trough sitting systolic and diastolic blood pressures Baseline to Week 14
Trial Locations
- Locations (97)
Arkansas Primary Care Clinic, PA
🇺🇸Little Rock, Arkansas, United States
Medical Investigators, Inc.
🇺🇸Little Rock, Arkansas, United States
St John's Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Internal Medicine of Northern Michigan
🇺🇸Petoskey, Michigan, United States
Glacier View Cardiology, PC
🇺🇸Kalispell, Montana, United States
New Jersey Physicians
🇺🇸Passaic, New Jersey, United States
Internal Medicine of Greer
🇺🇸Greer, South Carolina, United States
Fletcher Allen Health Care/University of Vermont
🇺🇸Burlington, Vermont, United States
Policlinica Bancaria "9 de Julio"
🇦🇷Buenos Aires, Argentina
Instituto de Cardiologia de Corrientes
🇦🇷Corrientes, Argentina
Framingham Centro Medico
🇦🇷La Plata, Argentina
Instituto de Investigaciones Clinicas de Quilmes
🇦🇷Quilmes, Argentina
NEA Clinical
🇺🇸Jonesboro, Arkansas, United States
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Atlanta Vascular Research Foundation
🇺🇸Tucker, Georgia, United States
Salim Gopalani, MD, PA
🇺🇸Houston, Texas, United States
Humayum Mirza, MD, PA
🇺🇸Houston, Texas, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
WVU Physicicans of Charleston
🇺🇸Charleston, West Virginia, United States
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, United States
A + Research Inc.
🇺🇸Miami, Florida, United States
Alabama Internal Medicine, PC
🇺🇸Birmingham, Alabama, United States
Greystone Medical Research, LLC
🇺🇸Birmingham, Alabama, United States
Lovelace Scientific Resource, Inc.
🇺🇸Phoenix, Arizona, United States
Aurora Denver Cardiology Associates
🇺🇸Denver, Colorado, United States
The Heart Center, PC
🇺🇸Huntsville, Alabama, United States
Houston Clinical Research Assoc.
🇺🇸Houston, Texas, United States
Minneapolis VAMC
🇺🇸Minneapolis, Minnesota, United States
Lifeline Research Institute
🇺🇸Brooklyn, New York, United States
Heart Care Center of Charlotte
🇺🇸Charlotte, North Carolina, United States
Physicians East, PA
🇺🇸Winterville, North Carolina, United States
Castlerock Clinical Research Consultants, LLC
🇺🇸Tulsa, Oklahoma, United States
Southeast Texas Clinical Research Center
🇺🇸Beaumont, Texas, United States
Central Minnesota Heart Center at St. Cloud Hospital
🇺🇸St. Cloud, Minnesota, United States
Cardiovascular Consultants, Ltd.
🇺🇸Glendale, Arizona, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
St. Paul Cardiology
🇺🇸St. Paul, Minnesota, United States
Internal Medicine Associates of South Florida
🇺🇸N. Miami Beach, Florida, United States
Great Lakes Heart Center of Alpena
🇺🇸Alpena, Michigan, United States
Louisiana Research Associates, Inc.
🇺🇸New Orleans, Louisiana, United States
Maine Research Associates
🇺🇸Auburn, Maine, United States
PrimeCare Internal Medicine
🇺🇸Biddeford, Maine, United States
Integrated Medical Research PC
🇺🇸Ashland, Oregon, United States
Cardiovascular Research Inst. of Dallas
🇺🇸Dallas, Texas, United States
Plaza Medical Group, PC
🇺🇸Oklahoma City, Oklahoma, United States
Metrolina Internal Medicine, PA
🇺🇸Charlotte, North Carolina, United States
Charleston Cardiology
🇺🇸Charleston, South Carolina, United States
NJ Heart
🇺🇸Linden, New Jersey, United States
Scenic City Research
🇺🇸Cleveland, Tennessee, United States
Sergio F Rovner, MD
🇺🇸El Paso, Texas, United States
Flinders Medical Centre
🇦🇺Bedford, Australia
Centro de Investigaciones clincas de Litoral
🇦🇷Santa Fe, Argentina
Private Practice of Dr. Herwig Van Aerde
🇧🇷Rio de Janeiro, Brazil
North Texas Medical Research
🇺🇸Plano, Texas, United States
Royal Perth Hospital
🇦🇺Perth, Australia
Mulberry Medical Associates, PC
🇺🇸Montgomery, Alabama, United States
Arizona Center for Clinical Research
🇺🇸Glendale, Arizona, United States
Southwest Heart
🇺🇸Tucson, Arizona, United States
Cochise Clinical Research
🇺🇸Sierra Vista, Arizona, United States
HealthFirst Physicians of AR, PA dba Convenient Care Clinic
🇺🇸Hot Springs, Arkansas, United States
Rancho Cucamonga Clinical Trials
🇺🇸Rancho Cucamonga, California, United States
Highgrove Medical Center
🇺🇸Bakersfield, California, United States
Central Cardiology Medical Clinic
🇺🇸Bakersfield, California, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Pacific Heart Institute
🇺🇸Santa Monica, California, United States
Los angeles biomedical research Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Doctors Medical center of Walton County
🇺🇸Defuniak Springs, Florida, United States
Maxine Hamilton, MD, PA
🇺🇸Ft Lauderdale, Florida, United States
AppleMed Research, Inc.
🇺🇸Miami, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
🇺🇸Ormond Beach, Florida, United States
Cardiovascular Center of Sarasota
🇺🇸Sarasota, Florida, United States
Suncoast Cardiovascular Research, Inc
🇺🇸St Petersburg, Florida, United States
Orlando Rangel, MD, PA
🇺🇸Tampa, Florida, United States
Private Practice of Dr. Bridget Bellingar
🇺🇸Largo, Florida, United States
Nothwest Florida Heart Group, PA-Research Dept
🇺🇸Pensacola, Florida, United States
Tampa Bay Nephrology Associates, PL
🇺🇸Tampa, Florida, United States
Consultants in Cardiovascular Med (CIS)
🇺🇸Melrose Park, Illinois, United States
AMR Research Associates, LLC
🇺🇸Bogart, Georgia, United States
Illinois Heart & Lunch Research Center
🇺🇸Normal, Illinois, United States
Methodist Medical Center-Heart, Lung & Vascular Institute
🇺🇸Peoria, Illinois, United States
Medical consultants, PC
🇺🇸Muncie, Indiana, United States
University Medical Associates
🇺🇸Louisville, Kentucky, United States
Dr. Jeffrey Chen
🇺🇸Lafayette, Louisiana, United States
Galenos Research
🇺🇸Dallas, Texas, United States
Blackstone Cardiology Associates
🇺🇸Pawtucket, Rhode Island, United States
Paris View Family Practice
🇺🇸Greenville, South Carolina, United States
Innovative Research of West Florida
🇺🇸Hurst, Texas, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Alpha Medical Research, LLC
🇺🇸Madison, Wisconsin, United States
Kamlesh N Dave Cardiology
🇺🇸Hopewell, Virginia, United States
Executive Health and Research Associates
🇺🇸Madison, Wisconsin, United States
Consultorios Medicos Privados S.A.
🇦🇷Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Bahia Blanca
🇦🇷Bahia Blanca, Argentina
MD Investigaciones
🇦🇷Ciudad de Buenos Aires, Argentina
Diabaid (Instituto de Asistencia Integral en Diabetes)
🇦🇷Ciudad de Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata
🇦🇷Mar del Plata, Argentina
Instituto de Investigaciones Clinicas
🇦🇷Rosario, Argentina