DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00389779
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. Darusentan is 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 determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose), an active comparator, or placebo, administered orally. The treatment period for this trial is 14 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 849
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Darusentan Darusentan Placebo Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily for 14 weeks Guanfacine Guanfacine Placebo to match darusentan for 2-week placebo run-in period, followed by guanfacine 1 mg capsules administered orally once daily for 14 weeks Guanfacine Darusentan Placebo Placebo to match darusentan for 2-week placebo run-in period, followed by guanfacine 1 mg capsules 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 Darusentan Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 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 Percentage of subjects reaching systolic blood pressure goal after 14 weeks of treatment Week 14 Change from baseline in mean 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) Baseline to Week 14 Change from baseline in estimated glomerular filtration rate (eGFR) Baseline to Week 14
Trial Locations
- Locations (145)
NEA Clinic
🇺🇸Jonesboro, Arkansas, United States
Cardiovascular Research Inst. of Dallas
🇺🇸Dallas, Texas, United States
Central Cardiology Medical Clinic
🇺🇸Bakersfield, California, United States
Suncoast Cardiovascular Research, Inc.
🇺🇸St. Petersburg, Florida, United States
Atlanta Vascular Research Foundation
🇺🇸Tucker, Georgia, United States
Cochise Clinical Research
🇺🇸Sierra Vista, Arizona, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Internal Medicine Associates of South Florida
🇺🇸N. Miami Beach, Florida, United States
Orlando Rangel, MD, PA
🇺🇸Tampa, Florida, United States
NJ Heart
🇺🇸Linden, New Jersey, United States
New Jersey Physicians
🇺🇸Passaic, New Jersey, United States
Glacier View Cardiology, PC
🇺🇸Kalispell, Montana, United States
Louisiana Research Associates, Inc
🇺🇸New Orleans, Louisiana, United States
Integrated Medical Research PC
🇺🇸Ashland, Oregon, United States
Instituto de Investigaciones Clinicas Bahia Blanca
🇦🇷Bahia Blanca, Buenos Aires, Argentina
Paris View Family Practice
🇺🇸Greenville, South Carolina, United States
Centro de Investigaciones Clinicas del Litoral
🇦🇷Santa Fe, Argentina
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Fletcher Allen Health Care/University of Vermont
🇺🇸Burlington, Vermont, United States
WVU Physicians of Charleston
🇺🇸Charleston, West Virginia, United States
Consultorios Medicos Privados S.A.
🇦🇷Buenos Aires, Argentina
Centro Medico Privado
🇦🇷Ciudad de, Argentina
Instituto de Investigaciones Clinicas de Quilmes
🇦🇷Quilmes, Argentina
Private Practice of Dr. Herman Docx
🇧🇪Hoeilaart, Belgium
Private Practice of Dr. Yohan Balthazar
🇧🇪Natoye, Belgium
Private Practice of Dr. Francis Vrancken
🇧🇪Genk, Belgium
Private Practice of Dr. Jean Gilissen
🇧🇪Riemst, Belgium
Private Practice of Dr. Guido Mehuys
🇧🇪Tielt, Belgium
Private Practice of Dr. Willy Denier
🇧🇪Genk, Belgium
Private Practice of Dr. Sophie Baeyens
🇧🇪Pulle, Belgium
George Delamare
🇫🇷Blois, France
Centre d'Investigation Clinique
🇫🇷Dommartin les Toul, France
Private Practice of Dr. Jean Boulet-Gercourt
🇫🇷Le Mesnil en vallee, France
Private Practice of Dr. Jacques Samat
🇫🇷Martigues, France
Private Practice of Dr. Josef Junggeburth
🇩🇪Bad Worishofen, Germany
Charite Campus Mitte, Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Klinische Forschung Berlin-Buch GmbH
🇩🇪Berlin, Germany
Private Practice of Dr. Isabelle Schenkenberger
🇩🇪Berlin, Germany
PD Dr. med. Bernhard Winkelmann
🇩🇪Frankfurt, Germany
Private Practice for Internal Medicine & Cardiology
🇩🇪Heidelberg, Germany
Clinical Research Hamburg
🇩🇪Hamburg, Germany
Humayun Mirza, MD, PA
🇺🇸Houston, Texas, United States
Houston Clinical Research Assoc.
🇺🇸Houston, Texas, United States
AppleMed Research, Inc.
🇺🇸Miami, Florida, United States
Aurora Denver Cardiology Associates
🇺🇸Aurora, Colorado, United States
St. Paul Cardiology
🇺🇸St. Paul, Minnesota, United States
Alabama Internal Medicine, PC
🇺🇸Birmingham, Alabama, United States
Greystone Medical Research, LLC
🇺🇸Birmingham, Alabama, United States
Lovelace Scientific Resources, Inc
🇺🇸Phoenix, Arizona, United States
Minneapolis VAMC
🇺🇸Minneapolis, Minnesota, United States
Southwest Heart
🇺🇸Tucson, Arizona, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Central Minnesota Heart Center at St. Cloud Hospital
🇺🇸St. Cloud, Minnesota, United States
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Lifeline Research Institute
🇺🇸Brooklyn, New York, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Tampa Bay Nephrology Associates, PL
🇺🇸Tampa, Florida, United States
Cardiovascular Center of Sarasota
🇺🇸Sarasota, Florida, United States
Ormond Medical Arts Pharmaceutical Research center
🇺🇸Ormond Beach, Florida, United States
University Medical Associates
🇺🇸Louisville, Kentucky, United States
AMR Research Associates, LLC
🇺🇸Bogart, Georgia, United States
Medical Consultants, PC
🇺🇸Muncie, Indiana, United States
Maine Research Associate
🇺🇸Auburn, Maine, United States
PrimeCare Internal Medicine
🇺🇸Biddeford, Maine, United States
Great Lakes Heart Center of Alpena
🇺🇸Alpena, Michigan, United States
Internal Medicine of Nothern Michigan
🇺🇸Petoskey, Michigan, United States
Dr. Jeffrey Chen
🇺🇸Lafayette, Louisiana, United States
Plaza Medical Group, PC
🇺🇸Oklahoma City, Oklahoma, United States
Metrolina Internal Medicine, PA
🇺🇸Charlotte, North Carolina, United States
Physicians East, PA
🇺🇸Winterville, North Carolina, United States
Castlerock Clinical Research Counsultants, LLC
🇺🇸Tulsa, Oklahoma, United States
Internal Medicine of Greer
🇺🇸Greer, South Carolina, United States
Hospital Italiano Regional del Sur
🇦🇷Bahia Blanca, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
Galenos Research
🇺🇸Dallas, Texas, United States
Salim Gopalani, MD, PA
🇺🇸Houston, Texas, United States
Innovative Research of West Florida
🇺🇸Hurst, Texas, United States
Kamlesh N. Dave Cardiology
🇺🇸Hopewell, Virginia, United States
Royal Brisbane & Women's Hospital
🇦🇺Herston, Australia
MD Investigaciones
🇦🇷Ciudad de Buenos Aires, Argentina
Instituto de Cardiologia de Corrientes
🇦🇷Corrientes, Argentina
Framingham Centro Medico
🇦🇷La Plata, Argentina
Hospital General de Agudos "Dr. Abel Zubizarreta"
🇦🇷Buenos Aires, Argentina
Policlinica Bancaria "9 de Julio"
🇦🇷Buenos Aires, Argentina
Diabaid (Instituto de Asistencia Integral en Diabetes)
🇦🇷Ciudad de Buenos Aires, Argentina
Instituto de Investigaciones Clinicas
🇦🇷Rosario, Argentina
U.Z. Brussel
🇧🇪Brussel, Belgium
Private Practice of Dr. Geert Hollanders
🇧🇪De Pinte, Belgium
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Royal Perth Hospital
🇦🇺Perth, Australia
Alfred Hospital
🇦🇺Melbourne, Australia
Hospital Universitario Pedro Ernesto
🇧🇷Rio de Janeiro, Brazil
Private Practice of Dr. Brune Charrier
🇫🇷La Jubaudiere, France
Private Practice of Dr. Thierry Schaupp
🇫🇷Vihiers, France
Region Sjaelland, Storstrommens Sygenhus, Naestved
🇩🇰Naestved, Denmark
Private Practice of dr. Marty Jacques
🇫🇷Murs-Erigne, France
Private Practice of Dr. Alain Boye
🇫🇷Nantes, France
Private Practice of Dr. Francois Volny
🇫🇷Nantes, France
Greenlane Clinical Centre
🇳🇿Greenlane, New Zealand
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Private Practice of Dr. Tobias Marsen
🇩🇪Koeln, Germany
IFG-Institut fur Gesundheitsforderung GmbH
🇩🇪Ruedersdorf, Germany
Dr. Med. Susanne Mindt-Prufert
🇩🇪Hamburg, Germany
Centre for Clinical Research and Effective Practice (CCRep)
🇳🇿Auckland, New Zealand
Cardiology Clinical Trial Unit
🇳🇿Hamilton, New Zealand
Tauranga Hospital
🇳🇿Tauranga, New Zealand
Blackstone Cardiology Associates
🇺🇸Pawtucket, Rhode Island, United States
Consultants in Cardiovascular Med (CIS)
🇺🇸Melrose Park, Illinois, United States
Methodist Medical Center-Heart, Lung & Vascular Institute
🇺🇸Peoria, Illinois, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
The Heart Center, PC
🇺🇸Huntsville, Alabama, United States
Mulberry Medical Associates, PC
🇺🇸Montgomery, Alabama, United States
Cardiovascular Consultants, Ltd.
🇺🇸Glendale, Arizona, United States
Arizona Center for Clinical Research
🇺🇸Glendale, Arizona, United States
Arkansas Primary Care Clinic, PA
🇺🇸Little Rock, Arkansas, United States
Medical Investigations Inc.
🇺🇸Little Rock, Arkansas, United States
HealthFirst Physician of AR, PA dba Convenient Care Clinic
🇺🇸Hot Springs, Arkansas, United States
Highgrove Medical Center
🇺🇸Bakersfield, California, United States
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Pacific Heart Institute
🇺🇸Santa Monica, California, United States
Rancho Cucamonga Clinical Trials
🇺🇸Rancho Cucamonga, California, United States
Maxine Hamilton, MD, PA
🇺🇸Ft. Lauderdale, Florida, United States
Doctors Medical Center of Walton County
🇺🇸Defuniak Springs, Florida, United States
St. John's Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Private Practice of Dr. Bridget Bellingar
🇺🇸Largo, Florida, United States
A+ Research Inc.
🇺🇸Miami, Florida, United States
Northwest Florida Heart Group, PA - Research Dept
🇺🇸Pensacola, Florida, United States
Illinois Heart & Lunch Research
🇺🇸Normal, Illinois, United States
North Shore Cardiologist
🇺🇸Bannockburn, Illinois, United States
Heart Care Center of Charlotte
🇺🇸Charlotte, North Carolina, United States
Charleston Cardiology
🇺🇸Charleston, South Carolina, United States
Scenic City Research
🇺🇸Cleveland, Tennessee, United States
Sergio F Rovner, MD
🇺🇸El Paso, Texas, United States
Executive Health and Research Associates
🇺🇸Madison, Wisconsin, United States
Alpha Medical Research, LLC
🇺🇸Madison, Wisconsin, United States
Fundacion Rusculleda
🇦🇷Cordoba, Argentina
Flinders Medical Centre
🇦🇺Bedford Park, Australia
Private Practice of Dr. Herwig Van Aerde
🇧🇪Genk, Belgium
Private Practice of Dr. Luc Capiau
🇧🇪Wetteren, Belgium
Private Practice of Dr. Gildas Ganuchaud
🇫🇷Le Temple-de-Bretagne, France
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Southeast Texas Clinical Research Center
🇺🇸Beaumont, Texas, United States
North Texas Medical Research
🇺🇸Plano, Texas, United States