Clinical trial NCT00389675: DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
Official title: A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects With Resistant Hypertension Despite Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2006-10-19
Enrollment: 661
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: SELECTED INCLUSION CRITERIA:

1. Subjects must be competent to provide written informed consent;
2. Subjects must have completed the Maintenance Period of the DAR-312 study.

SELECTED EXCLUSION CRITERIA:

1. Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 due to a study drug-related AE;
2. Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.

Primary outcomes:
measure: Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
timeFrame: Baseline to Week 14
measure: Percentage of subjects who reach systolic blood pressure goal
timeFrame: Week 14
measure: Change from baseline in estimated glomerular filtration rate (eGFR)
timeFrame: Baseline to Week 14
Secondary outcomes:
measure: Change from baseline in trough sitting systolic and diastolic blood pressures
timeFrame: Baseline to Week 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Internal Medicine, PC
state: Alabama
city: Birmingham
country: United States
facility: Greystone Medical Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: The Heart Center, PC
state: Alabama
city: Montgomery
country: United States
facility: Mulberry Medical Associates, PC
state: Alabama
city: Glendale
country: United States
facility: Arizona Center for Clinical Research
state: Arizona
city: Glendale
country: United States
facility: Cardiovascular Consultants, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Lovelace Scientific Resource, Inc.
state: Arizona
city: Sierra Vista
country: United States
facility: Cochise Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Southwest Heart
state: Arizona
city: Hot Springs
country: United States
facility: HealthFirst Physicians of AR, PA dba Convenient Care Clinic
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Clinical
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic, PA
state: Arkansas
city: Little Rock
country: United States
facility: Medical Investigators, Inc.
state: Arkansas
city: Bakersfield
country: United States
facility: Highgrove Medical Center
state: California
city: Bakersfield
country: United States
facility: Central Cardiology Medical Clinic
state: California
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Trials
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Torrance
country: United States
facility: Los angeles biomedical research Institute at Harbor-UCLA Medical Center
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Denver
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Defuniak Springs
country: United States
facility: Doctors Medical center of Walton County
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Ft Lauderdale
country: United States
facility: Maxine Hamilton, MD, PA
state: Florida
city: Jacksonville
country: United States
facility: St John's Center for Clinical Research
state: Florida
city: Largo
country: United States
facility: Private Practice of Dr. Bridget Bellingar
state: Florida
city: Miami
country: United States
facility: A + Research Inc.
state: Florida
city: Miami
country: United States
facility: AppleMed Research, Inc.
state: Florida
city: N. Miami Beach
country: United States
facility: Internal Medicine Associates of South Florida
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Pensacola
country: United States
facility: Nothwest Florida Heart Group, PA-Research Dept
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center of Sarasota
state: Florida
city: St Petersburg
country: United States
facility: Suncoast Cardiovascular Research, Inc
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Nephrology Associates, PL
state: Florida
city: Tampa
country: United States
facility: Orlando Rangel, MD, PA
state: Florida
city: Bogart
country: United States
facility: AMR Research Associates, LLC
state: Georgia
city: Tucker
country: United States
facility: Atlanta Vascular Research Foundation
state: Georgia
city: Melrose Park
country: United States
facility: Consultants in Cardiovascular Med (CIS)
state: Illinois
city: Normal
country: United States
facility: Illinois Heart & Lunch Research Center
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center-Heart, Lung & Vascular Institute
state: Illinois
city: Muncie
country: United States
facility: Medical consultants, PC
state: Indiana
city: Louisville
country: United States
facility: University Medical Associates
state: Kentucky
city: Lafayette
country: United States
facility: Dr. Jeffrey Chen
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc.
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Biddeford
country: United States
facility: PrimeCare Internal Medicine
state: Maine
city: Alpena
country: United States
facility: Great Lakes Heart Center of Alpena
state: Michigan
city: Petoskey
country: United States
facility: Internal Medicine of Northern Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VAMC
state: Minnesota
city: St. Cloud
country: United States
facility: Central Minnesota Heart Center at St. Cloud Hospital
state: Minnesota
city: St. Paul
country: United States
facility: St. Paul Cardiology
state: Minnesota
city: Kalispell
country: United States
facility: Glacier View Cardiology, PC
state: Montana
city: Las Vegas
country: United States
facility: Impact Clinical Trials
state: Nevada
city: Linden
country: United States
facility: NJ Heart
state: New Jersey
city: Passaic
country: United States
facility: New Jersey Physicians
state: New Jersey
city: Brooklyn
country: United States
facility: Lifeline Research Institute
state: New York
city: Charlotte
country: United States
facility: Metrolina Internal Medicine, PA
state: North Carolina
city: Charlotte
country: United States
facility: Heart Care Center of Charlotte
state: North Carolina
city: Winterville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Oklahoma City
country: United States
facility: Plaza Medical Group, PC
state: Oklahoma
city: Tulsa
country: United States
facility: Castlerock Clinical Research Consultants, LLC
state: Oklahoma
city: Ashland
country: United States
facility: Integrated Medical Research PC
state: Oregon
city: Pawtucket
country: United States
facility: Blackstone Cardiology Associates
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Cardiology
state: South Carolina
city: Greenville
country: United States
facility: Paris View Family Practice
state: South Carolina
city: Greer
country: United States
facility: Internal Medicine of Greer
state: South Carolina
city: Cleveland
country: United States
facility: Scenic City Research
state: Tennessee
city: Beaumont
country: United States
facility: Southeast Texas Clinical Research Center
state: Texas
city: Dallas
country: United States
facility: Cardiovascular Research Inst. of Dallas
state: Texas
city: Dallas
country: United States
facility: Galenos Research
state: Texas
city: El Paso
country: United States
facility: Sergio F Rovner, MD
state: Texas
city: Houston
country: United States
facility: Salim Gopalani, MD, PA
state: Texas
city: Houston
country: United States
facility: Humayum Mirza, MD, PA
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Assoc.
state: Texas
city: Hurst
country: United States
facility: Innovative Research of West Florida
state: Texas
city: Plano
country: United States
facility: North Texas Medical Research
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care/University of Vermont
state: Vermont
city: Hopewell
country: United States
facility: Kamlesh N Dave Cardiology
state: Virginia
city: Charleston
country: United States
facility: WVU Physicicans of Charleston
state: West Virginia
city: Madison
country: United States
facility: Alpha Medical Research, LLC
state: Wisconsin
city: Madison
country: United States
facility: Executive Health and Research Associates
state: Wisconsin
city: Bahia Blanca
country: Argentina
facility: Instituto de Investigaciones Clinicas Bahia Blanca
city: Buenos Aires
country: Argentina
facility: Consultorios Medicos Privados S.A.
city: Buenos Aires
country: Argentina
facility: Policlinica Bancaria "9 de Julio"
city: Ciudad de Buenos Aires
country: Argentina
facility: Diabaid (Instituto de Asistencia Integral en Diabetes)
city: Ciudad de Buenos Aires
country: Argentina
facility: MD Investigaciones
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia de Corrientes
city: La Plata
country: Argentina
facility: Framingham Centro Medico
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas de Quilmes
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas
city: Santa Fe
country: Argentina
facility: Centro de Investigaciones clincas de Litoral
city: Bedford
country: Australia
facility: Flinders Medical Centre
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Rio de Janeiro
country: Brazil
facility: Private Practice of Dr. Herwig Van Aerde
Study officials:
References: