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NCT00389675 Clinical Trial

DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension

Hypertension Clinical Trial

— Darusentan  

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00389675
Other study ID # Protocol DAR-312-E
Secondary ID
Status Terminated
Phase Phase 3
First received October 17, 2006
Last updated January 3, 2014
Start date May 2007
Est. completion date May 2010

Study information
Verified date January 2014
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 661
Est. completion date May 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Darusentan
Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
• Guanfacine
Guanfacine 1 mg capsules administered orally once daily

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

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure Baseline to Week 14 No
Primary Percentage of subjects who reach systolic blood pressure goal Week 14 No
Primary Change from baseline in estimated glomerular filtration rate (eGFR) Baseline to Week 14 No
Secondary Change from baseline in trough sitting systolic and diastolic blood pressures Baseline to Week 14 No
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