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NCT00353574 Clinical Trial

DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension

Hypertension Clinical Trial

— Darusentan  

Official title:
DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311-E)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00353574
Other study ID # DAR-311-E
Secondary ID
Status Terminated
Phase Phase 3
First received July 17, 2006
Last updated February 19, 2014
Start date September 2006
Est. completion date April 2010

Study information
Verified date February 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 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.

Recruitment information / eligibility
Status Terminated
Enrollment 282
Est. completion date April 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

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 administered orally once daily

Locations
Country Name City State
Argentina CIMEL Buenos Aires
Argentina DIM (Clinica Privada) Buenos Aires
Argentina Fundapres Buenos Aires
Argentina Hospital Britanico de Buenos Aires Buenos Aires
Argentina Hospital Jose Maria Ramos Meijia Buenos Aires
Argentina Hospital Municipal Bernardo Houssay Buenos Aires
Argentina Medeos Buenos Aires
Argentina Sanatorio Municipal Buenos Aires
Brazil Centro Integrado Hospital Sao Paulo
Brazil Centro Integrado Hospital do Rim e Hipertensao Sao Paulo
Canada Cambridge Cardiac Care Center Cambridge Ontario
Canada Clinical Research Solutions Kitchener Ontario
Denmark Hvidovre Hospital Hvidovre
Denmark Bispebjerg Hospital København
France CIC Hopital Jeanne D'Arc Dommartin les Toul
France CHU de Grenoble Grenoble Cedex
France Hôpital Civil, Service HTA maladies vasculaires Strasbourg Cedex
Sweden Cardiovascular Research, Karolinska Institue Stockholm
Sweden University Hospital Umea Umea
United Kingdom Townhead Surgery Scotland
United Kingdom Avenue Surgery Wiltshire
United Kingdom Hathaway Medical Centre Wiltshire
United States Northeast Clinical Research Centers, Inc. Allentown Pennsylvania
United States Androscoggin Cardiology Associates Auburn Maine
United States Maine Research Associate Auburn Maine
United States Professional Clinical Research Benzonia Michigan
United States Connecticut Clinical Research, LLC Bridgeport Connecticut
United States Burke Internal Medicine, Inc. Burke Virginia
United States Global Research Partners Calhoun Georgia
United States Heritage Cardiology Associates Camp Hill Pennsylvania
United States The Lindner Clinical Trial Center Cincinnati Ohio
United States Neem Research Group, Inc. Columbia South Carolina
United States Complete Renal Care Denver Colorado
United States Internal Medicine & Industrial Medicine Desoto Texas
United States Brandywine Clinical Research Downingtown Pennsylvania
United States Chicago Heart & Vein Clinic Elk Grove Village Illinois
United States Evanston Northwestern Healthcare Evanston Illinois
United States Hurley Medical Center Flint Michigan
United States White-Wilson Medical Center Fort Walton Beach Florida
United States T&R Clinical, P.A. Ft Worth Texas
United States Physicians East, PA Greenville North Carolina
United States Clinical Investigation Specialists, Inc. Gurnee Illinois
United States A.G.A. Clinical Trials Hialeah Florida
United States Hillsboro Cardiology, PC Hillsboro Oregon
United States Kula Research Honolulu Hawaii
United States Chrishard Medical Group Inglewood California
United States Professional Clinical Research Interlochen Michigan
United States Jacksonville Center for Clinical Jacksonville Florida
United States Ricardo A. Bedoya, Cardiology Jupiter Florida
United States Green and Seidner Family Practice Associates Lansdale Pennsylvania
United States Pri-Med Care Lewisville Texas
United States Midwest Heart Foundation Lombard Illinois
United States VA Medical Center - WLA Los Angeles California
United States Manassas Clinical Research Center Manassas Virginia
United States International Research Association Miami Florida
United States Comprehensive Heart Failure Center Mobile Alabama
United States COR Clinical Research Oklahoma City Oklahoma
United States Southwest Cardiology Associates Oklahoma City Oklahoma
United States Specialty Medical Center Pahrump Nevada
United States Temple University Hospital Philadelphia Pennsylvania
United States RI Hospital Providence Rhode Island
United States Clinical Associates Reisterstown Maryland
United States Rockville Internal Medicine Group Rockville Maryland
United States Sacramento Heart and Vascular Sacramento California
United States Innovative Clinical Trials San Antonio Texas
United States Apex Research Institute Santa Ana California
United States Cardiovascular Center of Sarasota Sarasota Florida
United States Cardiovascular Consultants of Maine Scarborough Maine
United States Medical Research Institute Slidell Louisiana
United States Liberty Research Center Tacoma Washington
United States Tampa Bay Nephrology Associates, PL Tampa Florida
United States Canyon Clinical Research Tucson Arizona
United States Castlerock Clinical Research Consultants Tulsa Oklahoma
United States MedStar Diabetes Institute at Washington Hospital Center Washington District of Columbia
United States Metabolic Research Institute, Inc. West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Denmark,  France,  Sweden,  United Kingdom, 

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