Clinical trial NCT00353574: DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypertension
Keywords: Resistant Hypertension
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2006-07-18
Enrollment: 282
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in trough sitting systolic and diastolic blood pressure
timeFrame: Baseline to Week 14
Secondary outcomes:
measure: Change in mean 24-hour systolic and diastolic ambulatory blood pressures.
timeFrame: Baseline to Week 14
measure: Percentage of subjects who reach systolic blood pressure goal
timeFrame: Week 14
measure: Change in estimated glomerular filtration rate (eGFR)
timeFrame: Baseline to Week 14
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Comprehensive Heart Failure Center
state: Alabama
city: Tucson
country: United States
facility: Canyon Clinical Research
state: Arizona
city: Inglewood
country: United States
facility: Chrishard Medical Group
state: California
city: Los Angeles
country: United States
facility: VA Medical Center - WLA
state: California
city: Sacramento
country: United States
facility: Sacramento Heart and Vascular
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Denver
country: United States
facility: Complete Renal Care
state: Colorado
city: Bridgeport
country: United States
facility: Connecticut Clinical Research, LLC
state: Connecticut
city: Washington
country: United States
facility: MedStar Diabetes Institute at Washington Hospital Center
state: District of Columbia
city: Fort Walton Beach
country: United States
facility: White-Wilson Medical Center
state: Florida
city: Hialeah
country: United States
facility: A.G.A. Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical
state: Florida
city: Jupiter
country: United States
facility: Ricardo A. Bedoya, Cardiology
state: Florida
city: Miami
country: United States
facility: International Research Association
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center of Sarasota
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Nephrology Associates, PL
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Calhoun
country: United States
facility: Global Research Partners
state: Georgia
city: Honolulu
country: United States
facility: Kula Research
state: Hawaii
city: Elk Grove Village
country: United States
facility: Chicago Heart & Vein Clinic
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Slidell
country: United States
facility: Medical Research Institute
state: Louisiana
city: Auburn
country: United States
facility: Androscoggin Cardiology Associates
state: Maine
city: Auburn
country: United States
facility: Maine Research Associate
state: Maine
city: Scarborough
country: United States
facility: Cardiovascular Consultants of Maine
state: Maine
city: Reisterstown
country: United States
facility: Clinical Associates
state: Maryland
city: Rockville
country: United States
facility: Rockville Internal Medicine Group
state: Maryland
city: Benzonia
country: United States
facility: Professional Clinical Research
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Interlochen
country: United States
facility: Professional Clinical Research
state: Michigan
city: Pahrump
country: United States
facility: Specialty Medical Center
state: Nevada
city: Greenville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Southwest Cardiology Associates
state: Oklahoma
city: Tulsa
country: United States
facility: Castlerock Clinical Research Consultants
state: Oklahoma
city: Hillsboro
country: United States
facility: Hillsboro Cardiology, PC
state: Oregon
city: Allentown
country: United States
facility: Northeast Clinical Research Centers, Inc.
state: Pennsylvania
city: Camp Hill
country: United States
facility: Heritage Cardiology Associates
state: Pennsylvania
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Lansdale
country: United States
facility: Green and Seidner Family Practice Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Providence
country: United States
facility: RI Hospital
state: Rhode Island
city: Columbia
country: United States
facility: Neem Research Group, Inc.
state: South Carolina
city: Desoto
country: United States
facility: Internal Medicine & Industrial Medicine
state: Texas
city: Ft Worth
country: United States
facility: T&R Clinical, P.A.
state: Texas
city: Lewisville
country: United States
facility: Pri-Med Care
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: Burke
country: United States
facility: Burke Internal Medicine, Inc.
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Tacoma
country: United States
facility: Liberty Research Center
state: Washington
city: Buenos Aires
country: Argentina
facility: CIMEL
city: Buenos Aires
country: Argentina
facility: DIM (Clinica Privada)
city: Buenos Aires
country: Argentina
facility: Fundapres
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Jose Maria Ramos Meijia
city: Buenos Aires
country: Argentina
facility: Hospital Municipal Bernardo Houssay
city: Buenos Aires
country: Argentina
facility: Medeos
city: Buenos Aires
country: Argentina
facility: Sanatorio Municipal
city: Sao Paulo
country: Brazil
facility: Centro Integrado Hospital do Rim e Hipertensao
city: Sao Paulo
country: Brazil
facility: Centro Integrado Hospital
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Center
state: Ontario
city: Kitchener
country: Canada
facility: Clinical Research Solutions
state: Ontario
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: København
country: Denmark
facility: Bispebjerg Hospital
city: Dommartin les Toul
country: France
facility: CIC Hopital Jeanne D'Arc
city: Grenoble Cedex
country: France
facility: CHU de Grenoble
city: Strasbourg Cedex
country: France
facility: Hôpital Civil, Service HTA maladies vasculaires
city: Stockholm
country: Sweden
facility: Cardiovascular Research, Karolinska Institue
city: Umea
country: Sweden
facility: University Hospital Umea
city: Scotland
country: United Kingdom
facility: Townhead Surgery
city: Wiltshire
country: United Kingdom
facility: Avenue Surgery
city: Wiltshire
country: United Kingdom
facility: Hathaway Medical Centre
Study officials:
References: