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

NCT ID: NCT00353574

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Darusentan 50 mg

Darusentan 50 mg administered orally once daily

Group Type EXPERIMENTAL

Darusentan

Intervention Type DRUG

Darusentan capsules administered orally once daily

Darusentan 100 mg

Darusentan 100 mg administered orally once daily

Group Type EXPERIMENTAL

Darusentan

Intervention Type DRUG

Darusentan capsules administered orally once daily

Darusentan 300 mg

Darusentan 300 mg administered orally once daily

Group Type EXPERIMENTAL

Darusentan

Intervention Type DRUG

Darusentan capsules administered orally once daily

Interventions

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Darusentan

Darusentan capsules administered orally once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Comprehensive Heart Failure Center

Mobile, Alabama, United States

Site Status

Canyon Clinical Research

Tucson, Arizona, United States

Site Status

Chrishard Medical Group

Inglewood, California, United States

Site Status

VA Medical Center - WLA

Los Angeles, California, United States

Site Status

Sacramento Heart and Vascular

Sacramento, California, United States

Site Status

Apex Research Institute

Santa Ana, California, United States

Site Status

Complete Renal Care

Denver, Colorado, United States

Site Status

Connecticut Clinical Research, LLC

Bridgeport, Connecticut, United States

Site Status

MedStar Diabetes Institute at Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

White-Wilson Medical Center

Fort Walton Beach, Florida, United States

Site Status

A.G.A. Clinical Trials

Hialeah, Florida, United States

Site Status

Jacksonville Center for Clinical

Jacksonville, Florida, United States

Site Status

Ricardo A. Bedoya, Cardiology

Jupiter, Florida, United States

Site Status

International Research Association

Miami, Florida, United States

Site Status

Cardiovascular Center of Sarasota

Sarasota, Florida, United States

Site Status

Tampa Bay Nephrology Associates, PL

Tampa, Florida, United States

Site Status

Metabolic Research Institute, Inc.

West Palm Beach, Florida, United States

Site Status

Global Research Partners

Calhoun, Georgia, United States

Site Status

Kula Research

Honolulu, Hawaii, United States

Site Status

Chicago Heart & Vein Clinic

Elk Grove Village, Illinois, United States

Site Status

Evanston Northwestern Healthcare

Evanston, Illinois, United States

Site Status

Clinical Investigation Specialists, Inc.

Gurnee, Illinois, United States

Site Status

Midwest Heart Foundation

Lombard, Illinois, United States

Site Status

Medical Research Institute

Slidell, Louisiana, United States

Site Status

Androscoggin Cardiology Associates

Auburn, Maine, United States

Site Status

Maine Research Associate

Auburn, Maine, United States

Site Status

Cardiovascular Consultants of Maine

Scarborough, Maine, United States

Site Status

Clinical Associates

Reisterstown, Maryland, United States

Site Status

Rockville Internal Medicine Group

Rockville, Maryland, United States

Site Status

Professional Clinical Research

Benzonia, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Professional Clinical Research

Interlochen, Michigan, United States

Site Status

Specialty Medical Center

Pahrump, Nevada, United States

Site Status

Physicians East, PA

Greenville, North Carolina, United States

Site Status

The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

Site Status

COR Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Southwest Cardiology Associates

Oklahoma City, Oklahoma, United States

Site Status

Castlerock Clinical Research Consultants

Tulsa, Oklahoma, United States

Site Status

Hillsboro Cardiology, PC

Hillsboro, Oregon, United States

Site Status

Northeast Clinical Research Centers, Inc.

Allentown, Pennsylvania, United States

Site Status

Heritage Cardiology Associates

Camp Hill, Pennsylvania, United States

Site Status

Brandywine Clinical Research

Downingtown, Pennsylvania, United States

Site Status

Green and Seidner Family Practice Associates

Lansdale, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

RI Hospital

Providence, Rhode Island, United States

Site Status

Neem Research Group, Inc.

Columbia, South Carolina, United States

Site Status

Internal Medicine & Industrial Medicine

DeSoto, Texas, United States

Site Status

T&R Clinical, P.A.

Fort Worth, Texas, United States

Site Status

Pri-Med Care

Lewisville, Texas, United States

Site Status

Innovative Clinical Trials

San Antonio, Texas, United States

Site Status

Burke Internal Medicine, Inc.

Burke, Virginia, United States

Site Status

Manassas Clinical Research Center

Manassas, Virginia, United States

Site Status

Liberty Research Center

Tacoma, Washington, United States

Site Status

CIMEL

Buenos Aires, , Argentina

Site Status

DIM (Clinica Privada)

Buenos Aires, , Argentina

Site Status

Fundapres

Buenos Aires, , Argentina

Site Status

Hospital Britanico de Buenos Aires

Buenos Aires, , Argentina

Site Status

Hospital Jose Maria Ramos Meijia

Buenos Aires, , Argentina

Site Status

Hospital Municipal Bernardo Houssay

Buenos Aires, , Argentina

Site Status

Medeos

Buenos Aires, , Argentina

Site Status

Sanatorio Municipal

Buenos Aires, , Argentina

Site Status

Centro Integrado Hospital do Rim e Hipertensao

São Paulo, , Brazil

Site Status

Centro Integrado Hospital

São Paulo, , Brazil

Site Status

Cambridge Cardiac Care Center

Cambridge, Ontario, Canada

Site Status

Clinical Research Solutions

Kitchener, Ontario, Canada

Site Status

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Hvidovre Hospital

Hvidovre, , Denmark

Site Status

CIC Hopital Jeanne D'Arc

Dommartin-lès-Toul, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

Hôpital Civil, Service HTA maladies vasculaires

Strasbourg, , France

Site Status

Cardiovascular Research, Karolinska Institue

Stockholm, , Sweden

Site Status

University Hospital Umea

Umeå, , Sweden

Site Status

Townhead Surgery

Scotland, , United Kingdom

Site Status

Avenue Surgery

Wiltshire, , United Kingdom

Site Status

Hathaway Medical Centre

Wiltshire, , United Kingdom

Site Status

Countries

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United States Argentina Brazil Canada Denmark France Sweden United Kingdom

Related Links

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Other Identifiers

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DAR-311-E

Identifier Type: -

Identifier Source: org_study_id

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