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

Last updated: February 19, 2014
Sponsor: Gilead Sciences
Overall Status: Terminated

Phase

3

Condition

Vascular Diseases

Williams Syndrome

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT00353574
DAR-311-E
  • Ages 35-80
  • All Genders

Study 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

Inclusion Criteria:

  • Subjects who have completed the Treatment Period of clinical trial DAR-311

  • Receiving and adhering to full doses of appropriate guideline-recommendedantihypertensive drugs from three different classes of antihypertensive agents,including a diuretic

Exclusion

Exclusion Criteria:

  • Subjects who discontinued treatment with study drug prior to the end of the TreatmentPeriod 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

Total Participants: 282
Study Start date:
September 01, 2006
Estimated Completion Date:
April 30, 2010

Connect with a study center

  • CIMEL

    Buenos Aires,
    Argentina

    Site Not Available

  • DIM (Clinica Privada)

    Buenos Aires,
    Argentina

    Site Not Available

  • Fundapres

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Britanico de Buenos Aires

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Jose Maria Ramos Meijia

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Municipal Bernardo Houssay

    Buenos Aires,
    Argentina

    Site Not Available

  • Medeos

    Buenos Aires,
    Argentina

    Site Not Available

  • Sanatorio Municipal

    Buenos Aires,
    Argentina

    Site Not Available

  • Centro Integrado Hospital

    Sao Paulo,
    Brazil

    Site Not Available

  • Centro Integrado Hospital do Rim e Hipertensao

    Sao Paulo,
    Brazil

    Site Not Available

  • Cambridge Cardiac Care Center

    Cambridge, Ontario N3H 3R8
    Canada

    Site Not Available

  • Clinical Research Solutions

    Kitchener, Ontario N2G 1G5
    Canada

    Site Not Available

  • Hvidovre Hospital

    Hvidovre,
    Denmark

    Site Not Available

  • Bispebjerg Hospital

    København,
    Denmark

    Site Not Available

  • Bispebjerg Hospital

    København,
    Denmark

    Site Not Available

  • CIC Hopital Jeanne D'Arc

    Dommartin les Toul,
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble Cedex,
    France

    Site Not Available

  • Hôpital Civil, Service HTA maladies vasculaires

    Strasbourg Cedex,
    France

    Site Not Available

  • Cardiovascular Research, Karolinska Institue

    Stockholm,
    Sweden

    Site Not Available

  • University Hospital Umea

    Umea,
    Sweden

    Site Not Available

  • Townhead Surgery

    Scotland,
    United Kingdom

    Site Not Available

  • Avenue Surgery

    Wiltshire,
    United Kingdom

    Site Not Available

  • Hathaway Medical Centre

    Wiltshire,
    United Kingdom

    Site Not Available

  • Comprehensive Heart Failure Center

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Canyon Clinical Research

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Chrishard Medical Group

    Inglewood, California 90301
    United States

    Site Not Available

  • VA Medical Center - WLA

    Los Angeles, California 90073
    United States

    Site Not Available

  • Sacramento Heart and Vascular

    Sacramento, California 95825
    United States

    Site Not Available

  • Apex Research Institute

    Santa Ana, California 92705
    United States

    Site Not Available

  • Complete Renal Care

    Denver, Colorado 80220
    United States

    Site Not Available

  • Connecticut Clinical Research, LLC

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • MedStar Diabetes Institute at Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • White-Wilson Medical Center

    Fort Walton Beach, Florida 32569
    United States

    Site Not Available

  • A.G.A. Clinical Trials

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Jacksonville Center for Clinical

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Ricardo A. Bedoya, Cardiology

    Jupiter, Florida 33458
    United States

    Site Not Available

  • International Research Association

    Miami, Florida 33156
    United States

    Site Not Available

  • Cardiovascular Center of Sarasota

    Sarasota, Florida 34231
    United States

    Site Not Available

  • Tampa Bay Nephrology Associates, PL

    Tampa, Florida 33603
    United States

    Site Not Available

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Global Research Partners

    Calhoun, Georgia 30701
    United States

    Site Not Available

  • Kula Research

    Honolulu, Hawaii 96816
    United States

    Site Not Available

  • Chicago Heart & Vein Clinic

    Elk Grove Village, Illinois 60007
    United States

    Site Not Available

  • Evanston Northwestern Healthcare

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Clinical Investigation Specialists, Inc.

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Midwest Heart Foundation

    Lombard, Illinois 60148
    United States

    Site Not Available

  • Medical Research Institute

    Slidell, Louisiana 70458
    United States

    Site Not Available

  • Androscoggin Cardiology Associates

    Auburn, Maine 04210
    United States

    Site Not Available

  • Maine Research Associate

    Auburn, Maine 04210
    United States

    Site Not Available

  • Cardiovascular Consultants of Maine

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Clinical Associates

    Reisterstown, Maryland 21136
    United States

    Site Not Available

  • Rockville Internal Medicine Group

    Rockville, Maryland 20854
    United States

    Site Not Available

  • Professional Clinical Research

    Benzonia, Michigan 49616
    United States

    Site Not Available

  • Hurley Medical Center

    Flint, Michigan 48503
    United States

    Site Not Available

  • Professional Clinical Research

    Interlochen, Michigan 49643
    United States

    Site Not Available

  • Specialty Medical Center

    Pahrump, Nevada 89048
    United States

    Site Not Available

  • Physicians East, PA

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • COR Clinical Research

    Oklahoma City, Oklahoma 73003
    United States

    Site Not Available

  • Southwest Cardiology Associates

    Oklahoma City, Oklahoma 73109
    United States

    Site Not Available

  • Castlerock Clinical Research Consultants

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Hillsboro Cardiology, PC

    Hillsboro, Oregon 97123
    United States

    Site Not Available

  • Northeast Clinical Research Centers, Inc.

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Heritage Cardiology Associates

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • Brandywine Clinical Research

    Downingtown, Pennsylvania 19335
    United States

    Site Not Available

  • Green and Seidner Family Practice Associates

    Lansdale, Pennsylvania 19446
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • RI Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Neem Research Group, Inc.

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Internal Medicine & Industrial Medicine

    Desoto, Texas 75115
    United States

    Site Not Available

  • T&R Clinical, P.A.

    Ft Worth, Texas 76117
    United States

    Site Not Available

  • Pri-Med Care

    Lewisville, Texas 75067
    United States

    Site Not Available

  • Innovative Clinical Trials

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Burke Internal Medicine, Inc.

    Burke, Virginia 22015
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Liberty Research Center

    Tacoma, Washington 98405
    United States

    Site Not Available

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