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

NCT00353574 | Terminated Phase 3 DMC

• 1 other identifier: DAR-311-E
• Study Type: interventional
• Target: 282
• Locations: 8 countries
• Sites: 75

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.

Conditions

Hypertension

Keywords

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in trough sitting systolic and diastolic blood pressure

  Baseline to Week 14

Secondary Outcomes (3)

• Change in mean 24-hour systolic and diastolic ambulatory blood pressures.

  Baseline to Week 14

• Percentage of subjects who reach systolic blood pressure goal

  Week 14

• Change in estimated glomerular filtration rate (eGFR)

  Baseline to Week 14

Study Arms (3)

Darusentan 50 mg

EXPERIMENTAL

Darusentan 50 mg administered orally once daily

Drug: Darusentan

Darusentan 100 mg

EXPERIMENTAL

Darusentan 100 mg administered orally once daily

Drug: Darusentan

Darusentan 300 mg

EXPERIMENTAL

Darusentan 300 mg administered orally once daily

Drug: Darusentan

Interventions

Darusentan DRUG

Darusentan capsules administered orally once daily

Darusentan 100 mg; Darusentan 300 mg; Darusentan 50 mg

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (75)

Comprehensive Heart Failure Center

Mobile, Alabama, 36608, United States

Location

Canyon Clinical Research

Tucson, Arizona, 85712, United States

Location

Chrishard Medical Group

Inglewood, California, 90301, United States

Location

VA Medical Center - WLA

Los Angeles, California, 90073, United States

Location

Sacramento Heart and Vascular

Sacramento, California, 95825, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Complete Renal Care

Denver, Colorado, 80220, United States

Location

Connecticut Clinical Research, LLC

Bridgeport, Connecticut, 06606, United States

Location

MedStar Diabetes Institute at Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

White-Wilson Medical Center

Fort Walton Beach, Florida, 32569, United States

Location

A.G.A. Clinical Trials

Hialeah, Florida, 33012, United States

Location

Jacksonville Center for Clinical

Jacksonville, Florida, 32216, United States

Location

Ricardo A. Bedoya, Cardiology

Jupiter, Florida, 33458, United States

Location

International Research Association

Miami, Florida, 33156, United States

Location

Cardiovascular Center of Sarasota

Sarasota, Florida, 34231, United States

Location

Tampa Bay Nephrology Associates, PL

Tampa, Florida, 33603, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

Global Research Partners

Calhoun, Georgia, 30701, United States

Location

Kula Research

Honolulu, Hawaii, 96816, United States

Location

Chicago Heart & Vein Clinic

Elk Grove Village, Illinois, 60007, United States

Location

Evanston Northwestern Healthcare

Evanston, Illinois, 60201, United States

Location

Clinical Investigation Specialists, Inc.

Gurnee, Illinois, 60031, United States

Location

Midwest Heart Foundation

Lombard, Illinois, 60148, United States

Location

Medical Research Institute

Slidell, Louisiana, 70458, United States

Location

Androscoggin Cardiology Associates

Auburn, Maine, 04210, United States

Location

Maine Research Associate

Auburn, Maine, 04210, United States

Location

Cardiovascular Consultants of Maine

Scarborough, Maine, 04074, United States

Location

Clinical Associates

Reisterstown, Maryland, 21136, United States

Location

Rockville Internal Medicine Group

Rockville, Maryland, 20854, United States

Location

Professional Clinical Research

Benzonia, Michigan, 49616, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Professional Clinical Research

Interlochen, Michigan, 49643, United States

Location

Specialty Medical Center

Pahrump, Nevada, 89048, United States

Location

Physicians East, PA

Greenville, North Carolina, 27834, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

COR Clinical Research

Oklahoma City, Oklahoma, 73003, United States

Location

Southwest Cardiology Associates

Oklahoma City, Oklahoma, 73109, United States

Location

Castlerock Clinical Research Consultants

Tulsa, Oklahoma, 74136, United States

Location

Hillsboro Cardiology, PC

Hillsboro, Oregon, 97123, United States

Location

Northeast Clinical Research Centers, Inc.

Allentown, Pennsylvania, 18103, United States

Location

Heritage Cardiology Associates

Camp Hill, Pennsylvania, 17011, United States

Location

Brandywine Clinical Research

Downingtown, Pennsylvania, 19335, United States

Location

Green and Seidner Family Practice Associates

Lansdale, Pennsylvania, 19446, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

RI Hospital

Providence, Rhode Island, 02903, United States

Location

Neem Research Group, Inc.

Columbia, South Carolina, 29201, United States

Location

Internal Medicine & Industrial Medicine

DeSoto, Texas, 75115, United States

Location

T&R Clinical, P.A.

Fort Worth, Texas, 76117, United States

Location

Pri-Med Care

Lewisville, Texas, 75067, United States

Location

Innovative Clinical Trials

San Antonio, Texas, 78229, United States

Location

Burke Internal Medicine, Inc.

Burke, Virginia, 22015, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Liberty Research Center

Tacoma, Washington, 98405, United States

Location

CIMEL

Buenos Aires, Argentina

Location

DIM (Clinica Privada)

Buenos Aires, Argentina

Location

Fundapres

Buenos Aires, Argentina

Location

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

Location

Hospital Jose Maria Ramos Meijia

Buenos Aires, Argentina

Location

Hospital Municipal Bernardo Houssay

Buenos Aires, Argentina

Location

Medeos

Buenos Aires, Argentina

Location

Sanatorio Municipal

Buenos Aires, Argentina

Location

Centro Integrado Hospital do Rim e Hipertensao

São Paulo, Brazil

Location

Centro Integrado Hospital

São Paulo, Brazil

Location

Cambridge Cardiac Care Center

Cambridge, Ontario, N3H 3R8, Canada

Location

Clinical Research Solutions

Kitchener, Ontario, N2G 1G5, Canada

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Hvidovre Hospital

Hvidovre, Denmark

Location

CIC Hopital Jeanne D'Arc

Dommartin-lès-Toul, France

Location

CHU de Grenoble

Grenoble, France

Location

Hôpital Civil, Service HTA maladies vasculaires

Strasbourg, France

Location

Cardiovascular Research, Karolinska Institue

Stockholm, Sweden

Location

University Hospital Umea

Umeå, Sweden

Location

Townhead Surgery

Scotland, United Kingdom

Location

Avenue Surgery

Wiltshire, United Kingdom

Location

Hathaway Medical Centre

Wiltshire, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension

Interventions

darusentan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2006
• First Posted: July 18, 2006
• Study Start: September 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 18, 2014

Record last verified: 2014-02

Locations

CA (2); FR (3); BR (2); US (53); AR (8); DK (2); SE (2); GB (3)