DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension

NCT ID: NCT00389675

Last Updated: 2014-01-06

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

661 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-05-31

Brief Summary

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This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.

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

Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily

Group Type EXPERIMENTAL

Darusentan

Intervention Type DRUG

Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily

Guanfacine

Guanfacine 1 mg capsules administered orally once daily

Group Type ACTIVE_COMPARATOR

Guanfacine

Intervention Type DRUG

Guanfacine 1 mg capsules administered orally once daily

Interventions

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Darusentan

Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily

Intervention Type DRUG

Guanfacine

Guanfacine 1 mg capsules administered orally once daily

Intervention Type DRUG

Other Intervention Names

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LU 135252

Eligibility Criteria

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Inclusion Criteria

1. Subjects must be competent to provide written informed consent;
2. Subjects must have completed the Maintenance Period of the DAR-312 study.

Exclusion Criteria

1. Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 due to a study drug-related AE;
2. Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.
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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Alabama Internal Medicine, PC

Birmingham, Alabama, United States

Site Status

Greystone Medical Research, LLC

Birmingham, Alabama, United States

Site Status

The Heart Center, PC

Huntsville, Alabama, United States

Site Status

Mulberry Medical Associates, PC

Montgomery, Alabama, United States

Site Status

Arizona Center for Clinical Research

Glendale, Arizona, United States

Site Status

Cardiovascular Consultants, Ltd.

Glendale, Arizona, United States

Site Status

Lovelace Scientific Resource, Inc.

Phoenix, Arizona, United States

Site Status

Cochise Clinical Research

Sierra Vista, Arizona, United States

Site Status

Southwest Heart

Tucson, Arizona, United States

Site Status

HealthFirst Physicians of AR, PA dba Convenient Care Clinic

Hot Springs, Arkansas, United States

Site Status

NEA Clinical

Jonesboro, Arkansas, United States

Site Status

Arkansas Primary Care Clinic, PA

Little Rock, Arkansas, United States

Site Status

Medical Investigators, Inc.

Little Rock, Arkansas, United States

Site Status

Highgrove Medical Center

Bakersfield, California, United States

Site Status

Central Cardiology Medical Clinic

Bakersfield, California, United States

Site Status

Impact Clinical Trials

Beverly Hills, California, United States

Site Status

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Site Status

Rancho Cucamonga Clinical Trials

Rancho Cucamonga, California, United States

Site Status

Pacific Heart Institute

Santa Monica, California, United States

Site Status

Los angeles biomedical research Institute at Harbor-UCLA Medical Center

Torrance, California, United States

Site Status

Aurora Denver Cardiology Associates

Aurora, Colorado, United States

Site Status

Aurora Denver Cardiology Associates

Denver, Colorado, United States

Site Status

Clinical Research of South Florida

Coral Gables, Florida, United States

Site Status

Doctors Medical center of Walton County

DeFuniak Springs, Florida, United States

Site Status

Broward General Medical Center

Fort Lauderdale, Florida, United States

Site Status

Maxine Hamilton, MD, PA

Fort Lauderdale, Florida, United States

Site Status

St John's Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Private Practice of Dr. Bridget Bellingar

Largo, Florida, United States

Site Status

A + Research Inc.

Miami, Florida, United States

Site Status

AppleMed Research, Inc.

Miami, Florida, United States

Site Status

Internal Medicine Associates of South Florida

North Miami Beach, Florida, United States

Site Status

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, Florida, United States

Site Status

Nothwest Florida Heart Group, PA-Research Dept

Pensacola, Florida, United States

Site Status

Cardiovascular Center of Sarasota

Sarasota, Florida, United States

Site Status

Suncoast Cardiovascular Research, Inc

St. Petersburg, Florida, United States

Site Status

Tampa Bay Nephrology Associates, PL

Tampa, Florida, United States

Site Status

Orlando Rangel, MD, PA

Tampa, Florida, United States

Site Status

AMR Research Associates, LLC

Bogart, Georgia, United States

Site Status

Atlanta Vascular Research Foundation

Tucker, Georgia, United States

Site Status

Consultants in Cardiovascular Med (CIS)

Melrose Park, Illinois, United States

Site Status

Illinois Heart & Lunch Research Center

Normal, Illinois, United States

Site Status

Methodist Medical Center-Heart, Lung & Vascular Institute

Peoria, Illinois, United States

Site Status

Medical consultants, PC

Muncie, Indiana, United States

Site Status

University Medical Associates

Louisville, Kentucky, United States

Site Status

Dr. Jeffrey Chen

Lafayette, Louisiana, United States

Site Status

Louisiana Research Associates, Inc.

New Orleans, Louisiana, United States

Site Status

Maine Research Associates

Auburn, Maine, United States

Site Status

PrimeCare Internal Medicine

Biddeford, Maine, United States

Site Status

Great Lakes Heart Center of Alpena

Alpena, Michigan, United States

Site Status

Internal Medicine of Northern Michigan

Petoskey, Michigan, United States

Site Status

Minneapolis VAMC

Minneapolis, Minnesota, United States

Site Status

Central Minnesota Heart Center at St. Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

St. Paul Cardiology

Saint Paul, Minnesota, United States

Site Status

Glacier View Cardiology, PC

Kalispell, Montana, United States

Site Status

Impact Clinical Trials

Las Vegas, Nevada, United States

Site Status

NJ Heart

Linden, New Jersey, United States

Site Status

New Jersey Physicians

Passaic, New Jersey, United States

Site Status

Lifeline Research Institute

Brooklyn, New York, United States

Site Status

Metrolina Internal Medicine, PA

Charlotte, North Carolina, United States

Site Status

Heart Care Center of Charlotte

Charlotte, North Carolina, United States

Site Status

Physicians East, PA

Winterville, North Carolina, United States

Site Status

Plaza Medical Group, PC

Oklahoma City, Oklahoma, United States

Site Status

Castlerock Clinical Research Consultants, LLC

Tulsa, Oklahoma, United States

Site Status

Integrated Medical Research PC

Ashland, Oregon, United States

Site Status

Blackstone Cardiology Associates

Pawtucket, Rhode Island, United States

Site Status

Charleston Cardiology

Charleston, South Carolina, United States

Site Status

Paris View Family Practice

Greenville, South Carolina, United States

Site Status

Internal Medicine of Greer

Greer, South Carolina, United States

Site Status

Scenic City Research

Cleveland, Tennessee, United States

Site Status

Southeast Texas Clinical Research Center

Beaumont, Texas, United States

Site Status

Cardiovascular Research Inst. of Dallas

Dallas, Texas, United States

Site Status

Galenos Research

Dallas, Texas, United States

Site Status

Sergio F Rovner, MD

El Paso, Texas, United States

Site Status

Salim Gopalani, MD, PA

Houston, Texas, United States

Site Status

Humayum Mirza, MD, PA

Houston, Texas, United States

Site Status

Clinical Trial Network

Houston, Texas, United States

Site Status

Houston Clinical Research Assoc.

Houston, Texas, United States

Site Status

Innovative Research of West Florida

Hurst, Texas, United States

Site Status

North Texas Medical Research

Plano, Texas, United States

Site Status

Scott & White Memorial Hospital

Temple, Texas, United States

Site Status

Fletcher Allen Health Care/University of Vermont

Burlington, Vermont, United States

Site Status

Kamlesh N Dave Cardiology

Hopewell, Virginia, United States

Site Status

WVU Physicicans of Charleston

Charleston, West Virginia, United States

Site Status

Alpha Medical Research, LLC

Madison, Wisconsin, United States

Site Status

Executive Health and Research Associates

Madison, Wisconsin, United States

Site Status

Instituto de Investigaciones Clinicas Bahia Blanca

Bahía Blanca, , Argentina

Site Status

Consultorios Medicos Privados S.A.

Buenos Aires, , Argentina

Site Status

Policlinica Bancaria "9 de Julio"

Buenos Aires, , Argentina

Site Status

Diabaid (Instituto de Asistencia Integral en Diabetes)

Ciudad de Buenos Aires, , Argentina

Site Status

MD Investigaciones

Ciudad de Buenos Aires, , Argentina

Site Status

Instituto de Cardiologia de Corrientes

Corrientes, , Argentina

Site Status

Framingham Centro Medico

La Plata, , Argentina

Site Status

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, , Argentina

Site Status

Instituto de Investigaciones Clinicas de Quilmes

Quilmes, , Argentina

Site Status

Instituto de Investigaciones Clinicas

Rosario, , Argentina

Site Status

Centro de Investigaciones clincas de Litoral

Santa Fe, , Argentina

Site Status

Flinders Medical Centre

Bedford, , Australia

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Royal Perth Hospital

Perth, , Australia

Site Status

Private Practice of Dr. Herwig Van Aerde

Rio de Janeiro, , Brazil

Site Status

Countries

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United States Argentina Australia Brazil

Related Links

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Other Identifiers

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Protocol DAR-312-E

Identifier Type: -

Identifier Source: org_study_id

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