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

NCT00389675 | Terminated Phase 3 DMC

• 1 other identifier: Protocol DAR-312-E
• Study Type: interventional
• Target: 661
• Locations: 4 countries
• Sites: 99

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure

  Baseline to Week 14

• Percentage of subjects who reach systolic blood pressure goal

  Week 14

• Change from baseline in estimated glomerular filtration rate (eGFR)

  Baseline to Week 14

Secondary Outcomes (1)

• Change from baseline in trough sitting systolic and diastolic blood pressures

  Baseline to Week 14

Study Arms (2)

Darusentan

EXPERIMENTAL

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

Drug: Darusentan

Guanfacine

ACTIVE COMPARATOR

Guanfacine 1 mg capsules administered orally once daily

Drug: Guanfacine

Interventions

Darusentan DRUG

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

Also known as: LU 135252

Darusentan

Guanfacine DRUG

Guanfacine 1 mg capsules administered orally once daily

Guanfacine

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

You may not qualify if:

• 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;
• Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (99)

Alabama Internal Medicine, PC

Birmingham, Alabama, 35235, United States

Location

Greystone Medical Research, LLC

Birmingham, Alabama, 35242, United States

Location

The Heart Center, PC

Huntsville, Alabama, 35801, United States

Location

Mulberry Medical Associates, PC

Montgomery, Alabama, 36106, United States

Location

Arizona Center for Clinical Research

Glendale, Arizona, 85306, United States

Location

Cardiovascular Consultants, Ltd.

Glendale, Arizona, 85306, United States

Location

Lovelace Scientific Resource, Inc.

Phoenix, Arizona, 85016, United States

Location

Cochise Clinical Research

Sierra Vista, Arizona, 85635, United States

Location

Southwest Heart

Tucson, Arizona, 85715, United States

Location

HealthFirst Physicians of AR, PA dba Convenient Care Clinic

Hot Springs, Arkansas, 71913, United States

Location

NEA Clinical

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Primary Care Clinic, PA

Little Rock, Arkansas, 72204, United States

Location

Medical Investigators, Inc.

Little Rock, Arkansas, 72205, United States

Location

Highgrove Medical Center

Bakersfield, California, 93301, United States

Location

Central Cardiology Medical Clinic

Bakersfield, California, 93308, United States

Location

Impact Clinical Trials

Beverly Hills, California, 90211, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Rancho Cucamonga Clinical Trials

Rancho Cucamonga, California, 91730, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Los angeles biomedical research Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Aurora Denver Cardiology Associates

Aurora, Colorado, 80012, United States

Location

Aurora Denver Cardiology Associates

Denver, Colorado, 80218, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Doctors Medical center of Walton County

DeFuniak Springs, Florida, 32435, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Maxine Hamilton, MD, PA

Fort Lauderdale, Florida, 33316, United States

Location

St John's Center for Clinical Research

Jacksonville, Florida, 32259, United States

Location

Private Practice of Dr. Bridget Bellingar

Largo, Florida, 33773, United States

Location

A + Research Inc.

Miami, Florida, 33144, United States

Location

AppleMed Research, Inc.

Miami, Florida, 33155, United States

Location

Internal Medicine Associates of South Florida

North Miami Beach, Florida, 33179, United States

Location

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, Florida, 32174, United States

Location

Nothwest Florida Heart Group, PA-Research Dept

Pensacola, Florida, 32514, United States

Location

Cardiovascular Center of Sarasota

Sarasota, Florida, 34231, United States

Location

Suncoast Cardiovascular Research, Inc

St. Petersburg, Florida, 33701, United States

Location

Tampa Bay Nephrology Associates, PL

Tampa, Florida, 33603, United States

Location

Orlando Rangel, MD, PA

Tampa, Florida, 33607, United States

Location

AMR Research Associates, LLC

Bogart, Georgia, 30622, United States

Location

Atlanta Vascular Research Foundation

Tucker, Georgia, 30084, United States

Location

Consultants in Cardiovascular Med (CIS)

Melrose Park, Illinois, 60160, United States

Location

Illinois Heart & Lunch Research Center

Normal, Illinois, 61761, United States

Location

Methodist Medical Center-Heart, Lung & Vascular Institute

Peoria, Illinois, 61606, United States

Location

Medical consultants, PC

Muncie, Indiana, 47303, United States

Location

University Medical Associates

Louisville, Kentucky, 40202, United States

Location

Dr. Jeffrey Chen

Lafayette, Louisiana, 70503, United States

Location

Louisiana Research Associates, Inc.

New Orleans, Louisiana, 70114, United States

Location

Maine Research Associates

Auburn, Maine, 04210, United States

Location

PrimeCare Internal Medicine

Biddeford, Maine, 04005, United States

Location

Great Lakes Heart Center of Alpena

Alpena, Michigan, 49707, United States

Location

Internal Medicine of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

Location

Central Minnesota Heart Center at St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

St. Paul Cardiology

Saint Paul, Minnesota, 55102, United States

Location

Glacier View Cardiology, PC

Kalispell, Montana, 59901, United States

Location

Impact Clinical Trials

Las Vegas, Nevada, 89106, United States

Location

NJ Heart

Linden, New Jersey, 07036, United States

Location

New Jersey Physicians

Passaic, New Jersey, 07055, United States

Location

Lifeline Research Institute

Brooklyn, New York, 11214, United States

Location

Metrolina Internal Medicine, PA

Charlotte, North Carolina, 28204, United States

Location

Heart Care Center of Charlotte

Charlotte, North Carolina, 28211, United States

Location

Physicians East, PA

Winterville, North Carolina, 27858, United States

Location

Plaza Medical Group, PC

Oklahoma City, Oklahoma, 73112, United States

Location

Castlerock Clinical Research Consultants, LLC

Tulsa, Oklahoma, 74136, United States

Location

Integrated Medical Research PC

Ashland, Oregon, 97520, United States

Location

Blackstone Cardiology Associates

Pawtucket, Rhode Island, 02860, United States

Location

Charleston Cardiology

Charleston, South Carolina, 29403, United States

Location

Paris View Family Practice

Greenville, South Carolina, 29601, United States

Location

Internal Medicine of Greer

Greer, South Carolina, 29651, United States

Location

Scenic City Research

Cleveland, Tennessee, 37311, United States

Location

Southeast Texas Clinical Research Center

Beaumont, Texas, 77702, United States

Location

Cardiovascular Research Inst. of Dallas

Dallas, Texas, 75231, United States

Location

Galenos Research

Dallas, Texas, 75251, United States

Location

Sergio F Rovner, MD

El Paso, Texas, 79935, United States

Location

Salim Gopalani, MD, PA

Houston, Texas, 77008, United States

Location

Humayum Mirza, MD, PA

Houston, Texas, 77055, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Houston Clinical Research Assoc.

Houston, Texas, 77090, United States

Location

Innovative Research of West Florida

Hurst, Texas, 76054, United States

Location

North Texas Medical Research

Plano, Texas, 75093, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Fletcher Allen Health Care/University of Vermont

Burlington, Vermont, 05401, United States

Location

Kamlesh N Dave Cardiology

Hopewell, Virginia, 23860, United States

Location

WVU Physicicans of Charleston

Charleston, West Virginia, 25304, United States

Location

Alpha Medical Research, LLC

Madison, Wisconsin, 43717, United States

Location

Executive Health and Research Associates

Madison, Wisconsin, 53717, United States

Location

Instituto de Investigaciones Clinicas Bahia Blanca

Bahía Blanca, Argentina

Location

Consultorios Medicos Privados S.A.

Buenos Aires, Argentina

Location

Policlinica Bancaria "9 de Julio"

Buenos Aires, Argentina

Location

Diabaid (Instituto de Asistencia Integral en Diabetes)

Ciudad de Buenos Aires, Argentina

Location

MD Investigaciones

Ciudad de Buenos Aires, Argentina

Location

Instituto de Cardiologia de Corrientes

Corrientes, Argentina

Location

Framingham Centro Medico

La Plata, Argentina

Location

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Argentina

Location

Instituto de Investigaciones Clinicas de Quilmes

Quilmes, Argentina

Location

Instituto de Investigaciones Clinicas

Rosario, Argentina

Location

Centro de Investigaciones clincas de Litoral

Santa Fe, Argentina

Location

Flinders Medical Centre

Bedford, Australia

Location

Royal Perth Hospital

Perth, Australia

Location

Private Practice of Dr. Herwig Van Aerde

Rio de Janeiro, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension

Interventions

darusentan; Guanfacine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

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: October 17, 2006
• First Posted: October 19, 2006
• Study Start: May 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

AR (11); BR (1); AU (2); US (85)