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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Darusentan (Drug); Guanfacine (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Gilead Sciences

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.

Clinical Details

Official title: A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects With Resistant Hypertension Despite Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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

Percentage of subjects who reach systolic blood pressure goal

Change from baseline in estimated glomerular filtration rate (eGFR)

Secondary outcome: Change from baseline in trough sitting systolic and diastolic blood pressures

Eligibility

Minimum age: 35 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

SELECTED 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. SELECTED 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.

Locations and Contacts

Instituto de Investigaciones Clinicas Bahia Blanca, Bahia Blanca, Argentina

Consultorios Medicos Privados S.A., Buenos Aires, Argentina

Policlinica Bancaria "9 de Julio", Buenos Aires, Argentina

Diabaid (Instituto de Asistencia Integral en Diabetes), Ciudad de Buenos Aires, Argentina

MD Investigaciones, Ciudad de Buenos Aires, Argentina

Instituto de Cardiologia de Corrientes, Corrientes, Argentina

Framingham Centro Medico, La Plata, Argentina

Instituto de Investigaciones Clinicas Mar del Plata, Mar del Plata, Argentina

Instituto de Investigaciones Clinicas de Quilmes, Quilmes, Argentina

Instituto de Investigaciones Clinicas, Rosario, Argentina

Centro de Investigaciones clincas de Litoral, Santa Fe, Argentina

Flinders Medical Centre, Bedford, Australia

Royal Perth Hospital, Perth, Australia

Private Practice of Dr. Herwig Van Aerde, Rio de Janeiro, Brazil

Alabama Internal Medicine, PC, Birmingham, Alabama 35235, United States

Greystone Medical Research, LLC, Birmingham, Alabama 35242, United States

The Heart Center, PC, Huntsville, Alabama 35801, United States

Mulberry Medical Associates, PC, Montgomery, Alabama 36106, United States

Arizona Center for Clinical Research, Glendale, Arizona 85306, United States

Cardiovascular Consultants, Ltd., Glendale, Arizona 85306, United States

Lovelace Scientific Resource, Inc., Phoenix, Arizona 85016, United States

Cochise Clinical Research, Sierra Vista, Arizona 85635, United States

Southwest Heart, Tucson, Arizona 85715, United States

HealthFirst Physicians of AR, PA dba Convenient Care Clinic, Hot Springs, Arkansas 71913, United States

NEA Clinical, Jonesboro, Arkansas 72401, United States

Arkansas Primary Care Clinic, PA, Little Rock, Arkansas 72204, United States

Medical Investigators, Inc., Little Rock, Arkansas 72205, United States

Central Cardiology Medical Clinic, Bakersfield, California 93308, United States

Highgrove Medical Center, Bakersfield, California 93301, United States

Impact Clinical Trials, Beverly Hills, California 90211, United States

VA Greater Los Angeles Healthcare System, Los Angeles, California 90073, United States

Rancho Cucamonga Clinical Trials, Rancho Cucamonga, California 91730, United States

Pacific Heart Institute, Santa Monica, California 90404, United States

Los angeles biomedical research Institute at Harbor-UCLA Medical Center, Torrance, California 90502, United States

Aurora Denver Cardiology Associates, Aurora, Colorado 80012, United States

Aurora Denver Cardiology Associates, Denver, Colorado 80218, United States

Clinical Research of South Florida, Coral Gables, Florida 33134, United States

Doctors Medical center of Walton County, Defuniak Springs, Florida 32435, United States

Broward General Medical Center, Fort Lauderdale, Florida 33316, United States

Maxine Hamilton, MD, PA, Ft Lauderdale, Florida 33316, United States

St John's Center for Clinical Research, Jacksonville, Florida 32259, United States

Private Practice of Dr. Bridget Bellingar, Largo, Florida 33773, United States

A + Research Inc., Miami, Florida 33144, United States

AppleMed Research, Inc., Miami, Florida 33155, United States

Internal Medicine Associates of South Florida, N. Miami Beach, Florida 33179, United States

Ormond Medical Arts Pharmaceutical Research Center, Ormond Beach, Florida 32174, United States

Nothwest Florida Heart Group, PA-Research Dept, Pensacola, Florida 32514, United States

Cardiovascular Center of Sarasota, Sarasota, Florida 34231, United States

Suncoast Cardiovascular Research, Inc, St Petersburg, Florida 33701, United States

Orlando Rangel, MD, PA, Tampa, Florida 33607, United States

Tampa Bay Nephrology Associates, PL, Tampa, Florida 33603, United States

AMR Research Associates, LLC, Bogart, Georgia 30622, United States

Atlanta Vascular Research Foundation, Tucker, Georgia 30084, United States

Consultants in Cardiovascular Med (CIS), Melrose Park, Illinois 60160, United States

Illinois Heart & Lunch Research Center, Normal, Illinois 61761, United States

Methodist Medical Center-Heart, Lung & Vascular Institute, Peoria, Illinois 61606, United States

Medical consultants, PC, Muncie, Indiana 47303, United States

University Medical Associates, Louisville, Kentucky 40202, United States

Dr. Jeffrey Chen, Lafayette, Louisiana 70503, United States

Louisiana Research Associates, Inc., New Orleans, Louisiana 70114, United States

Maine Research Associates, Auburn, Maine 04210, United States

PrimeCare Internal Medicine, Biddeford, Maine 04005, United States

Great Lakes Heart Center of Alpena, Alpena, Michigan 49707, United States

Internal Medicine of Northern Michigan, Petoskey, Michigan 49770, United States

Minneapolis VAMC, Minneapolis, Minnesota 55417, United States

Central Minnesota Heart Center at St. Cloud Hospital, St. Cloud, Minnesota 56303, United States

St. Paul Cardiology, St. Paul, Minnesota 55102, United States

Glacier View Cardiology, PC, Kalispell, Montana 59901, United States

Impact Clinical Trials, Las Vegas, Nevada 89106, United States

NJ Heart, Linden, New Jersey 07036, United States

New Jersey Physicians, Passaic, New Jersey 07055, United States

Lifeline Research Institute, Brooklyn, New York 11214, United States

Heart Care Center of Charlotte, Charlotte, North Carolina 28211, United States

Metrolina Internal Medicine, PA, Charlotte, North Carolina 28204, United States

Physicians East, PA, Winterville, North Carolina 27858, United States

Plaza Medical Group, PC, Oklahoma City, Oklahoma 73112, United States

Castlerock Clinical Research Consultants, LLC, Tulsa, Oklahoma 74136, United States

Integrated Medical Research PC, Ashland, Oregon 97520, United States

Blackstone Cardiology Associates, Pawtucket, Rhode Island 02860, United States

Charleston Cardiology, Charleston, South Carolina 29403, United States

Paris View Family Practice, Greenville, South Carolina 29601, United States

Internal Medicine of Greer, Greer, South Carolina 29651, United States

Scenic City Research, Cleveland, Tennessee 37311, United States

Southeast Texas Clinical Research Center, Beaumont, Texas 77702, United States

Cardiovascular Research Inst. of Dallas, Dallas, Texas 75231, United States

Galenos Research, Dallas, Texas 75251, United States

Sergio F Rovner, MD, El Paso, Texas 79935, United States

Clinical Trial Network, Houston, Texas 77074, United States

Houston Clinical Research Assoc., Houston, Texas 77090, United States

Humayum Mirza, MD, PA, Houston, Texas 77055, United States

Salim Gopalani, MD, PA, Houston, Texas 77008, United States

Innovative Research of West Florida, Hurst, Texas 76054, United States

North Texas Medical Research, Plano, Texas 75093, United States

Scott & White Memorial Hospital, Temple, Texas 76508, United States

Fletcher Allen Health Care/University of Vermont, Burlington, Vermont 05401, United States

Kamlesh N Dave Cardiology, Hopewell, Virginia 23860, United States

WVU Physicicans of Charleston, Charleston, West Virginia 25304, United States

Alpha Medical Research, LLC, Madison, Wisconsin 43717, United States

Executive Health and Research Associates, Madison, Wisconsin 53717, United States

Additional Information

Starting date: May 2007
Last updated: January 3, 2014

Page last updated: August 23, 2015

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