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

January 3, 2014 updated by: Gilead Sciences

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

661

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina
        • Instituto de Investigaciones Clinicas Bahia Blanca
      • Buenos Aires, Argentina
        • Consultorios Medicos Privados S.A.
      • Buenos Aires, Argentina
        • Policlinica Bancaria "9 de Julio"
      • Ciudad de Buenos Aires, Argentina
        • Diabaid (Instituto de Asistencia Integral en Diabetes)
      • Ciudad de Buenos Aires, Argentina
        • MD Investigaciones
      • Corrientes, Argentina
        • Instituto de Cardiologia de Corrientes
      • La Plata, Argentina
        • Framingham Centro Medico
      • Mar del Plata, Argentina
        • Instituto de Investigaciones Clínicas Mar del Plata
      • Quilmes, Argentina
        • Instituto de Investigaciones Clinicas de Quilmes
      • Rosario, Argentina
        • Instituto de Investigaciones Clinicas
      • Santa Fe, Argentina
        • Centro de Investigaciones clincas de Litoral
  • Australia
      • Bedford, Australia
        • Flinders Medical Centre
      • Perth, Australia
        • Royal Perth Hospital
  • Brazil
      • Rio de Janeiro, Brazil
        • Private Practice of Dr. Herwig Van Aerde
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Internal Medicine, PC
      • Birmingham, Alabama, United States, 35242
        • Greystone Medical Research, LLC
      • Huntsville, Alabama, United States, 35801
        • The Heart Center, PC
      • Montgomery, Alabama, United States, 36106
        • Mulberry Medical Associates, PC
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Center For Clinical Research
      • Glendale, Arizona, United States, 85306
        • Cardiovascular Consultants, Ltd.
      • Phoenix, Arizona, United States, 85016
        • Lovelace Scientific Resource, Inc.
      • Sierra Vista, Arizona, United States, 85635
        • Cochise Clinical Research
      • Tucson, Arizona, United States, 85715
        • Southwest Heart
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • HealthFirst Physicians of AR, PA dba Convenient Care Clinic
      • Jonesboro, Arkansas, United States, 72401
        • NEA Clinical
      • Little Rock, Arkansas, United States, 72204
        • Arkansas Primary Care Clinic, PA
      • Little Rock, Arkansas, United States, 72205
        • Medical Investigators, Inc.
    • California
      • Bakersfield, California, United States, 93301
        • Highgrove Medical Center
      • Bakersfield, California, United States, 93308
        • Central Cardiology Medical Clinic
      • Beverly Hills, California, United States, 90211
        • Impact Clinical Trials
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System
      • Rancho Cucamonga, California, United States, 91730
        • Rancho Cucamonga Clinical Trials
      • Santa Monica, California, United States, 90404
        • Pacific Heart Institute
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Denver Cardiology Associates
      • Denver, Colorado, United States, 80218
        • Aurora Denver Cardiology Associates
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Defuniak Springs, Florida, United States, 32435
        • Doctors Medical center of Walton County
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center
      • Ft Lauderdale, Florida, United States, 33316
        • Maxine Hamilton, MD, PA
      • Jacksonville, Florida, United States, 32259
        • St John's Center for Clinical Research
      • Largo, Florida, United States, 33773
        • Private Practice of Dr. Bridget Bellingar
      • Miami, Florida, United States, 33155
        • AppleMed Research, Inc.
      • Miami, Florida, United States, 33144
        • A + Research Inc.
      • N. Miami Beach, Florida, United States, 33179
        • Internal Medicine Associates of South Florida
      • Ormond Beach, Florida, United States, 32174
        • Ormond Medical Arts Pharmaceutical Research Center
      • Pensacola, Florida, United States, 32514
        • Nothwest Florida Heart Group, PA-Research Dept
      • Sarasota, Florida, United States, 34231
        • Cardiovascular Center of Sarasota
      • St Petersburg, Florida, United States, 33701
        • Suncoast Cardiovascular Research, Inc
      • Tampa, Florida, United States, 33603
        • Tampa Bay Nephrology Associates, PL
      • Tampa, Florida, United States, 33607
        • Orlando Rangel, MD, PA
    • Georgia
      • Bogart, Georgia, United States, 30622
        • AMR Research Associates, LLC
      • Tucker, Georgia, United States, 30084
        • Atlanta Vascular Research Foundation
    • Illinois
      • Melrose Park, Illinois, United States, 60160
        • Consultants in Cardiovascular Med (CIS)
      • Normal, Illinois, United States, 61761
        • Illinois Heart & Lunch Research Center
      • Peoria, Illinois, United States, 61606
        • Methodist Medical Center-Heart, Lung & Vascular Institute
    • Indiana
      • Muncie, Indiana, United States, 47303
        • Medical Consultants, Pc
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University Medical Associates
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Dr. Jeffrey Chen
      • New Orleans, Louisiana, United States, 70114
        • Louisiana Research Associates, Inc.
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates
      • Biddeford, Maine, United States, 04005
        • PrimeCare Internal Medicine
    • Michigan
      • Alpena, Michigan, United States, 49707
        • Great Lakes Heart Center Of Alpena
      • Petoskey, Michigan, United States, 49770
        • Internal Medicine of Northern Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VAMC
      • St. Cloud, Minnesota, United States, 56303
        • Central Minnesota Heart Center at St. Cloud Hospital
      • St. Paul, Minnesota, United States, 55102
        • St. Paul Cardiology
    • Montana
      • Kalispell, Montana, United States, 59901
        • Glacier View Cardiology, PC
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Impact Clinical Trials
    • New Jersey
      • Linden, New Jersey, United States, 07036
        • NJ Heart
      • Passaic, New Jersey, United States, 07055
        • New Jersey Physicians
    • New York
      • Brooklyn, New York, United States, 11214
        • Lifeline Research Institute
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Metrolina Internal Medicine, PA
      • Charlotte, North Carolina, United States, 28211
        • Heart Care Center of Charlotte
      • Winterville, North Carolina, United States, 27858
        • Physicians East, PA
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Plaza Medical Group, Pc
      • Tulsa, Oklahoma, United States, 74136
        • Castlerock Clinical Research Consultants, Llc
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Integrated Medical Research PC
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Blackstone Cardiology Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Cardiology
      • Greenville, South Carolina, United States, 29601
        • Paris View Family Practice
      • Greer, South Carolina, United States, 29651
        • Internal Medicine Of Greer
    • Tennessee
      • Cleveland, Tennessee, United States, 37311
        • Scenic City Research
    • Texas
      • Beaumont, Texas, United States, 77702
        • Southeast Texas Clinical Research Center
      • Dallas, Texas, United States, 75231
        • Cardiovascular Research Inst. of Dallas
      • Dallas, Texas, United States, 75251
        • Galenos Research
      • El Paso, Texas, United States, 79935
        • Sergio F Rovner, MD
      • Houston, Texas, United States, 77008
        • Salim Gopalani, MD, PA
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77090
        • Houston Clinical Research Assoc.
      • Houston, Texas, United States, 77055
        • Humayum Mirza, MD, PA
      • Hurst, Texas, United States, 76054
        • Innovative Research of West Florida
      • Plano, Texas, United States, 75093
        • North Texas Medical Research
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care/University of Vermont
    • Virginia
      • Hopewell, Virginia, United States, 23860
        • Kamlesh N Dave Cardiology
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • WVU Physicicans of Charleston
    • Wisconsin
      • Madison, Wisconsin, United States, 43717
        • Alpha Medical Research, Llc
      • Madison, Wisconsin, United States, 53717
        • Executive Health and Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Darusentan
Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily
Drug: Darusentan
Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
Other Names:
  • LU 135252
Active Comparator: Guanfacine
Guanfacine 1 mg capsules administered orally once daily
Drug: Guanfacine
Guanfacine 1 mg capsules administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in estimated glomerular filtration rate (eGFR)
Time Frame: Baseline to Week 14
Baseline to Week 14
Percentage of subjects who reach systolic blood pressure goal
Time Frame: Week 14
Week 14
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
Time Frame: Baseline to Week 14
Baseline to Week 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in trough sitting systolic and diastolic blood pressures
Time Frame: Baseline to Week 14
Baseline to Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 18, 2006

First Posted (Estimate)

October 19, 2006

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol DAR-312-E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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