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HypertensionPhase 3DarusentanNCT00389675

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

A Phase 3 study testing Darusentan and Guanfacine in people with Hypertension, run by Gilead Sciences at 99 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Hypertension
What is being tested?
Darusentan and Guanfacine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
661 participants
Where
99 sitesin 4 countries
Study dates
May 2007to May 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

99 sites in 4 countries.

99 sites in 4 countries

United States85 sites

  • Great Lakes Heart Center of Alpena

    Alpena, Michigan, 49707

  • Integrated Medical Research PC

    Ashland, Oregon, 97520

  • Maine Research Associates

    Auburn, Maine, 04210

  • Aurora Denver Cardiology Associates

    Aurora, Colorado, 80012

  • Highgrove Medical Center

    Bakersfield, California, 93301

  • Central Cardiology Medical Clinic

    Bakersfield, California, 93308

  • Southeast Texas Clinical Research Center

    Beaumont, Texas, 77702

  • Impact Clinical Trials

    Beverly Hills, California, 90211

  • PrimeCare Internal Medicine

    Biddeford, Maine, 04005

  • Alabama Internal Medicine, PC

    Birmingham, Alabama, 35235

  • Greystone Medical Research, LLC

    Birmingham, Alabama, 35242

  • AMR Research Associates, LLC

    Bogart, Georgia, 30622

  • Lifeline Research Institute

    Brooklyn, New York, 11214

  • Fletcher Allen Health Care/University of Vermont

    Burlington, Vermont, 05401

  • Charleston Cardiology

    Charleston, South Carolina, 29403

  • WVU Physicicans of Charleston

    Charleston, West Virginia, 25304

  • Metrolina Internal Medicine, PA

    Charlotte, North Carolina, 28204

  • Heart Care Center of Charlotte

    Charlotte, North Carolina, 28211

  • Scenic City Research

    Cleveland, Tennessee, 37311

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Cardiovascular Research Inst. of Dallas

    Dallas, Texas, 75231

  • Galenos Research

    Dallas, Texas, 75251

  • Doctors Medical center of Walton County

    DeFuniak Springs, Florida, 32435

  • Aurora Denver Cardiology Associates

    Denver, Colorado, 80218

  • Sergio F Rovner, MD

    El Paso, Texas, 79935

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Maxine Hamilton, MD, PA

    Fort Lauderdale, Florida, 33316

  • Arizona Center for Clinical Research

    Glendale, Arizona, 85306

  • Cardiovascular Consultants, Ltd.

    Glendale, Arizona, 85306

  • Paris View Family Practice

    Greenville, South Carolina, 29601

  • Internal Medicine of Greer

    Greer, South Carolina, 29651

  • Kamlesh N Dave Cardiology

    Hopewell, Virginia, 23860

  • HealthFirst Physicians of AR, PA dba Convenient Care Clinic

    Hot Springs, Arkansas, 71913

  • Salim Gopalani, MD, PA

    Houston, Texas, 77008

  • Humayum Mirza, MD, PA

    Houston, Texas, 77055

  • Clinical Trial Network

    Houston, Texas, 77074

  • Houston Clinical Research Assoc.

    Houston, Texas, 77090

  • The Heart Center, PC

    Huntsville, Alabama, 35801

  • Innovative Research of West Florida

    Hurst, Texas, 76054

  • St John's Center for Clinical Research

    Jacksonville, Florida, 32259

  • NEA Clinical

    Jonesboro, Arkansas, 72401

  • Glacier View Cardiology, PC

    Kalispell, Montana, 59901

  • Dr. Jeffrey Chen

    Lafayette, Louisiana, 70503

  • Private Practice of Dr. Bridget Bellingar

    Largo, Florida, 33773

  • Impact Clinical Trials

    Las Vegas, Nevada, 89106

  • NJ Heart

    Linden, New Jersey, 07036

  • Arkansas Primary Care Clinic, PA

    Little Rock, Arkansas, 72204

  • Medical Investigators, Inc.

    Little Rock, Arkansas, 72205

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • University Medical Associates

    Louisville, Kentucky, 40202

  • Alpha Medical Research, LLC

    Madison, Wisconsin, 43717

  • Executive Health and Research Associates

    Madison, Wisconsin, 53717

  • Consultants in Cardiovascular Med (CIS)

    Melrose Park, Illinois, 60160

  • A + Research Inc.

    Miami, Florida, 33144

  • AppleMed Research, Inc.

    Miami, Florida, 33155

  • Minneapolis VAMC

    Minneapolis, Minnesota, 55417

  • Mulberry Medical Associates, PC

    Montgomery, Alabama, 36106

  • Medical consultants, PC

    Muncie, Indiana, 47303

  • Louisiana Research Associates, Inc.

    New Orleans, Louisiana, 70114

  • Illinois Heart & Lunch Research Center

    Normal, Illinois, 61761

  • Internal Medicine Associates of South Florida

    North Miami Beach, Florida, 33179

  • Plaza Medical Group, PC

    Oklahoma City, Oklahoma, 73112

  • Ormond Medical Arts Pharmaceutical Research Center

    Ormond Beach, Florida, 32174

  • New Jersey Physicians

    Passaic, New Jersey, 07055

  • Blackstone Cardiology Associates

    Pawtucket, Rhode Island, 02860

  • Nothwest Florida Heart Group, PA-Research Dept

    Pensacola, Florida, 32514

  • Methodist Medical Center-Heart, Lung & Vascular Institute

    Peoria, Illinois, 61606

  • Internal Medicine of Northern Michigan

    Petoskey, Michigan, 49770

  • Lovelace Scientific Resource, Inc.

    Phoenix, Arizona, 85016

  • North Texas Medical Research

    Plano, Texas, 75093

  • Rancho Cucamonga Clinical Trials

    Rancho Cucamonga, California, 91730

  • Central Minnesota Heart Center at St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • St. Paul Cardiology

    Saint Paul, Minnesota, 55102

  • Pacific Heart Institute

    Santa Monica, California, 90404

  • Cardiovascular Center of Sarasota

    Sarasota, Florida, 34231

  • Cochise Clinical Research

    Sierra Vista, Arizona, 85635

  • Suncoast Cardiovascular Research, Inc

    St. Petersburg, Florida, 33701

  • Tampa Bay Nephrology Associates, PL

    Tampa, Florida, 33603

  • Orlando Rangel, MD, PA

    Tampa, Florida, 33607

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Los angeles biomedical research Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Atlanta Vascular Research Foundation

    Tucker, Georgia, 30084

  • Southwest Heart

    Tucson, Arizona, 85715

  • Castlerock Clinical Research Consultants, LLC

    Tulsa, Oklahoma, 74136

  • Physicians East, PA

    Winterville, North Carolina, 27858

Other trials in United States

Argentina11 sites

  • Instituto de Investigaciones Clinicas Bahia Blanca

    Bahía Blanca

  • Consultorios Medicos Privados S.A.

    Buenos Aires

  • Policlinica Bancaria "9 de Julio"

    Buenos Aires

  • Diabaid (Instituto de Asistencia Integral en Diabetes)

    Ciudad de Buenos Aires

  • MD Investigaciones

    Ciudad de Buenos Aires

  • Instituto de Cardiologia de Corrientes

    Corrientes

  • Framingham Centro Medico

    La Plata

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata

  • Instituto de Investigaciones Clinicas de Quilmes

    Quilmes

  • Instituto de Investigaciones Clinicas

    Rosario

  • Centro de Investigaciones clincas de Litoral

    Santa Fe

Other trials in Argentina

Australia2 sites

  • Flinders Medical Centre

    Bedford

  • Royal Perth Hospital

    Perth

Other trials in Australia

Brazil1 site

  • Private Practice of Dr. Herwig Van Aerde

    Rio de Janeiro

Other trials in Brazil

About this study

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)

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
Being tested
Darusentan, Guanfacine
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DarusentanDrug

    Also called LU 135252

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

  • GuanfacineDrug

    Guanfacine 1 mg capsules administered orally once daily

Study groups in NCT00389675
Study groupRoleWhat they receive
DarusentanExperimentalDarusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily
Receives: Drug: Darusentan
GuanfacineActive comparatorGuanfacine 1 mg capsules administered orally once daily
Receives: Drug: Guanfacine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline to Week 14

  2. Percentage of subjects who reach systolic blood pressure goal

    Measured: Week 14

  3. Change from baseline in estimated glomerular filtration rate (eGFR)

    Measured: Baseline to Week 14

Secondary outcomes (1)

  1. Change from baseline in trough sitting systolic and diastolic blood pressures

    Measured: Baseline to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2006 (estimated)
  2. Study startMay 2007
  3. Primary completionFeb 2010
  4. Study completionMay 2010

Why it stopped: Study DAR-312 did not meet its primary co-endpoints.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
661 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389675
Sponsor's protocol ID
Protocol DAR-312-E
Acronym
Darusentan
Status last verified
Jan 2014
First submitted
17 Oct 2006
Last updated
6 Jan 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darusentan and Guanfacine in people with Hypertension, run by Gilead Sciences at 99 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Argentina, Australia, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study DAR-312 did not meet its primary co-endpoints.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure (time frame: Baseline to Week 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.

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