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HypertensionPhase 3DarusentanNCT00389779

DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension

A Phase 3 study testing Darusentan and Guanfacine in people with Hypertension, run by Gilead Sciences at 147 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. Darusentan is 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?
Yes, some participants may receive a placebo
How many people
849 participants
Where
147 sitesin 10 countries
Study dates
Sep 2006to Aug 2009
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 who are competent to provide written consent;
  2. Aged 35 to 80 years;
  3. Subjects with diabetes and/or chronic kidney disease must have an average sitting systolic blood pressure greater than or equal to 130 mmHg;
  4. All other subjects must have an average sitting systolic blood pressure greater than or equal to 140 mmHg;
  5. Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic;
  6. Female subjects of non-childbearing potential (i.e., post-menopausal for at least 2 years or surgically sterile).

SELECTED EXCLUSION CRITERIA:

  1. Average sitting systolic and diastolic blood pressure greater than or equal to 180 mmHg and 110 mmHg, respectively;
  2. Subjects treated with a central alpha-2 agonist and/or imidazoline receptor agonist;
  3. Left ventricular dysfunction;
  4. Serum ALT or AST greater than 2 times the Upper Limit of Normal;
  5. Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachycardia, recurrent ventricular tachycardia, or symptomatic bradycardia;
  6. Implanted pacemakers or cardioverter defibrillator;
  7. Symptomatic congestive heart failure requiring treatment;
  8. Hemodynamically significant valvular heart disease;
  9. Hemodialysis or peritoneal dialysis, or history of renal transplant;
  10. Type I diabetes mellitus;
  11. Diagnosis or recurrence of malignancy within the past 3 years;
  12. Sleep apnea, unless a recent sleep study demonstrated arterial oxygenation saturation greater than or equal to 90%, treated or untreated;
  13. Subjects who perform alternating shift or night work;
  14. Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening

Trial locations and contacts

147 sites in 10 countries.

147 sites in 10 countries

United States87 sites

  • Great Lakes Heart Center of Alpena

    Alpena, Michigan, 49707

  • Integrated Medical Research PC

    Ashland, Oregon, 97520

  • Maine Research Associate

    Auburn, Maine, 04210

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • Aurora Denver Cardiology Associates

    Aurora, Colorado, 80012

  • Aurora Denver Cardiology Associates

    Aurora, Colorado, 80218

  • Highgrove Medical Center

    Bakersfield, California, 93301

  • Central Cardiology Medical Clinic

    Bakersfield, California, 93308

  • North Shore Cardiologist

    Bannockburn, Illinois, 60015

  • 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 Physicians 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

  • 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 Physician of AR, PA dba Convenient Care Clinic

    Hot Springs, Arkansas, 71913

  • Salim Gopalani, MD, PA

    Houston, Texas, 77008

  • Humayun 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 Clinic

    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 Investigations 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

    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

  • Northwest Florida Heart Group, PA - Research Dept

    Pensacola, Florida, 32514

  • Methodist Medical Center-Heart, Lung & Vascular Institute

    Peoria, Illinois, 61606

  • Internal Medicine of Nothern Michigan

    Petoskey, Michigan, 49770

  • Lovelace Scientific Resources, 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 Counsultants, LLC

    Tulsa, Oklahoma, 74136

  • Physicians East, PA

    Winterville, North Carolina, 27858

Other trials in United States

Argentina15 sites

  • Hospital Italiano Regional del Sur

    Bahía Blanca, Buenos Aires

  • Instituto de Investigaciones Clinicas Bahia Blanca

    Bahía Blanca, Buenos Aires

  • Consultorios Medicos Privados S.A.

    Buenos Aires

  • Hospital General de Agudos "Dr. Abel Zubizarreta"

    Buenos Aires

  • Policlinica Bancaria "9 de Julio"

    Buenos Aires

  • Centro Medico Privado

    Ciudad de

  • Diabaid (Instituto de Asistencia Integral en Diabetes)

    Ciudad de Buenos Aires

  • MD Investigaciones

    Ciudad de Buenos Aires

  • Fundacion Rusculleda

    Córdoba

  • Instituto de Cardiologia de Corrientes

    Corrientes

  • Framingham Centro Medico

    La Plata

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, Buenos Aires

  • Instituto de Investigaciones Clinicas de Quilmes

    Quilmes

  • Instituto de Investigaciones Clinicas

    Rosario

  • Centro de Investigaciones Clinicas del Litoral

    Santa Fe

Other trials in Argentina

Belgium11 sites

  • U.Z. Brussel

    Brussels

  • Private Practice of Dr. Geert Hollanders

    De Pinte

  • Private Practice of Dr. Francis Vrancken

    Genk

  • Private Practice of Dr. Herwig Van Aerde

    Genk

  • Private Practice of Dr. Willy Denier

    Genk

  • Private Practice of Dr. Herman Docx

    Hoeilaart

  • Private Practice of Dr. Yohan Balthazar

    Natoye

  • Private Practice of Dr. Sophie Baeyens

    Pulle

  • Private Practice of Dr. Jean Gilissen

    Riemst

  • Private Practice of Dr. Guido Mehuys

    Tielt

  • Private Practice of Dr. Luc Capiau

    Wetteren

Other trials in Belgium

France10 sites

  • George Delamare

    Blois

  • Centre d'Investigation Clinique

    Dommartin-lès-Toul

  • Private Practice of Dr. Brune Charrier

    La Jubaudière

  • Private Practice of Dr. Jean Boulet-Gercourt

    Le Mesnil-en-Vallée

  • Private Practice of Dr. Gildas Ganuchaud

    Le Temple-de-Bretagne

  • Private Practice of Dr. Jacques Samat

    Martigues

  • Private Practice of dr. Marty Jacques

    Mûrs-Erigné, Murs-Erigne

  • Private Practice of Dr. Alain Boye

    Nantes

  • Private Practice of Dr. Francois Volny

    Nantes

  • Private Practice of Dr. Thierry Schaupp

    Vihiers

Other trials in France

Germany10 sites

  • Private Practice of Dr. Josef Junggeburth

    Bad Wörishofen

  • Charite Campus Mitte, Universitatsmedizin Berlin

    Berlin

  • Klinische Forschung Berlin-Buch GmbH

    Berlin

  • Private Practice of Dr. Isabelle Schenkenberger

    Berlin

  • Private Practice of Dr. Tobias Marsen

    Cologne

  • PD Dr. med. Bernhard Winkelmann

    Frankfurt

  • Clinical Research Hamburg

    Hamburg

  • Dr. Med. Susanne Mindt-Prufert

    Hamburg

  • Private Practice for Internal Medicine & Cardiology

    Heidelberg

  • IFG-Institut fur Gesundheitsforderung GmbH

    Rüdersdorf

Other trials in Germany

New Zealand5 sites

  • Centre for Clinical Research and Effective Practice (CCRep)

    Auckland

  • Christchurch Hospital

    Christchurch

  • Greenlane Clinical Centre

    Greenlane

  • Cardiology Clinical Trial Unit

    Hamilton

  • Tauranga Hospital

    Tauranga

Other trials in New Zealand

Australia4 sites

  • Flinders Medical Centre

    Bedford Park

  • Royal Brisbane & Women's Hospital

    Herston

  • Alfred Hospital

    Melbourne

  • Royal Perth Hospital

    Perth

Other trials in Australia

Denmark2 sites

  • Aalborg University Hospital

    Aalborg

  • Region Sjaelland, Storstrommens Sygenhus, Naestved

    Næstved

Other trials in Denmark

Spain2 sites

  • Hospital Universitario de Bellvitge

    Barcelona

  • Hospital General Universitario de Elche

    Elche

Other trials in Spain

Brazil1 site

  • Hospital Universitario Pedro Ernesto

    Rio de Janeiro

Other trials in Brazil

About this study

Official title: A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects With Resistant Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo (Protocol DAR-312)

This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. Darusentan is 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 determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose), an active comparator, or placebo, administered orally. The treatment period for this trial is 14 weeks.

Conditions
Hypertension
Being tested
Darusentan, Guanfacine, Darusentan Placebo
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 administered orally once daily

  • GuanfacineDrug

    Guanfacine capsules administered orally once daily

  • Darusentan PlaceboDrug

    Placebo to match darusentan administered orally once daily

Study groups in NCT00389779
Study groupRoleWhat they receive
DarusentanExperimentalPlacebo to match darusentan for 2-week placebo run-in period, followed by darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily for 14 weeks
Receives: Drug: Darusentan; Drug: Darusentan Placebo
GuanfacineActive comparatorPlacebo to match darusentan for 2-week placebo run-in period, followed by guanfacine 1 mg capsules administered orally once daily for 14 weeks
Receives: Drug: Guanfacine; Drug: Darusentan Placebo
Darusentan PlaceboPlacebo comparatorPlacebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks
Receives: Drug: Darusentan Placebo

What is being measured

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

  1. Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry

    Measured: Baseline to Week 14

Secondary outcomes (3)

  1. Percentage of subjects reaching systolic blood pressure goal after 14 weeks of treatment

    Measured: Week 14

  2. Change from baseline in mean 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)

    Measured: Baseline to Week 14

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

    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 startSep 2006
  3. Primary completionAug 2009
  4. Study completionAug 2009

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
849 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389779
Sponsor's protocol ID
Protocol DAR-312
Acronym
Darusentan
Status last verified
Feb 2014
First submitted
17 Oct 2006
Last updated
18 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Bakris GL, Lindholm LH, Black HR, Krum H, Linas S, Linseman JV, Arterburn S, Sager P, Weber M. Divergent results using clinic and ambulatory blood pressures: report of a darusentan-resistant hypertension trial. Hypertension. 2010 Nov;56(5):824-30. doi: 10.1161/HYPERTENSIONAHA.110.156976. Epub 2010 Oct 4.

    PubMed 20921430

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 147 sites in 10 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: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Argentina, Belgium, France, Germany and 5 more countries. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 trough sitting systolic and diastolic blood pressure measured by sphygmomanometry (time frame: Baseline to Week 14). 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 NCT00389779, which also lists 1 linked publication.

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 18 Mar 2014.

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