DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension

February 19, 2014 updated by: Gilead Sciences

DORADO - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311)

This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the U.S. Food and Drug Administration (FDA) for use in the United States, which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of three or more antihypertensive drugs, including a diuretic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

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
      • Buenos Aires, Argentina
        • CIMEL
      • Buenos Aires, Argentina
        • DIM (Clinica Privada)
      • Buenos Aires, Argentina
        • Fundapres
      • Buenos Aires, Argentina
        • Hospital Británico de Buenos Aires
      • Buenos Aires, Argentina
        • Hospital Jose Maria Ramos Meijia
      • Buenos Aires, Argentina
        • Hospital Municipal bernardo Houssay
      • Buenos Aires, Argentina
        • Medeos
      • Buenos Aires, Argentina
        • Sanatorio Municipal Dr. Julio Mendez
      • Cordoba, Argentina
        • Hospital San Roque
      • Cordoba, Argentina
        • Clinica Chutro SRL
  • Brazil
      • Belo Horizonte, Brazil
        • Hospital Governador Israel Pinheiro
      • Belo Horizonte, Brazil
        • Hospital Socor
      • Campinas, Brazil
        • Centro Medico de Campinas
      • Curitiba, Brazil
        • Hospital de Clínicas da Universidade Federal do Paraná
      • Goiânia, Brazil
        • Hospital das Clínicas
      • Maceió, Brazil
        • Clinica de Exames
      • Sao Paulo, Brazil
        • Hospital das Clínicas da Faculdade de Medicina da USP
      • Sao Paulo, Brazil
        • Centro Integrado Hospital do Rim e Hipertensao
      • Sao Paulo, Brazil
        • Centro integrado hospital
      • São José do Rio Preto, Brazil
        • Instituto de Molestias
  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N3H 3R8
        • Cambridge Cardiac Care Center
      • Kitchener, Ontario, Canada, N2G 1G5
        • Clinical Research Solutions
  • Denmark
      • Hvidovre, Denmark
        • Hvidovre Hospital
      • København, Denmark
        • Bispebjerg Hospital
  • France
      • Dommartin les Toul, France
        • CIC Hopital Jeanne D'Arc
      • Grenoble Cedex, France
        • Chu de Grenoble
      • Marseille Cedex, France
        • CHU la Timone Service de cardiologie
      • Roubaix, France
        • CHU Victor Provo
      • Strasbourg Cedex, France
        • Hôpital Civil, Service HTA maladies vasculaires
  • Germany
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik Forschungs GmbH
      • Berlin, Germany
        • Charite Campus Buch
      • Cloppenburg, Germany
        • St Josefs-Hospital
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Lübeck, Germany
        • Universitätsklinikum Schleswig-Holstein
  • Italy
      • Padua, Italy
        • Azienda Ospedaliera University of Padua Policlinico
  • Spain
      • Barcelona, Spain
        • Hospital Del Mar
      • Barcelona, Spain
        • Hospital Clinic I Provincial
      • Barcelona, Spain
        • Fundacio Puigvert
      • Coruña, Spain
        • Hospital Universitario de Santiago
      • Granada, Spain
        • Hospital Clínico San Cecilio
      • Madrid, Spain
        • Hospital Clinico de San Carlos
      • Madrid, Spain
        • Hospital Universitario 12 de Octobre
      • Malaga, Spain
        • Hospital Carlos Haya
  • Sweden
      • Stockholm, Sweden
        • Cardiovascular Research, Karolinska Institue
  • United Kingdom
      • Bolton,, United Kingdom
        • Stonehill Medical Centre
      • Scotland, United Kingdom
        • Townhead Surgery
      • Wiltshire, United Kingdom
        • Avenue Surgery
      • Wiltshire, United Kingdom
        • Hathaway Medical Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Hypertension Program
      • Mobile, Alabama, United States, 36608
        • Comprehensive Heart Failure Center
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Canyon Clinical Research
    • California
      • Inglewood, California, United States, 90301
        • Chrishard Medical Group
      • Los Angeles, California, United States, 90073
        • VA Medical Center - WLA
      • Sacramento, California, United States, 95825
        • Sacramento Heart and Vascular
      • Santa Ana, California, United States, 92705
        • Apex Research Institute
    • Colorado
      • Denver, Colorado, United States, 80220
        • Complete Renal Care
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Connecticut Clinical Research, Llc
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Diabetes Institute at Washington Hospital Center
    • Florida
      • Deerfield Beach, Florida, United States, 33442
        • Deerfield Beach Cardiology Associates
      • Fort Walton Beach, Florida, United States, 32569
        • White-Wilson Medical Center
      • Gainsville, Florida, United States, 32601
        • AMK Research
      • Hialeah, Florida, United States, 33012
        • A.G.A. Clinical Trials
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical
      • Jupiter, Florida, United States, 33458
        • Ricardo A. Bedoya, Cardiology
      • Miami, Florida, United States, 33156
        • International Research Association
      • Sarasota, Florida, United States, 34239
        • Cardiovascular Center of Sarasota
      • Tampa, Florida, United States, 33603
        • Tampa Bay Nephrology
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
    • Georgia
      • Calhoun, Georgia, United States, 30701
        • Global Research Partners
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Kula Research
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Chicago Heart & Vein Clinic
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare
      • Gurnee, Illinois, United States, 60031
        • Clinical Investigation Specialists, Inc.
      • Lombard, Illinois, United States, 60148
        • Midwest Heart Foundation
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • American Clinical Research LLC
      • Slidell, Louisiana, United States, 70458
        • Medical Research Institute
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates
      • Scarborough, Maine, United States, 04074
        • Cardiovascular Consultants of Maine
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • MODEL Clinical Research
      • Oxon Hill, Maryland, United States, 20745
        • Maryland Medical Research/Og Medical Center
      • Reisterstown, Maryland, United States, 21136
        • Clinical Associates
      • Rockville, Maryland, United States, 20854
        • Rockville Internal Medicine Group
    • Michigan
      • Benzonia, Michigan, United States, 49616
        • Professional Clinical Research
      • Flint, Michigan, United States, 48503
        • Nephrology and Hypertension / Hurley Medical Center
      • Interlochen, Michigan, United States, 49643
        • Professional Clinical Research
    • Nevada
      • Pahrump, Nevada, United States, 89048
        • Specialty Medical Center
    • New York
      • Bronx, New York, United States, 10468
        • Bronx VA Medical Center / Mt. Sinai
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Physicians East, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Clinical Trial Center
      • Fairview Park, Ohio, United States, 44125
        • West Coast Cardiology Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
      • Oklahoma City, Oklahoma, United States, 73003
        • COR Clinical Research
      • Oklahoma City, Oklahoma, United States, 73109
        • Southwest Cardiology Associates
      • Tulsa, Oklahoma, United States, 74136
        • Castlerock Clinical Research Consultants
    • Oregon
      • Hillsboro, Oregon, United States, 97123
        • Hillsboro Cardiology, PC
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Northeast Clinical Research Centers, Inc.
      • Camp Hill, Pennsylvania, United States, 17011
        • Heritage Cardiology Associates
      • Downingtown, Pennsylvania, United States, 19335
        • Brandywine Clinical Research
      • Lansdale, Pennsylvania, United States, 19446
        • Green and Seidner Family Practice Associates
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • RI Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Neem Research Group, Inc.
    • Texas
      • Desoto, Texas, United States, 75115
        • Internal Medicine & Industrial Medicine
      • Ft Worth, Texas, United States, 76117
        • T&R Clinical, P.A.
      • Lewisville, Texas, United States, 75067
        • Pri-Med Care
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center
      • Midland, Texas, United States, 79705
        • Diabetes Center of the Southwest
      • Plano, Texas, United States, 75093
        • The Bracane Company
      • San Antonio, Texas, United States, 78229
        • Innovative Clinical Trials
    • Virginia
      • Burke, Virginia, United States, 22015
        • Burke Internal Medicine, Inc.
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
      • Richmond, Virginia, United States, 22015
        • McGuire VA Medical Center
    • Washington
      • Gig Harbor, Washington, United States, 98335
        • Peninsula Inernal Medicine
      • Tacoma, Washington, United States, 98405
        • Liberty Research Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials Center

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

Inclusion Criteria:

  • Subjects who are competent to provide written consent
  • Aged 35 to 80 years
  • Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmHg
  • All other subjects must have a mean systolic blood pressure ≥140 mmHg
  • Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
  • Female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)

Exclusion Criteria:

  • Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
  • Serum ALT or AST >2 x the upper limit of the normal range (ULN)
  • Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (CVA) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
  • Implanted pacemakers or implanted cardioverter defibrillator (ICD)
  • Symptomatic congestive heart failure requiring treatment
  • Hemodynamically significant valvular heart disease
  • Type I diabetes mellitus
  • Hemodialysis or peritoneal dialysis; or history of renal transplant
  • Diagnosis or recurrence of malignancy within the past 3 years
  • Sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90%
  • Subjects who perform alternating shift or night work
  • Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening

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
Placebo Comparator: Darusentan Placebo
Placebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily
Experimental: Darusentan 50 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily
Drug: Darusentan
Darusentan administered orally once daily
Other Names:
  • LU 135252
Experimental: Darusentan 100 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily
Drug: Darusentan
Darusentan administered orally once daily
Other Names:
  • LU 135252
Experimental: Darusentan 300 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily
Drug: Darusentan
Darusentan administered orally once daily
Other Names:
  • LU 135252

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry
Time Frame: Baseline to Week 14
Baseline to Week 14

Secondary 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
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
Time Frame: Baseline to Week 14
Baseline to Week 14
Percentage of subjects to reach systolic blood pressure goal
Time Frame: Week 14
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.

General Publications

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

June 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

May 24, 2006

First Submitted That Met QC Criteria

May 24, 2006

First Posted (Estimate)

May 26, 2006

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAR-311

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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