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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00330369
First received: May 24, 2006
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Darusentan
Drug: Darusentan Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
  • Percentage of subjects to reach systolic blood pressure goal [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]

Enrollment: 352
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Darusentan administered orally once daily
Other Name: LU 135252
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily
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
Darusentan administered orally once daily
Other Name: LU 135252
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily
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
Darusentan administered orally once daily
Other Name: LU 135252
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330369

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

Additional Information:
No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00330369     History of Changes
Other Study ID Numbers: DAR-311
Study First Received: May 24, 2006
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014