DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension
Darusentan
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)
1 other identifier
interventional
849
10 countries
147
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started Sep 2006
Longer than P75 for phase_3 hypertension
147 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 17, 2006
CompletedFirst Posted
Study publicly available on registry
October 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedMarch 18, 2014
February 1, 2014
2.9 years
October 17, 2006
February 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry
Baseline to Week 14
Secondary Outcomes (3)
Percentage of subjects reaching systolic blood pressure goal after 14 weeks of treatment
Week 14
Change from baseline in mean 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)
Baseline to Week 14
Change from baseline in estimated glomerular filtration rate (eGFR)
Baseline to Week 14
Study Arms (3)
Darusentan
EXPERIMENTALPlacebo 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
Guanfacine
ACTIVE COMPARATORPlacebo to match darusentan for 2-week placebo run-in period, followed by guanfacine 1 mg capsules administered orally once daily for 14 weeks
Darusentan Placebo
PLACEBO COMPARATORPlacebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks
Interventions
Placebo to match darusentan administered orally once daily
Eligibility Criteria
You may qualify if:
- Subjects who are competent to provide written consent;
- Aged 35 to 80 years;
- Subjects with diabetes and/or chronic kidney disease must have an average sitting systolic blood pressure greater than or equal to 130 mmHg;
- All other subjects must have an average sitting systolic blood pressure greater than or equal to 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 least 2 years or surgically sterile).
You may not qualify if:
- Average sitting systolic and diastolic blood pressure greater than or equal to 180 mmHg and 110 mmHg, respectively;
- Subjects treated with a central alpha-2 agonist and/or imidazoline receptor agonist;
- Left ventricular dysfunction;
- Serum ALT or AST greater than 2 times the Upper Limit of Normal;
- 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;
- Implanted pacemakers or cardioverter defibrillator;
- Symptomatic congestive heart failure requiring treatment;
- Hemodynamically significant valvular heart disease;
- Hemodialysis or peritoneal dialysis, or history of renal transplant;
- Type I diabetes mellitus;
- Diagnosis or recurrence of malignancy within the past 3 years;
- Sleep apnea, unless a recent sleep study demonstrated arterial oxygenation saturation greater than or equal to 90%, treated or untreated;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (147)
Alabama Internal Medicine, PC
Birmingham, Alabama, 35235, United States
Greystone Medical Research, LLC
Birmingham, Alabama, 35242, United States
The Heart Center, PC
Huntsville, Alabama, 35801, United States
Mulberry Medical Associates, PC
Montgomery, Alabama, 36106, United States
Arizona Center for Clinical Research
Glendale, Arizona, 85306, United States
Cardiovascular Consultants, Ltd.
Glendale, Arizona, 85306, United States
Lovelace Scientific Resources, Inc
Phoenix, Arizona, 85016, United States
Cochise Clinical Research
Sierra Vista, Arizona, 85635, United States
Southwest Heart
Tucson, Arizona, 85715, United States
HealthFirst Physician of AR, PA dba Convenient Care Clinic
Hot Springs, Arkansas, 71913, United States
NEA Clinic
Jonesboro, Arkansas, 72401, United States
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, 72204, United States
Medical Investigations Inc.
Little Rock, Arkansas, 72205, United States
Highgrove Medical Center
Bakersfield, California, 93301, United States
Central Cardiology Medical Clinic
Bakersfield, California, 93308, United States
Impact Clinical Trials
Beverly Hills, California, 90211, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
Rancho Cucamonga Clinical Trials
Rancho Cucamonga, California, 91730, United States
Pacific Heart Institute
Santa Monica, California, 90404, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80218, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Doctors Medical Center of Walton County
DeFuniak Springs, Florida, 32435, United States
Broward General Medical Center
Fort Lauderdale, Florida, 33316, United States
Maxine Hamilton, MD, PA
Fort Lauderdale, Florida, 33316, United States
St. John's Center for Clinical Research
Jacksonville, Florida, 32259, United States
Private Practice of Dr. Bridget Bellingar
Largo, Florida, 33773, United States
A+ Research Inc.
Miami, Florida, 33144, United States
AppleMed Research, Inc.
Miami, Florida, 33155, United States
Internal Medicine Associates of South Florida
North Miami Beach, Florida, 33179, United States
Ormond Medical Arts Pharmaceutical Research center
Ormond Beach, Florida, 32174, United States
Northwest Florida Heart Group, PA - Research Dept
Pensacola, Florida, 32514, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34231, United States
Suncoast Cardiovascular Research, Inc.
St. Petersburg, Florida, 33701, United States
Tampa Bay Nephrology Associates, PL
Tampa, Florida, 33603, United States
Orlando Rangel, MD, PA
Tampa, Florida, 33607, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
AMR Research Associates, LLC
Bogart, Georgia, 30622, United States
Atlanta Vascular Research Foundation
Tucker, Georgia, 30084, United States
North Shore Cardiologist
Bannockburn, Illinois, 60015, United States
Consultants in Cardiovascular Med (CIS)
Melrose Park, Illinois, 60160, United States
Illinois Heart & Lunch Research
Normal, Illinois, 61761, United States
Methodist Medical Center-Heart, Lung & Vascular Institute
Peoria, Illinois, 61606, United States
Medical Consultants, PC
Muncie, Indiana, 47303, United States
University Medical Associates
Louisville, Kentucky, 40202, United States
Dr. Jeffrey Chen
Lafayette, Louisiana, 70503, United States
Louisiana Research Associates, Inc
New Orleans, Louisiana, 70114, United States
Maine Research Associate
Auburn, Maine, 04210, United States
PrimeCare Internal Medicine
Biddeford, Maine, 04005, United States
Great Lakes Heart Center of Alpena
Alpena, Michigan, 49707, United States
Internal Medicine of Nothern Michigan
Petoskey, Michigan, 49770, United States
Minneapolis VAMC
Minneapolis, Minnesota, 55417, United States
Central Minnesota Heart Center at St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
St. Paul Cardiology
Saint Paul, Minnesota, 55102, United States
Glacier View Cardiology, PC
Kalispell, Montana, 59901, United States
Impact Clinical Trials
Las Vegas, Nevada, 89106, United States
NJ Heart
Linden, New Jersey, 07036, United States
New Jersey Physicians
Passaic, New Jersey, 07055, United States
Lifeline Research Institute
Brooklyn, New York, 11214, United States
Metrolina Internal Medicine, PA
Charlotte, North Carolina, 28204, United States
Heart Care Center of Charlotte
Charlotte, North Carolina, 28211, United States
Physicians East, PA
Winterville, North Carolina, 27858, United States
Plaza Medical Group, PC
Oklahoma City, Oklahoma, 73112, United States
Castlerock Clinical Research Counsultants, LLC
Tulsa, Oklahoma, 74136, United States
Integrated Medical Research PC
Ashland, Oregon, 97520, United States
Blackstone Cardiology Associates
Pawtucket, Rhode Island, 02860, United States
Charleston Cardiology
Charleston, South Carolina, 29403, United States
Paris View Family Practice
Greenville, South Carolina, 29601, United States
Internal Medicine of Greer
Greer, South Carolina, 29651, United States
Scenic City Research
Cleveland, Tennessee, 37311, United States
Southeast Texas Clinical Research Center
Beaumont, Texas, 77702, United States
Cardiovascular Research Inst. of Dallas
Dallas, Texas, 75231, United States
Galenos Research
Dallas, Texas, 75251, United States
Sergio F Rovner, MD
El Paso, Texas, 79935, United States
Salim Gopalani, MD, PA
Houston, Texas, 77008, United States
Humayun Mirza, MD, PA
Houston, Texas, 77055, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Houston Clinical Research Assoc.
Houston, Texas, 77090, United States
Innovative Research of West Florida
Hurst, Texas, 76054, United States
North Texas Medical Research
Plano, Texas, 75093, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
Fletcher Allen Health Care/University of Vermont
Burlington, Vermont, 05401, United States
Kamlesh N. Dave Cardiology
Hopewell, Virginia, 23860, United States
WVU Physicians of Charleston
Charleston, West Virginia, 25304, United States
Alpha Medical Research, LLC
Madison, Wisconsin, 43717, United States
Executive Health and Research Associates
Madison, Wisconsin, 53717, United States
Hospital Italiano Regional del Sur
Bahía Blanca, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Bahia Blanca
Bahía Blanca, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Consultorios Medicos Privados S.A.
Buenos Aires, Argentina
Hospital General de Agudos "Dr. Abel Zubizarreta"
Buenos Aires, Argentina
Policlinica Bancaria "9 de Julio"
Buenos Aires, Argentina
Diabaid (Instituto de Asistencia Integral en Diabetes)
Ciudad de Buenos Aires, Argentina
MD Investigaciones
Ciudad de Buenos Aires, Argentina
Centro Medico Privado
Ciudad de, Argentina
Instituto de Cardiologia de Corrientes
Corrientes, Argentina
Fundacion Rusculleda
Córdoba, Argentina
Framingham Centro Medico
La Plata, Argentina
Instituto de Investigaciones Clinicas de Quilmes
Quilmes, Argentina
Instituto de Investigaciones Clinicas
Rosario, Argentina
Centro de Investigaciones Clinicas del Litoral
Santa Fe, Argentina
Flinders Medical Centre
Bedford Park, Australia
Royal Brisbane & Women's Hospital
Herston, Australia
Alfred Hospital
Melbourne, Australia
Royal Perth Hospital
Perth, Australia
U.Z. Brussel
Brussels, Belgium
Private Practice of Dr. Geert Hollanders
De Pinte, Belgium
Private Practice of Dr. Francis Vrancken
Genk, Belgium
Private Practice of Dr. Herwig Van Aerde
Genk, Belgium
Private Practice of Dr. Willy Denier
Genk, Belgium
Private Practice of Dr. Herman Docx
Hoeilaart, Belgium
Private Practice of Dr. Yohan Balthazar
Natoye, Belgium
Private Practice of Dr. Sophie Baeyens
Pulle, Belgium
Private Practice of Dr. Jean Gilissen
Riemst, Belgium
Private Practice of Dr. Guido Mehuys
Tielt, Belgium
Private Practice of Dr. Luc Capiau
Wetteren, Belgium
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Brazil
Aalborg University Hospital
Aalborg, Denmark
Region Sjaelland, Storstrommens Sygenhus, Naestved
Næstved, Denmark
Private Practice of dr. Marty Jacques
Mûrs-Erigné, Murs-Erigne, France
George Delamare
Blois, France
Centre d'Investigation Clinique
Dommartin-lès-Toul, France
Private Practice of Dr. Brune Charrier
La Jubaudière, France
Private Practice of Dr. Jean Boulet-Gercourt
Le Mesnil-en-Vallée, France
Private Practice of Dr. Gildas Ganuchaud
Le Temple-de-Bretagne, France
Private Practice of Dr. Jacques Samat
Martigues, France
Private Practice of Dr. Alain Boye
Nantes, France
Private Practice of Dr. Francois Volny
Nantes, France
Private Practice of Dr. Thierry Schaupp
Vihiers, France
Private Practice of Dr. Josef Junggeburth
Bad Wörishofen, Germany
Charite Campus Mitte, Universitatsmedizin Berlin
Berlin, Germany
Klinische Forschung Berlin-Buch GmbH
Berlin, Germany
Private Practice of Dr. Isabelle Schenkenberger
Berlin, Germany
Private Practice of Dr. Tobias Marsen
Cologne, Germany
PD Dr. med. Bernhard Winkelmann
Frankfurt, Germany
Clinical Research Hamburg
Hamburg, Germany
Dr. Med. Susanne Mindt-Prufert
Hamburg, Germany
Private Practice for Internal Medicine & Cardiology
Heidelberg, Germany
IFG-Institut fur Gesundheitsforderung GmbH
Rüdersdorf, Germany
Centre for Clinical Research and Effective Practice (CCRep)
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Greenlane Clinical Centre
Greenlane, New Zealand
Cardiology Clinical Trial Unit
Hamilton, New Zealand
Tauranga Hospital
Tauranga, New Zealand
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital General Universitario de Elche
Elche, Spain
Related Publications (1)
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.
PMID: 20921430DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2006
First Posted
October 19, 2006
Study Start
September 1, 2006
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
March 18, 2014
Record last verified: 2014-02