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NCT00389779 Clinical Trial

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

Hypertension Clinical Trial

— Darusentan  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00389779
Other study ID # Protocol DAR-312
Secondary ID
Status Completed
Phase Phase 3
First received October 17, 2006
Last updated February 19, 2014
Start date September 2006
Est. completion date August 2009

Study information
Verified date February 2014
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 849
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 80 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Darusentan
Darusentan capsules administered orally once daily
• Guanfacine
Guanfacine capsules administered orally once daily
• Darusentan Placebo
Placebo to match darusentan administered orally once daily

Locations
Country Name City State
Argentina Hospital Italiano Regional del Sur Bahia Blanca Buenos Aires
Argentina Instituto de Investigaciones Clinicas Bahia Blanca Bahia Blanca 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 Centro Medico Privado Ciudad de
Argentina Diabaid (Instituto de Asistencia Integral en Diabetes) Ciudad de Buenos Aires
Argentina MD Investigaciones Ciudad de Buenos Aires
Argentina Fundacion Rusculleda Cordoba
Argentina Instituto de Cardiologia de Corrientes Corrientes
Argentina Framingham Centro Medico La Plata
Argentina Instituto de Investigaciones Clinicas Mar del Plata Mar del Plata Buenos Aires
Argentina Instituto de Investigaciones Clinicas de Quilmes Quilmes
Argentina Instituto de Investigaciones Clinicas Rosario
Argentina Centro de Investigaciones Clinicas del Litoral Santa Fe
Australia Flinders Medical Centre Bedford Park
Australia Royal Brisbane & Women's Hospital Herston
Australia Alfred Hospital Melbourne
Australia Royal Perth Hospital Perth
Belgium U.Z. Brussel Brussel
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
Brazil Hospital Universitario Pedro Ernesto Rio de Janeiro
Denmark Aalborg University Hospital Aalborg
Denmark Region Sjaelland, Storstrommens Sygenhus, Naestved Naestved
France George Delamare Blois
France Centre d'Investigation Clinique Dommartin les Toul
France Private Practice of Dr. Brune Charrier La Jubaudiere
France Private Practice of Dr. Jean Boulet-Gercourt Le Mesnil en vallee
France Private Practice of Dr. Gildas Ganuchaud Le Temple-de-Bretagne
France Private Practice of Dr. Jacques Samat Martigues
France Private Practice of dr. Marty Jacques Murs-Erigne
France Private Practice of Dr. Alain Boye Nantes
France Private Practice of Dr. Francois Volny Nantes
France Private Practice of Dr. Thierry Schaupp Vihiers
Germany Private Practice of Dr. Josef Junggeburth Bad Worishofen
Germany Charite Campus Mitte, Universitatsmedizin Berlin Berlin
Germany Klinische Forschung Berlin-Buch GmbH Berlin
Germany Private Practice of Dr. Isabelle Schenkenberger Berlin
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 Private Practice of Dr. Tobias Marsen Koeln
Germany IFG-Institut fur Gesundheitsforderung GmbH Ruedersdorf
New Zealand 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
Spain Hospital Universitario de Bellvitge Barcelona
Spain Hospital General Universitario de Elche Elche
United States Great Lakes Heart Center of Alpena Alpena Michigan
United States Integrated Medical Research PC Ashland Oregon
United States Maine Research Associate Auburn Maine
United States Medical College of Georgia Augusta Georgia
United States Aurora Denver Cardiology Associates Aurora Colorado
United States Aurora Denver Cardiology Associates Aurora Colorado
United States Central Cardiology Medical Clinic Bakersfield California
United States Highgrove Medical Center Bakersfield California
United States North Shore Cardiologist Bannockburn Illinois
United States Southeast Texas Clinical Research Center Beaumont Texas
United States Impact Clinical Trials Beverly Hills California
United States PrimeCare Internal Medicine Biddeford Maine
United States Alabama Internal Medicine, PC Birmingham Alabama
United States Greystone Medical Research, LLC Birmingham Alabama
United States AMR Research Associates, LLC Bogart Georgia
United States Lifeline Research Institute Brooklyn New York
United States Fletcher Allen Health Care/University of Vermont Burlington Vermont
United States Charleston Cardiology Charleston South Carolina
United States WVU Physicians of Charleston Charleston West Virginia
United States Heart Care Center of Charlotte Charlotte North Carolina
United States Metrolina Internal Medicine, PA Charlotte North Carolina
United States Scenic City Research Cleveland Tennessee
United States Clinical Research of South Florida Coral Gables Florida
United States Cardiovascular Research Inst. of Dallas Dallas Texas
United States Galenos Research Dallas Texas
United States Doctors Medical Center of Walton County Defuniak Springs Florida
United States Sergio F Rovner, MD El Paso Texas
United States Broward General Medical Center Fort Lauderdale Florida
United States Maxine Hamilton, MD, PA Ft. Lauderdale Florida
United States Arizona Center for Clinical Research Glendale Arizona
United States Cardiovascular Consultants, Ltd. Glendale Arizona
United States Paris View Family Practice Greenville South Carolina
United States Internal Medicine of Greer Greer South Carolina
United States Kamlesh N. Dave Cardiology Hopewell Virginia
United States HealthFirst Physician of AR, PA dba Convenient Care Clinic Hot Springs Arkansas
United States Clinical Trial Network Houston Texas
United States Houston Clinical Research Assoc. Houston Texas
United States Humayun Mirza, MD, PA Houston Texas
United States Salim Gopalani, MD, PA Houston Texas
United States The Heart Center, PC Huntsville Alabama
United States Innovative Research of West Florida Hurst Texas
United States St. John's Center for Clinical Research Jacksonville Florida
United States NEA Clinic Jonesboro Arkansas
United States Glacier View Cardiology, PC Kalispell Montana
United States Dr. Jeffrey Chen Lafayette Louisiana
United States Private Practice of Dr. Bridget Bellingar Largo Florida
United States Impact Clinical Trials Las Vegas Nevada
United States NJ Heart Linden New Jersey
United States Arkansas Primary Care Clinic, PA Little Rock Arkansas
United States Medical Investigations Inc. Little Rock Arkansas
United States VA Greater Los Angeles Healthcare System Los Angeles California
United States University Medical Associates Louisville Kentucky
United States Alpha Medical Research, LLC Madison Wisconsin
United States Executive Health and Research Associates Madison Wisconsin
United States Consultants in Cardiovascular Med (CIS) Melrose Park Illinois
United States A+ Research Inc. Miami Florida
United States AppleMed Research, Inc. Miami Florida
United States Minneapolis VAMC Minneapolis Minnesota
United States Mulberry Medical Associates, PC Montgomery Alabama
United States Medical Consultants, PC Muncie Indiana
United States Internal Medicine Associates of South Florida N. Miami Beach Florida
United States Louisiana Research Associates, Inc New Orleans Louisiana
United States Illinois Heart & Lunch Research Normal Illinois
United States Plaza Medical Group, PC Oklahoma City Oklahoma
United States Ormond Medical Arts Pharmaceutical Research center Ormond Beach Florida
United States New Jersey Physicians Passaic New Jersey
United States Blackstone Cardiology Associates Pawtucket Rhode Island
United States Northwest Florida Heart Group, PA - Research Dept Pensacola Florida
United States Methodist Medical Center-Heart, Lung & Vascular Institute Peoria Illinois
United States Internal Medicine of Nothern Michigan Petoskey Michigan
United States Lovelace Scientific Resources, Inc Phoenix Arizona
United States North Texas Medical Research Plano Texas
United States Rancho Cucamonga Clinical Trials Rancho Cucamonga California
United States Pacific Heart Institute Santa Monica California
United States Cardiovascular Center of Sarasota Sarasota Florida
United States Cochise Clinical Research Sierra Vista Arizona
United States Central Minnesota Heart Center at St. Cloud Hospital St. Cloud Minnesota
United States St. Paul Cardiology St. Paul Minnesota
United States Suncoast Cardiovascular Research, Inc. St. Petersburg Florida
United States Orlando Rangel, MD, PA Tampa Florida
United States Tampa Bay Nephrology Associates, PL Tampa Florida
United States Scott & White Memorial Hospital Temple Texas
United States Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Torrance California
United States Atlanta Vascular Research Foundation Tucker Georgia
United States Southwest Heart Tucson Arizona
United States Castlerock Clinical Research Counsultants, LLC Tulsa Oklahoma
United States Physicians East, PA Winterville North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Denmark,  France,  Germany,  New Zealand,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry Baseline to Week 14 No
Secondary Percentage of subjects reaching systolic blood pressure goal after 14 weeks of treatment Week 14 No
Secondary Change from baseline in mean 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) Baseline to Week 14 No
Secondary Change from baseline in estimated glomerular filtration rate (eGFR) Baseline to Week 14 No
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