Hypertension Clinical Trial
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)
| 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 |
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.
| Status | Completed |
| Enrollment | 352 |
| Est. completion date | January 2009 |
| Est. primary completion date | January 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | CIMEL | Buenos Aires | |
| Argentina | DIM (Clinica Privada) | Buenos Aires | |
| Argentina | Fundapres | Buenos Aires | |
| Argentina | Hospital Britanico 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 | Buenos Aires | |
| Argentina | Clinica Chutro SRL | Cordoba | |
| Argentina | Hospital San Roque | Cordoba | |
| 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 | Instituto de Molestias | São José do Rio Preto | |
| Brazil | Centro integrado hospital | Sao Paulo | |
| Brazil | Centro Integrado Hospital do Rim e Hipertensao | Sao Paulo | |
| Brazil | Hospital das Clinicas da Faculdade de Medicina da USP | Sao Paulo | |
| Canada | Cambridge Cardiac Care Center | Cambridge | Ontario |
| Canada | Clinical Research Solutions | Kitchener | Ontario |
| Denmark | Hvidovre Hospital | Hvidovre | |
| Denmark | Bispebjerg Hospital | København | |
| 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 | |
| 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 | |
| Italy | Azienda Ospedaliera University of Padua Policlinico | Padua | |
| Spain | Fundacio Puigvert | Barcelona | |
| Spain | Hospital Clinic i Provincial | Barcelona | |
| Spain | Hospital del Mar | 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 | |
| Sweden | Cardiovascular Research, Karolinska Institue | Stockholm | |
| United Kingdom | Stonehill Medical Centre | Bolton, | |
| United Kingdom | Townhead Surgery | Scotland | |
| United Kingdom | Avenue Surgery | Wiltshire | |
| United Kingdom | Hathaway Medical Centre | Wiltshire | |
| United States | Northeast Clinical Research Centers, Inc. | Allentown | Pennsylvania |
| United States | Maine Research Associates | Auburn | Maine |
| United States | MODEL Clinical Research | Baltimore | Maryland |
| United States | Professional Clinical Research | Benzonia | Michigan |
| United States | UAB Hypertension Program | Birmingham | Alabama |
| United States | Connecticut Clinical Research, LLC | Bridgeport | Connecticut |
| United States | Bronx VA Medical Center / Mt. Sinai | Bronx | New York |
| United States | Burke Internal Medicine, Inc. | Burke | Virginia |
| United States | Global Research Partners | Calhoun | Georgia |
| United States | Heritage Cardiology Associates | Camp Hill | Pennsylvania |
| United States | CAMC Clinical Trials Center | Charleston | West Virginia |
| United States | The Lindner Clinical Trial Center | Cincinnati | Ohio |
| United States | Neem Research Group, Inc. | Columbia | South Carolina |
| United States | Deerfield Beach Cardiology Associates | Deerfield Beach | Florida |
| United States | Complete Renal Care | Denver | Colorado |
| United States | Internal Medicine & Industrial Medicine | Desoto | Texas |
| United States | Brandywine Clinical Research | Downingtown | Pennsylvania |
| United States | Chicago Heart & Vein Clinic | Elk Grove Village | Illinois |
| United States | Evanston Northwestern Healthcare | Evanston | Illinois |
| United States | West Coast Cardiology Associates | Fairview Park | Ohio |
| United States | Nephrology and Hypertension / Hurley Medical Center | Flint | Michigan |
| United States | White-Wilson Medical Center | Fort Walton Beach | Florida |
| United States | T&R Clinical, P.A. | Ft Worth | Texas |
| United States | AMK Research | Gainsville | Florida |
| United States | Peninsula Inernal Medicine | Gig Harbor | Washington |
| United States | Physicians East, PA | Greenville | North Carolina |
| United States | Clinical Investigation Specialists, Inc. | Gurnee | Illinois |
| United States | A.G.A. Clinical Trials | Hialeah | Florida |
| United States | Hillsboro Cardiology, PC | Hillsboro | Oregon |
| United States | Kula Research | Honolulu | Hawaii |
| United States | Chrishard Medical Group | Inglewood | California |
| United States | Professional Clinical Research | Interlochen | Michigan |
| United States | Jacksonville Center for Clinical | Jacksonville | Florida |
| United States | Ricardo A. Bedoya, Cardiology | Jupiter | Florida |
| United States | Green and Seidner Family Practice Associates | Lansdale | Pennsylvania |
| United States | Pri-Med Care | Lewisville | Texas |
| United States | Midwest Heart Foundation | Lombard | Illinois |
| United States | VA Medical Center - WLA | Los Angeles | California |
| United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
| United States | Manassas Clinical Research Center | Manassas | Virginia |
| United States | American Clinical Research LLC | Marrero | Louisiana |
| United States | International Research Association | Miami | Florida |
| United States | Diabetes Center of the Southwest | Midland | Texas |
| United States | Comprehensive Heart Failure Center | Mobile | Alabama |
| United States | COR Clinical Research | Oklahoma City | Oklahoma |
| United States | Sooner Clinical Research | Oklahoma City | Oklahoma |
| United States | Southwest Cardiology Associates | Oklahoma City | Oklahoma |
| United States | Maryland Medical Research/Og Medical Center | Oxon Hill | Maryland |
| United States | Specialty Medical Center | Pahrump | Nevada |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | The Bracane Company | Plano | Texas |
| United States | RI Hospital | Providence | Rhode Island |
| United States | Clinical Associates | Reisterstown | Maryland |
| United States | McGuire VA Medical Center | Richmond | Virginia |
| United States | Rockville Internal Medicine Group | Rockville | Maryland |
| United States | Sacramento Heart and Vascular | Sacramento | California |
| United States | Innovative Clinical Trials | San Antonio | Texas |
| United States | Apex Research Institute | Santa Ana | California |
| United States | Cardiovascular Center of Sarasota | Sarasota | Florida |
| United States | Cardiovascular Consultants of Maine | Scarborough | Maine |
| United States | Medical Research Institute | Slidell | Louisiana |
| United States | Liberty Research Center | Tacoma | Washington |
| United States | Tampa Bay Nephrology | Tampa | Florida |
| United States | Canyon Clinical Research | Tucson | Arizona |
| United States | Castlerock Clinical Research Consultants | Tulsa | Oklahoma |
| United States | MedStar Diabetes Institute at Washington Hospital Center | Washington | District of Columbia |
| United States | Metabolic Research Institute, Inc. | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, Argentina, Brazil, Canada, Denmark, France, Germany, Italy, Spain, Sweden, United Kingdom,
| 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 | Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure | Baseline to Week 14 | No | |
| Secondary | Percentage of subjects to reach systolic blood pressure goal | Week 14 | No | |
| Secondary | Change from baseline in estimated glomerular filtration rate (eGFR) | Baseline to Week 14 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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