Hypertension Clinical Trial
— DarusentanOfficial title:
DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study 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-E)
| 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 United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.
| Status | Terminated |
| Enrollment | 282 |
| Est. completion date | April 2010 |
| Est. primary completion date | February 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Subjects who have completed the Treatment Period of clinical trial DAR-311 - Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic Exclusion Criteria: - Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related adverse event (AE) - Treatment with another endothelin receptor antagonist within 6 months of study entry |
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 | Buenos Aires | |
| Brazil | Centro Integrado Hospital | Sao Paulo | |
| Brazil | Centro Integrado Hospital do Rim e Hipertensao | 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 | Hôpital Civil, Service HTA maladies vasculaires | Strasbourg Cedex | |
| Sweden | Cardiovascular Research, Karolinska Institue | Stockholm | |
| Sweden | University Hospital Umea | Umea | |
| 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 | Androscoggin Cardiology Associates | Auburn | Maine |
| United States | Maine Research Associate | Auburn | Maine |
| United States | Professional Clinical Research | Benzonia | Michigan |
| United States | Connecticut Clinical Research, LLC | Bridgeport | Connecticut |
| 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 | The Lindner Clinical Trial Center | Cincinnati | Ohio |
| United States | Neem Research Group, Inc. | Columbia | South Carolina |
| 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 | 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 | 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 | Manassas Clinical Research Center | Manassas | Virginia |
| United States | International Research Association | Miami | Florida |
| United States | Comprehensive Heart Failure Center | Mobile | Alabama |
| United States | COR Clinical Research | Oklahoma City | Oklahoma |
| United States | Southwest Cardiology Associates | Oklahoma City | Oklahoma |
| United States | Specialty Medical Center | Pahrump | Nevada |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | RI Hospital | Providence | Rhode Island |
| United States | Clinical Associates | Reisterstown | Maryland |
| 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 Associates, PL | 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, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in trough sitting systolic and diastolic blood pressure | Baseline to Week 14 | No | |
| Secondary | Change in mean 24-hour systolic and diastolic ambulatory blood pressures. | Baseline to Week 14 | No | |
| Secondary | Percentage of subjects who reach systolic blood pressure goal | Week 14 | No | |
| Secondary | Change in estimated glomerular filtration rate (eGFR) | Baseline to Week 14 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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