DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension

This study has been terminated.

(Study DAR-312 did not meet primary co-endpoints)

Sponsor:

Information provided by:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT00353574

First received: July 17, 2006

Last updated: March 23, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 17, 2006
Last Updated Date	March 23, 2011
Start Date ^ICMJE	September 2006
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 12, 2008)	The primary safety measures are based on general safety assessments including additional emphasis on predefined clinical assessments. [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ] The primary efficacy measures are change in trough sitting systolic and diastolic blood pressures. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: July 17, 2006)	The primary efficacy measure is change from baseline in trough sitting systolic blood pressure, and the primary safety measure is based on general safety assessments including additional emphasis on predefined clinical assessments.
Change History	Complete list of historical versions of study NCT00353574 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 12, 2008)	Secondary efficacy measurements include: change in mean 24-hour systolic and diastolic ambulatory blood pressures. [ Time Frame: Week 14 ] [ Designated as safety issue: No ] Percent of subjects who reach systolic blood pressure goal [ Time Frame: Week 14 ] [ Designated as safety issue: No ] Change in estimated glomerular filtration rate (eGFR) [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: July 17, 2006)	Secondary efficacy measurements include: change from baseline in trough sitting diastolic blood pressure measured by sphygmomanometry mean 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring percent of subjects who reach systolic blood pressure goal estimated glomerular filtration rate (eGFR)
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
Official Title ^ICMJE	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)
Brief Summary	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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	Drug: darusentan 3 tablets QD, PO
Study Arm (s)	Experimental: 1 50 mg Intervention: Drug: darusentan Experimental: 2 100 mg Intervention: Drug: darusentan Experimental: 3 300 mg Intervention: Drug: darusentan
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	282
Completion Date	April 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	35 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Brazil, Canada, Denmark, France, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00353574
Other Study ID Numbers ^ICMJE	DAR-311-E
Has Data Monitoring Committee	Yes
Responsible Party	Luiz Belardinelli, Senior Vice President, Clinical Research, Gilead Sciences, Inc.
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Gilead Sciences
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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