DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension

This study has been terminated.

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

Sponsor:

Information provided by:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT00389675

First received: October 17, 2006

Last updated: March 23, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 17, 2006
Last Updated Date	March 23, 2011
Start Date ^ICMJE	May 2007
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 12, 2008)	Primary efficacy measures include (i) change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressures, (ii) percent of subjects who reach systolic blood pressure goal, and (iii) change from baseline in eGFR [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: October 18, 2006)	Long-term darusentan safety in subjects with resistant systolic hypertension despite treatment with full doses of 3 or more antihypertensive medications, including a diuretic
Change History	Complete list of historical versions of study NCT00389675 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 12, 2008)	Secondary efficacy measures are change from baseline in trough sitting systolic and diastolic blood pressures, and the primary safety measures are based on general safety assessments including additional emphasis on predefined clinical assessments [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 18, 2006)	Long-term darusentan efficacy measured as change from baseline 1) in trough sitting SBP and DBP by sphygmomanometry; 2) in mean 24-hour SBP and DBP by ABPM; 3) percent of subjects reaching systolic blood pressure goal; 4) in eGFR.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
Official Title ^ICMJE	A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects With Resistant Hypertension Despite Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)
Brief Summary	This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in 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 evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.
Detailed Description	Not Provided
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 (LU 135252) and guanfacine 1 capsule QD, PO Other Name: guanfacine
Study Arm (s)	Experimental: 1 50, 100, or 300 mg Intervention: Drug: darusentan (LU 135252) and guanfacine Active Comparator: 2 1 mg Intervention: Drug: darusentan (LU 135252) and guanfacine
Publications *	Not Provided
* 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	661
Completion Date	May 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	SELECTED INCLUSION CRITERIA: Subjects must be competent to provide written informed consent; Subjects must have completed the Maintenance Period of the DAR-312 study. SELECTED EXCLUSION CRITERIA: Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 due to a study drug-related AE; Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.
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, Australia, Brazil

Administrative Information
NCT Number ^ICMJE	NCT00389675
Other Study ID Numbers ^ICMJE	Protocol DAR-312-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	Not Provided
Investigators ^ICMJE	Not Provided
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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