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

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ClinicalTrials.gov Identifier: NCT00389675
Recruitment Status : Terminated (Study DAR-312 did not meet its primary co-endpoints.)
First Posted : October 19, 2006
Last Update Posted : January 6, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE October 17, 2006
First Posted Date  ICMJE October 19, 2006
Last Update Posted Date January 6, 2014
Study Start Date  ICMJE May 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2014)
  • Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure [ Time Frame: Baseline to Week 14 ]
  • Percentage of subjects who reach systolic blood pressure goal [ Time Frame: Week 14 ]
  • Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Week 14 ]
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
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2014)
Change from baseline in trough sitting systolic and diastolic blood pressures [ Time Frame: Baseline to Week 14 ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Darusentan
    Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
    Other Name: LU 135252
  • Drug: Guanfacine
    Guanfacine 1 mg capsules administered orally once daily
Study Arms  ICMJE
  • Experimental: Darusentan
    Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily
    Intervention: Drug: Darusentan
  • Active Comparator: Guanfacine
    Guanfacine 1 mg capsules administered orally once daily
    Intervention: Drug: 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
Actual Enrollment  ICMJE
 (submitted: October 2, 2009)
661
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

SELECTED INCLUSION CRITERIA:

  1. Subjects must be competent to provide written informed consent;
  2. Subjects must have completed the Maintenance Period of the DAR-312 study.

SELECTED EXCLUSION CRITERIA:

  1. 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;
  2. Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389675
Other Study ID Numbers  ICMJE Protocol DAR-312-E
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gilead Sciences
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP