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 (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00389675
First received: October 17, 2006
Last updated: January 3, 2014
Last verified: January 2014

October 17, 2006
January 3, 2014
May 2007
February 2010   (final data collection date for primary outcome measure)
  • Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
  • Percentage of subjects who reach systolic blood pressure goal [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
Long-term darusentan safety in subjects with resistant systolic hypertension despite treatment with full doses of 3 or more antihypertensive medications, including a diuretic
Complete list of historical versions of study NCT00389675 on ClinicalTrials.gov Archive Site
Change from baseline in trough sitting systolic and diastolic blood pressures [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
661
May 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil
 
NCT00389675
Protocol DAR-312-E
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
January 2014

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