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: “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.

Intervention(s) in this Clinical Trial

• Drug: darusentan (LU 135252) and guanfacine
  • 1 capsule QD, PO

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 50, 100, or 300 mg
• Active Comparator: 2
  • 1 mg

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Gilead Sciences Industry

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00389675

Study ID Number: Protocol DAR-312-E

ClinicalTrials.gov Identifier: NCT00389675

Health Authority: United States: Food and Drug Administration