drugset / Trial / NCT00389675

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

NCT00389675

Phase 3 Terminated 661 enrolled Gilead Sciences
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-05
Primary completion
2010-02
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Darusentan Other / unclassified 50 mg Oral
Subject Darusentan Other / unclassified 100 mg Oral
Subject Darusentan Other / unclassified 300 mg Oral
Comparator Guanfacine Small molecule 1 mg Oral

Indications