drugset / Trial / NCT00353574

DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension

NCT00353574

Phase 3 Terminated 282 enrolled Gilead Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.

Timeline

Start
2006-09
Primary completion
2010-02
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Darusentan Other / unclassified 50 mg Oral
Subject Darusentan Other / unclassified 100 mg Oral
Subject Darusentan Other / unclassified 300 mg Oral

Indications