drugset / Trial / NCT00353574
DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darusentan | Other / unclassified | 50 mg | Oral |
| Subject | Darusentan | Other / unclassified | 100 mg | Oral |
| Subject | Darusentan | Other / unclassified | 300 mg | Oral |