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
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
| 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 |
| Comparator | Guanfacine | Small molecule | 1 mg | Oral |