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NCT00389675 · ClinicalTrials.gov registry record · Phase 3
DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 661
- Enrollment target
NCT00389675: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT00389675 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 661 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00389675, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 661 participants
- Enrollment target
Study 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.
Interventions
- DRUG Guanfacine
- DRUG Darusentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 661 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
Why NCT00389675 stopped before completion
NCT00389675 is an interventional study that assigns participants to a tested intervention. The registered 661 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Guanfacine is the first listed.
NCT00389675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00389675 about?
NCT00389675 is a clinical study titled "DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension". 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 lo...
What is the current status of trial NCT00389675?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 661 participants. The study started on 2007-05. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00389675?
The interventions under investigation include: Guanfacine (DRUG), Darusentan (DRUG).
Who is sponsoring clinical trial NCT00389675?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00389675's enrollment target sits among peer trials
661 556th of 2000 higher than 1,445 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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