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NCT00385307 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
A Phase 3 study of Major Depressive Disorder, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 680
- Enrollment target
- 1
- Study location
NCT00385307: Completed Phase 3 study of Major Depressive Disorder, sponsored by Sanofi.
NCT00385307 is a Phase 3 study of Major Depressive Disorder that has completed, run by Sanofi. The registered enrollment target is 680 participants, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (82% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00385307, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 680 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.
Conditions Studied
Interventions
- DRUG amibegron (SR58611A)
Study Locations (1)
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 680 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-11 |
| Phase | Phase 3 |
What the finished NCT00385307 record still lists
NCT00385307 is an interventional study that assigns participants to a tested intervention. The registered 680 participants enrollment target is mid-sized for trials with a published cap, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (82% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which amibegron (SR58611A) is the first listed.
NCT00385307 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT00385307 about?
NCT00385307 is a clinical study titled "Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)". To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.
What is the current status of trial NCT00385307?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 680 participants. The study started on 2006-09. Estimated completion is 2007-11.
What conditions does trial NCT00385307 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT00385307?
The interventions under investigation include: amibegron (SR58611A) (DRUG).
Who is sponsoring clinical trial NCT00385307?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00385307 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00385307's enrollment target sits among peer trials
680 19th of 282 higher than 264 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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.
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