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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00385307
The ClinicalTrials.gov registry entry for NCT00385307 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 680 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (82% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.