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NCT00825019 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine
A Phase 3 study of Major Depressive Disorders, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 306
- Enrollment target
- 1
- Study location
NCT00825019: Completed Phase 3 study of Major Depressive Disorders, sponsored by Sanofi.
NCT00825019 is a Phase 3 study of Major Depressive Disorders that has completed, run by Sanofi. The registered enrollment target is 306 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00825019, a Phase 3 study of Major Depressive Disorders, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 306 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD). Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.
Conditions Studied
Interventions
- DRUG placebo
- DRUG paroxetine
- DRUG amibegron (SR58611A)
Study Locations (1)
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2003-09 |
| Est. Completion | 2004-12 |
| Phase | Phase 3 |
What the finished NCT00825019 record still lists
NCT00825019 is an interventional study that assigns participants to a tested intervention. The registered 306 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 (60% lower).
The record links to 1 condition, with Major Depressive Disorders appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT00825019 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT00825019 about?
NCT00825019 is a clinical study titled "Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine". Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD). Secondary objective is to assess the safety profile of ...
What is the current status of trial NCT00825019?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 306 participants. The study started on 2003-09. Estimated completion is 2004-12.
What conditions does trial NCT00825019 study?
This clinical trial studies the following conditions: Major Depressive Disorders.
What interventions are being tested in trial NCT00825019?
The interventions under investigation include: placebo (DRUG), paroxetine (DRUG), amibegron (SR58611A) (DRUG).
Who is sponsoring clinical trial NCT00825019?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00825019 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
How this trial's enrollment target compares
Where NCT00825019's enrollment target sits among peer trials
306 1115th of 2000 higher than 884 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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