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NCT00439634 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of AVE1625 as a Co-treatment With Antipsychotic Therapy in Schizophrenia
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 873
- Enrollment target
NCT00439634: Clinical Trial Phase 2 study, sponsored by Sanofi.
NCT00439634 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 873 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (556% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00439634, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 873 participants
- Enrollment target
Study Summary
AVE1625 is a new potent and selective cannabinoid 1 (CB1) antagonist in clinical development for the treatment of cognitive impairment in patients diagnosed with schizophrenia. The main objective of this study is to evaluate the efficacy on cognitive impairment of 3 doses of AVE1625 using a new cognitive battery called Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) in schizophrenic patients. The secondary objectives are to measure the efficacy of AVE1625 on functional capacity of the patients using a specific scale called University of California San Diego Performance-based Skills Assessment 2 (UPSA2) and to assess the safety of the compound.
Interventions
- DRUG placebo
- DRUG AVE1625
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 873 participants |
| Start Date | 2007-02 |
| Est. Completion | 2009-09 |
| Phase | Phase 2 |
Why NCT00439634 stopped before completion
NCT00439634 is an interventional study that assigns participants to a tested intervention. The registered 873 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (556% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00439634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00439634 about?
NCT00439634 is a clinical study titled "Efficacy and Safety of AVE1625 as a Co-treatment With Antipsychotic Therapy in Schizophrenia". AVE1625 is a new potent and selective cannabinoid 1 (CB1) antagonist in clinical development for the treatment of cognitive impairment in patients diagnosed with schizophrenia. The main objective of this study is to evaluate the efficacy on cognitive impairment of 3 doses of AVE1625 using a new cog...
What is the current status of trial NCT00439634?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 873 participants. The study started on 2007-02. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00439634?
The interventions under investigation include: placebo (DRUG), AVE1625 (DRUG).
Who is sponsoring clinical trial NCT00439634?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00439634's enrollment target sits among peer trials
873 33rd of 2000 higher than 1,968 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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