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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 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 873 participants.

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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

FieldValue
Enrollment Target 873 participants
Start Date 2007-02
Est. Completion 2009-09
Phase Phase 2

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00439634

The ClinicalTrials.gov registry entry for NCT00439634 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 873 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00439634 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.