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| Sponsored by: |
Sanofi-Aventis |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00439634 |
Purpose
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 MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) in schizophrenic patients.
The secondary objectives are to measure the efficacy of AVE1625 on functional capacity of the patients using a specific scale called UPSA2 (University of California San Diego Performance-based Skills Assessment 2) and to assess the safety of the compound.
| Condition | Intervention | Phase |
|
Schizophrenia |
Drug: AVE1625 |
Phase II |
| MedlinePlus related topics: | Schizophrenia |
| ChemIDplus related topics: | Risperidone Quetiapine Quetiapine fumarate Olanzapine Aripiprazole Paliperidone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A 24-Week, Double-Blind, Randomized, Parallel-Group, Study of the Efficacy and Safety of 3 Oral Doses of AVE1625 on Top of Either Olanzapine, Risperidone/Paliperidone, Quetiapine or Aripiprazole in the Treatment of Cognitive Impairment in Schizophrenia |
| Estimated Enrollment: | 700 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The investigator will evaluate whether there are other reasons why a patient may not participate.
Contacts and Locations| Contact: Public Registry ICD | GV-Contact-us@sanofi-aventis.com |
| United States, Pennsylvania | |||||
| Sanofi-Aventis | Recruiting | ||||
| Malvern, Pennsylvania, United States, 19355 | |||||
| Contact GV-Contact-us@sanofi-aventis.com | |||||
| Canada | |||||
| Sanofi-Aventis Administrative Office | Recruiting | ||||
| Laval, Canada | |||||
| Contact GV-Contact-us@sanofi-aventis.com | |||||
| Sanofi-Aventis |
| Study Director: | ICD CSD | Sanofi-Aventis |
More Information
Related Info 
  |
| Responsible Party: | Sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | DRI6726, AVE1625 |
| First Received: | February 22, 2007 |
| Last Updated: | June 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00439634 |
| Health Authority: | United States: Food and Drug Administration |
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