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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00390533 |
The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.
Condition | Intervention | Phase |
---|---|---|
Generalized Anxiety |
Drug: Saredutant |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | An Eight-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, to Evaluate the Efficacy, Safety and Tolerability of Two Fixed Doses (100 and 30 mg Once Daily) of Saredutant in Patients With Generalized Anxiety Disorder |
Estimated Enrollment: | 405 |
Study Start Date: | October 2006 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
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.
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Australia | |
Sanofi-Aventis Administrative Office | |
Macquarie Park, Australia |
Study Director: | Marie TRAD, MD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC5582, SR48968 |
Study First Received: | October 19, 2006 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00390533 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration |
Anxiety clinical trials |
Anxiety Disorders Mental Disorders |
Anxiety Disorders Mental Disorders |