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The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A.
The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR58611A | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score. |
| Measure | Description | Time Frame |
|---|---|---|
| The main secondary outcomes are the changes from baseline to Day 56 of treatment in the CGI Severity of Illness Score, percentage of patients with HAM-A treatment response and change from baseline in the HAM-A somatic and psychic anxiety factor scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Buenos Aires | Argentina | ||||
| Sanofi-Aventis Administrative Office |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000722902 | Amibegron hydrochloride |
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| Vienna |
| Austria |
| Sanofi-Aventis Administrative Office | Tallinn | Estonia |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Midrand | South Africa |
| Sanofi-Aventis Administrative Office | Bromma | Sweden |