drugset / Trial / NCT00397098

Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder

NCT00397098

Phase 3 Terminated 257 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID) compared to placebo in the prevention of relapse of anxiety, in patients with Generalized Anxiety Disorder improved after 12 weeks of treatment with SR58611A. The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo over a 24 to 52-week treatment period. The secondary objective is to assess the safety and tolerability of SR58611A in patients with GAD.

Timeline

Start
2006-11
Primary completion
2007-09
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Subject amibegron Small molecule 350 mg

Indications