drugset / Trial / NCT00535340

An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Generalized Anxiety Disorder

NCT00535340

Phase 3 Terminated 55 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A). Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility and quality of life in elderly patients with GAD and to evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.

Timeline

Start
2007-03
Primary completion
2007-08
Completion
2007-08

Drugs

EvaluationDrugModalityDoseRoute
Subject amibegron Small molecule 350 mg

Indications