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

NCT00332891 | Completed Phase 3

• 1 other identifier: EFC5891
• Study Type: interventional
• Target: 508
• Locations: 5 countries
• Sites: 5

Brief Summary

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 350 mg and 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

Conditions

Anxiety Disorders

Keywords

Anxiety; Anti-Anxiety Agents; controlled Clinical Trials

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Interventions

SR58611A DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from generalized anxiety disorder (GAD) as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module
• Total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) equal or above 20.

You may not qualify if:

• Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within 6 months of study entry.
• Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher at screening or baseline visits.
• Patients having a moderate to high current risk for suicide.
• Patients with other current anxiety disorder assessed with the MINI: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder.
• Patients with a lifetime history according to the MINI of: bipolar disorders, psychotic disorders, antisocial personality disorder.
• Patients with severe or unstable concomitant medical conditions according to the Investigator's judgment.
• Females who are pregnant or lactating.
• Female patients of childbearing potential must use an effective method of birth control during the entire study period.
• Patients with positive test for any illicit drug included in the urine drug screen.
• Participation in a clinical trial of an experimental therapy within 3 months prior to screening

Sponsors & Collaborators

• Sanofi: lead

Study Sites (5)

Sanofi-Aventis Administrative Office

Sofia, Bulgaria

Location

Sanofi-Aventis Administrative Office

Zagreb, Croatia

Location

Sanofi-Aventis Administrative Office

Prague, Czechia

Location

Sanofi-Aventis Administrative Office

Warsaw, Poland

Location

Sanofi-Aventis Administrative Office

Belgrade, Serbia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Amibegron hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 1, 2006
• First Posted: June 2, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: March 9, 2009

Record last verified: 2009-03

Locations

PL (1); BU (1); CZ (1); SE (1); CR (1)