An Eight-Week Study to Evaluate the Efficacy and Safety o... | NCT00332891

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

NCT00332891

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 9, 2009Estimated

Enrollment

508Actual

Phase

Phase 3

Conditions

Anxiety Disorders

Interventions

SR58611A

Countries

Bulgaria
Croatia
Czechia
Poland
Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Jun 1, 2006

First Submission Date that Met QC Criteria

Jun 1, 2006

First Posted Date

Jun 2, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2009

Last Update Posted Date

Mar 9, 2009Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

508Actual

Name	Type	Description	Arm Group Labels	Other Names
SR58611A	Drug

Outcomes Module

Primary Outcomes

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.

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Sofia			Bulgaria
Sanofi-Aventis Administrative Office