Status:

COMPLETED

Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

Lead Sponsor:

Sumitomo Pharma America, Inc.

Conditions:

Insomnia

Generalized Anxiety Disorder

Eligibility:

All Genders

18-64 years

Phase:

PHASE4

Brief Summary

To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an a...

Detailed Description

An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder who will be treat...

Eligibility Criteria

Inclusion

  • Subjects, between the ages of 18 and 64 years inclusive
  • Subjects with Generalized Anxiety Disorder (GAD)
  • Subjects with insomnia related to GAD.

Exclusion

    Key Trial Info

    Start Date :

    June 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2006

    Estimated Enrollment :

    420 Patients enrolled

    Trial Details

    Trial ID

    NCT00235508

    Start Date

    June 1 2005

    End Date

    April 1 2006

    Last Update

    February 22 2012

    Active Locations (64)

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    Page 1 of 16 (64 locations)

    1

    Birmingham, Alabama, United States

    2

    Mesa, Arizona, United States

    3

    Scottsdale, Arizona, United States

    4

    Irvine, California, United States