6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia

NCT00352144 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 830

Last updated 2012-02-22

No results posted yet for this study

Summary

To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.

Conditions

  • Primary Insomnia

Interventions

DRUG

Eszopiclone

Eszopiclone 3 mg

DRUG

Placebo

Placebo tablet

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2004-10-31
Completion
2004-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00352144 on ClinicalTrials.gov