Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)

Phase 3

Completed

• Conditions: Primary Insomnia

• Registration Number: NCT00094627
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-10-21
• Study First Submitted QC: 2004-10-21
• Study First Posted: 2004-10-22
• Study Start: 2004-11
• Study Completion: 2006-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 465

Inclusion Criteria

• Adult patients with a diagnosis of primary insomnia and in good physical and mental health

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Exclusion Criteria

• Adult patients with other medical , neurological and sleep disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amount of time spent awake and time to fall asleep at night after 2 days	After 2 days

Secondary Outcome Measures

Name	Time	Method
Amount of time spent awake and time to fall asleep at night after 30 days	After 30 days
Amount of deep sleep after 2 days	After 2 days