Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)

Phase 3

Terminated

• Conditions: Primary Insomnia

• Registration Number: NCT00094666
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

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
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

Not provided

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 two days

Secondary Outcome Measures

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