Status:
WITHDRAWN
A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
Lead Sponsor:
Pfizer
Conditions:
Insomnia
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be random...
Eligibility Criteria
Inclusion
- 3 month history of primary insomnia
- Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)
Exclusion
- Any history of psychiatric diagnosis
- History or presence of any breathing related sleep disorder
- History or presence of any medical or neurological condition that could interfere with sleep
- Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00748592
Start Date
January 1 2009
End Date
June 1 2009
Last Update
February 12 2009
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