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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00095043 |
The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.
Condition | Intervention | Phase |
---|---|---|
Insomnia |
Drug: MK0928, gaboxadol Drug: Comparator: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Multicenter Long-Term Safety Study of MK-0928 in the Treatment of Elderly Outpatients With Primary Insomnia |
Estimated Enrollment: | 320 |
Study Start Date: | October 2004 |
The duration of treatment is 1 year.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study Director: | Medical Monitor | Merck |
Study ID Numbers: | 2004_088 |
Study First Received: | October 29, 2004 |
Last Updated: | July 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00095043 |
Health Authority: | United States: Food and Drug Administration |
4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol Sleep Initiation and Maintenance Disorders Mental Disorders |
Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Nervous System Diseases |