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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00630175 |
The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionnaires.
The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.
Condition | Intervention | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders |
Drug: zolpidem-MR (modified release) Drug: zolpidem Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia. A Double-Blind, Randomized, Placebo-Controlled,Three Way Cross-Over Study |
Enrollment: | 113 |
Study Start Date: | September 2003 |
Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Australia | |
Sanofi-Aventis Administrative Office | |
Macquarie Park, Australia | |
Canada | |
Sanofi-Aventis Administrative Office | |
Laval, Canada |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC5202, SL800750 |
Study First Received: | February 26, 2008 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00630175 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration |
Insomnia |
Zolpidem Sleep Initiation and Maintenance Disorders Mental Disorders |
Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses GABA Agonists Hypnotics and Sedatives Physiological Effects of Drugs |
Nervous System Diseases Central Nervous System Depressants GABA Agents Central Nervous System Agents Pharmacologic Actions |