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
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Initiation and Maintenance Disorders
Intervention: zolpidem-MR (modified release) (Drug); zolpidem (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
ICD CSD, Study Director, Affiliation: Sanofi-Aventis
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Polysommography (PSG) wake time after sleep onset (WASO)
Secondary outcome: PSG parameters, Patient's sleep questionnaire, Patient's global impression, Relative degree of satisfaction with the different study drugs
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV) criteria
Locations and Contacts
Sanofi-Aventis Administrative Office, Macquarie Park, Australia
Sanofi-Aventis Administrative Office, Laval, Canada
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey 08807, United States
Additional Information
Starting date: September 2003
Last updated: March 5, 2008
|
