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

Completed · Phase 3 · Has a placebo group

Conditions studied: Sleep Initiation and Maintenance Disorders

In brief

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.

Key facts

Study ID

NCT00630175

Run by

Sanofi

People needed

113

Starts

2003-09-01

Expected to finish

2004-02-01

Last updated by the study team

2009-05-18

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Macquarie Park, Australia
• Sanofi-Aventis Administrative Office — Laval, Canada

Full record on ClinicalTrials.gov

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