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Evaluation of the Long-Term Efficacy and Safety of Zolpidem-MR 12.5 mg Compared to Placebo, When Both Are Administered Over a Long-Term Period "as Needed", in Patients With Chronic Primary Insomnia
The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary insomnia. Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to placebo administered over a long-term period, on an as needed basis.
Age
18 - 64 years
Sex
ALL
Healthy Volunteers
No
Sanofi-Aventis
Malvern, Pennsylvania, United States
Start Date
August 1, 2004
Primary Completion Date
January 1, 2006
Completion Date
January 1, 2006
Last Updated
April 6, 2009
1,025
ACTUAL participants
zolpidem-MR (SL800750)
DRUG
Lead Sponsor
Sanofi
NCT03642028
NCT05965609
Data Source & Attribution
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