Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)
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 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi-Aventis
Summary
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12.
Secondary outcome: Main secondary variables are the Clinical Global Impression (CGI) improvement item and to items 2, 3, and 4 of the PGI scale at week 12.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients with chronic primary insomnia
The investigator will evaluate whether there are other reasons why a patient may not
participate.
Locations and Contacts
Sanofi-Aventis, Malvern, Pennsylvania 19355, United States
Additional Information
Starting date: August 2004
Last updated: March 5, 2008
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