Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)
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.
|Sleep Initiation and Maintenance Disorders||Drug: zolpidem-MR (SL800750)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|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|
- The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12.
- 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.
|Study Start Date:||August 2004|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425243
|United States, Pennsylvania|
|Malvern, Pennsylvania, United States, 19355|
|Study Director:||ICD CSD||Sanofi|