Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)
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|ClinicalTrials.gov Identifier: NCT00425243|
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : April 6, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Initiation and Maintenance Disorders||Drug: zolpidem-MR (SL800750)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1025 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||August 2004|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425243
|United States, Pennsylvania|
|Malvern, Pennsylvania, United States, 19355|
|Study Director:||ICD CSD||Sanofi|