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...
Brief Summary
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 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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: January 2006
Intervention(s) in this Clinical Trial
- Drug: zolpidem-MR (SL800750)
Outcome Measures for this Clinical Trial
Primary Measures
- The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12.
Secondary Measures
- 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.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- patients with chronic primary insomnia
- The investigator will evaluate whether there are other reasons why a patient may not participate.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 64 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
ICD CSD Study Director Sanofi-Aventis
Related Publications
Citations Reporting Results
Krystal AD, Erman M, Zammit GK, Soubrane C, Roth T; ZOLONG Study Group. Long-term efficacy and safety of zolpidem extended-release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: a 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Sleep. 2008 Jan 1;31(1):79-90.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00425243
Study ID Number: LTE5407
ClinicalTrials.gov Identifier: NCT00425243
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00425243
