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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00296790 |
Purpose
A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with Escitalopram (Lexapro - antidepressant).
| Condition | Intervention | Phase |
|---|---|---|
|
Insomnia |
Drug: zolpidem tartrate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Estimated Enrollment: | 372 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | February 2007 |
Eligibility| Ages Eligible for Study: | 21 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00296790 History of Changes |
| Other Study ID Numbers: | PM_L_0167 |
| Study First Received: | February 23, 2006 |
| Last Updated: | October 11, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders Zolpidem Hypnotics and Sedatives Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |