A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
NCT01181232 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2014-09-10
Summary
The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.
Conditions
- Sleep Initiation and Maintenance Disorders
- Primary Insomnia
Interventions
- DRUG
-
Zolpidem MR
oral
- DRUG
-
Zolpidem IR
oral
Sponsors & Collaborators
-
Astellas Pharma Taiwan, Inc.
collaborator INDUSTRY -
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Use Central Contact · Astellas Pharma Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2011-04-30
- Completion
- 2011-04-30
Countries
- Taiwan
Study Locations
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