Trials / Completed
CompletedNCT00999219
A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia
FK199B (Zolpidem MR Tablet) Phase III Clinical Study - A Double-Blind, Crossover, Comparative Polysomnographic Study Using Zolpidem (Myslee®) as a Positive Control in Patients With Insomnia, Excluding Patients With Schizophrenia or Manic-Depressive Psychosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 20 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FK199B | oral |
| DRUG | Zolpidem | oral |
Timeline
- Start date
- 2006-03-01
- Primary completion
- 2007-07-01
- Completion
- 2007-07-01
- First posted
- 2009-10-21
- Last updated
- 2014-08-20
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00999219. Inclusion in this directory is not an endorsement.