Clinical trial
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and…
NCT00374777 · Astellas Pharma Inc, Industry · Completed
Key facts
| NCT number | NCT00374777 |
|---|---|
| Title | A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients |
| Official title | FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Placebo- and Nitrazepam-Controlled, Group-Comparison Study in Patients With Insomnia Associated With Schizophrenia and Manic-Depressive Psychosis |
| Lead sponsor | Astellas Pharma Inc, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Sleep Initiation and Maintenance Disorders |
| Intervention type | Drug |
| Interventions | zolpidem MR, nitrazepam, placebo |
| Enrollment | 450 |
| Start date | Aug 1, 2006 |
| Primary completion | May 1, 2008 |
| Completion | Jun 1, 2008 |
| First posted | Sep 11, 2006 |
| Last update posted | Aug 20, 2014 |
| Countries | Japan |
At a glance
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: