Overview

A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
Summary
A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Treatments:
Nitrazepam
Zolpidem
Criteria
Inclusion Criteria:

- Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.

Exclusion Criteria:

- Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious
cardiac disorders; serious hepatic impairment; serious renal diseases.