Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia
- Sponsor
- Tanabe Pharma Corporation
- Study ID
- NCT00862992
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cariprazine 3 mg — DRUG
- Cariprazine 6 mg — DRUG
- Cariprazine 12.5 mg — DRUG
Study Details
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.
Key Dates
- Start date
- Apr 30, 2008
- Status verified
- Dec 2025
- Primary completion
- Sep 30, 2009
- Completion
- Sep 30, 2009
Study Design
- Enrollment
- 34 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 1
- Experimental: 2
- Experimental: 3
Primary Outcome Measure
Number of Participants With Adverse Event and Adverse Drug Reaction [ Time Frame: Up to 7 weeks ]
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