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MP-214 in schizophrenia
NCT01626859Phase 3
Key facts
- Status
- Completed
- Start
- May 2012
- Primary completion
- Aug 2013
- Countries
- 1
- Sponsor
- Mitsubishi Tanabe Pharma
- Modality
- Orthosteric Ligands
- Drugs
- cariprazine
- Conditions
- schizophrenia
01
Overview
Phase 3, open-label trial of cariprazine in schizophrenia (3 arms), sponsored by Mitsubishi Tanabe Pharma. Primary endpoints: Adverse Events at 24 weeks, Maximum Plasma Concentration at 12 weeks and 2 more. Started May 2012; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
MP-214 3mg
Once daily oral 3mg MP-214 for 12 weeks
MP-214 6mg
Once daily oral 6mg MP-214 for 12 weeks
MP-214 9mg
Once daily oral 9mg MP-214 for 12 weeks
03
Who it enrols
Adults diagnosed with schizophrenia per DSM-IV-TR criteria with normal physical examination, laboratory values, vital signs, and ECG. Excludes patients with schizoaffective disorder, schizophreniform disorder, other psychotic disorders, or bipolar I or II disorder.
04
Endpoints
Primary
Adverse Events
Maximum Plasma Concentration
Time to Maximum Plasma Concentration
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours
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