Long-Term Study of MP-214 in Patients With Schizophrenia
This trial is active, not recruiting.
|Treatments||mp-214 low dose, mp-214 middle dose, mp-214 high dose, risperidone|
|Phase||phase 2/phase 3|
|Sponsor||Mitsubishi Tanabe Pharma Corporation|
|Start date||June 2012|
|End date||July 2016|
|Trial size||254 participants|
|Trial identifier||NCT01626872, A002-A5|
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: 60 weeks
Male or female participants from 20 years up to 64 years old.
Inclusion Criteria: - Written informed consent obtained from the patient before the completion of Study A002-A4 - Patients who have completed the A002-A4 study Exclusion Criteria: - Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events (AEs), as judged by the investigator (or subinvestigator)
|Official title||Long-Term Extension Study of MP-214 in Patients With Schizophrenia|
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