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Long-Term Study of MP-214 in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01626872
First received: June 19, 2012
Last updated: April 5, 2017
Last verified: April 2017
June 19, 2012
April 5, 2017
June 2012
July 2016   (Final data collection date for primary outcome measure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 60 weeks ]
Same as current
Complete list of historical versions of study NCT01626872 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long-Term Study of MP-214 in Patients With Schizophrenia
Long-Term Extension Study of MP-214 in Patients With Schizophrenia
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Schizophrenia
  • Drug: MP-214 low dose
    Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
  • Drug: MP-214 middle dose
    Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
  • Drug: MP-214 high dose
    Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
  • Drug: Risperidone
    Participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts low or middle dose of MP-214) and will be re-randomized after Week 6 to low dose or middle dose of MP-214
  • Experimental: MP-214 low dose
    Intervention: Drug: MP-214 low dose
  • Experimental: MP-214 middle dose
    Intervention: Drug: MP-214 middle dose
  • Experimental: MP-214 high dose
    Intervention: Drug: MP-214 high dose
  • Active Comparator: Risperidone
    Intervention: Drug: Risperidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
254
October 2016
July 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
20 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   Taiwan
 
 
NCT01626872
A002-A5
Not Provided
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP