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Multicenter, Open-label, Safety and Tolerability Study

NCT01649557 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2015-10-29

Study results available
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Summary

This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.

Conditions

Interventions

DRUG

OPC-34712

oral administered once daily

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • United States
  • Bulgaria
  • Croatia
  • India
  • Philippines
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01649557 on ClinicalTrials.gov