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Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia

NCT01397786 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1044

Last updated 2017-05-10

Study results available
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Summary

The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.

Conditions

Interventions

DRUG

OPC-34712

Phase A: 1-2 mgs/day by mouth, max of 4 wks. Phase B: 1-4 mgs/day by mouth, up to 52 weeks

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Aleksandar Skuban, M.D. · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Canada
  • Colombia
  • Croatia
  • Japan
  • Latvia
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Korea
  • Taiwan
  • Turkey (Türkiye)
  • 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 NCT01397786 on ClinicalTrials.gov