CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 218 enrolled
Drug / intervention
OPC-34712 (4mg) +3 moredrug
Likely dose
OPC-34712 (4mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01423916
NCT01423916Phase 1Completed
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A Parallel-arm, Double-blind, Placebo and Positive Controlled Multiple Oral Dose Administration Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Aug 26, 2011·Updated Oct 29, 2015

In Brief

A Phase 1 clinical trial evaluating OPC-34712 (4mg), Moxifloxacin, and 2 other interventions for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 218 participants across 8 sites.

Detailed Summary

The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective subjects. The goals of this trial are three-fold: * To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for placebo * To determine the effect of moxifloxacin on QTcI * To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 26, 2011
Enrollment StartJul 1, 2011
Primary CompletionFeb 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.8 years ago

Interventions

OPC-34712 (4mg)drug

Arms assigned to this intervention receive 4mg.

Moxifloxacindrug

Arms assigned to this intervention will receive 400mg.

OPC-34712 (12mg)drug

Arms assigned to this intervention receive 12mg.

Placebodrug

OPC-34712 placebo