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NCT01423916 · ClinicalTrials.gov registry record · Phase 1
Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
A Phase 1 study of Schizophrenia and Schizoaffective Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 218
- Enrollment target
- 8
- Study locations
NCT01423916 is a Phase 1 study of Schizophrenia and Schizoaffective Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 218 participants, roughly in line with the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target. The trial reports 8 study locations across 7 states.
The verdict
NCT01423916, a Phase 1 study of Schizophrenia and Schizoaffective Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 218 participants
- Enrollment target
- 8
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG OPC-34712 (4mg)
- DRUG OPC-34712 (12mg)
Study Locations (8)
California
- Otsuka Investigational Site - Long Beach
- Otsuka Investigational Site - San Diego
Florida
- Otsuka Investigational Site - Fort Lauderdale
Kansas
- Otsuka Investigational Site - Overland Park
Maryland
- Otsuka Investigational Site - Rockville
Missouri
- Otsuka Investigational Site - St Louis
Pennsylvania
- Otsuka Investigational Site - Philadelphia
Texas
- Otsuka Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01423916
The ClinicalTrials.gov registry entry for NCT01423916 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01423916 reports 8 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Kansas.
Frequently Asked Questions
What is clinical trial NCT01423916 about?
NCT01423916 is a clinical study titled "Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder". 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 (Q...
What is the current status of trial NCT01423916?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 218 participants. The study started on 2011-07. Estimated completion is 2012-03.
What conditions does trial NCT01423916 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder.
What interventions are being tested in trial NCT01423916?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), OPC-34712 (4mg) (DRUG), OPC-34712 (12mg) (DRUG).
Who is sponsoring clinical trial NCT01423916?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01423916 being conducted?
This trial has 8 study locations across California, Florida, Kansas, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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