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NCT01649557 · ClinicalTrials.gov registry record · Phase 2

Multicenter, Open-label, Safety and Tolerability Study

A Phase 2 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 2
Development phase
244
Enrollment target
20
Study locations

NCT01649557 is a Phase 2 study of Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 244 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT01649557, a Phase 2 study of Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 2
Development phase
244 participants
Enrollment target
20
Study locations

Study 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 Studied

Schizophrenia

Interventions

  • DRUG OPC-34712

Study Locations (20)

California

  • Otsuka Investigational Site - Escondido
  • Otsuka Investigational Site - Garden Grove
  • Otsuka Investigational Site - Long Beach
  • Otsuka Investigational Site - Oceanside
  • Otsuka Investigational Site - Pasadena
  • Otsuka Investigational Site - San Diego
  • Otsuka Investigational Site - San Diego
  • Otsuka Investigational Site - Santa Ana

Other

  • Otsuka Investigational Site - Burgas
  • Otsuka Investigational Site - Kazanlak
  • Otsuka Investigational Site - Pazardzhik
  • Otsuka Investigational Site - Plovdiv

Florida

  • Otsuka Investigational Site - Bradenton
  • Otsuka Investigational Site - Maitland

Arkansas

  • Otsuka Investigational Site - Little Rock

District of Columbia

  • Otsuka Investigational Site - Washington D.C.

Missouri

  • Otsuka Investigational Site - St Louis

New York

  • Otsuka Investigational Site - Cedarhurst

Pennsylvania

  • Otsuka Investigational Site - Philadelphia

Trial Details

FieldValue
Enrollment Target 244 participants
Start Date 2009-08
Est. Completion 2011-09
Phase Phase 2

Sponsor

Otsuka Pharmaceutical Development & Commercialization

221 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01649557

The ClinicalTrials.gov registry entry for NCT01649557 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (12% higher). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which OPC-34712 is the first listed.

NCT01649557 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Other, Florida.

Frequently Asked Questions

What is clinical trial NCT01649557 about?

NCT01649557 is a clinical study titled "Multicenter, Open-label, Safety and Tolerability Study". 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 c...

What is the current status of trial NCT01649557?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 244 participants. The study started on 2009-08. Estimated completion is 2011-09.

What conditions does trial NCT01649557 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT01649557?

The interventions under investigation include: OPC-34712 (DRUG).

Who is sponsoring clinical trial NCT01649557?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01649557 being conducted?

This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.