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COMPLETED Phase 2

Multicenter, Open-label, Safety and Tolerability Study

NCT01649557 · View on ClinicalTrials.gov ↗

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

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

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01649557 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01649557?

The interventions under investigation include: OPC-34712 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01649557?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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