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Bifeprunox in the Treatment of Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
bifeprunox
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring double-blind study in the treatment of schizophrenia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosis of schizophrenia understand nature of study able to be managed in out-patient setting for long-term bifeprunox treatment Exclusion Criteria: current primary diagnosis other than schizophrenia suicide risk diagnosis or history of substance abuse uncontrolled hypertension

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 11, 2005
    Last Updated
    January 15, 2015
    Sponsor
    Solvay Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193713
    Brief Title
    Bifeprunox in the Treatment of Schizophrenia
    Official Title
    A Randomized, Double-Blind, Olanzapine-Referenced, Parallel-Group Safety and Efficacy Study of Flexible Doses of Bifeprunox in the Long-term Treatment of Schizpohrenia (Extension of S1543003)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Solvay Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    double-blind study in the treatment of schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    bifeprunox

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of schizophrenia understand nature of study able to be managed in out-patient setting for long-term bifeprunox treatment Exclusion Criteria: current primary diagnosis other than schizophrenia suicide risk diagnosis or history of substance abuse uncontrolled hypertension
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Global Clinical Director Solvay
    Organizational Affiliation
    Solvay Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Bifeprunox in the Treatment of Schizophrenia

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