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Trial record 1 of 1 for:    NCT00366704
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Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint

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ClinicalTrials.gov Identifier: NCT00366704
Recruitment Status : Terminated
First Posted : August 21, 2006
Last Update Posted : February 11, 2013
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE August 17, 2006
First Posted Date  ICMJE August 21, 2006
Last Update Posted Date February 11, 2013
Study Start Date  ICMJE November 2006
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
The primary analysis will be the change from baseline on body weight at the final evaluation. [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
The primary analysis will be the change from baseline on body weight at the final evaluation.
Change History Complete list of historical versions of study NCT00366704 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Secondary outcomes include: Change from baseline in triglyceride level, Change from baseline in waist circumference, and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score. [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
Secondary outcomes include: Change from baseline in triglyceride level, Change from baseline in waist circumference, and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Parallel-group Fixed-dose Study of the Effect on Weight of Bifeprunox Versus Risperidone in the Treatment of Outpatients With Schizophrenia.
Brief Summary The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: bifeprunox
    .25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)
  • Drug: risperidone
    4mg, QD, 8 week treatment
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: bifeprunox
  • Active Comparator: B
    Intervention: Drug: risperidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: August 18, 2006)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Current treatment of at least 3 months with risperidone.
  • Primary diagnosis of schizophrenia.
  • Total Positive and Negative Symptoms Scale (PANSS) score < or = 70 at screening and baseline.

Exclusion criteria:

  • Psychiatric diagnosis other than schizophrenia as assessed by the modified Mini International Neuropsychiatric Interview (MINI) and considered by the investigator to be the primary psychiatric diagnosis.
  • History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
  • History of any suicide attempt within 3 years of day 1 or significant immediate risk of violence or suicidality.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366704
Other Study ID Numbers  ICMJE 3168A1-313
B3101009 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Solvay Pharmaceuticals
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP