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Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint

This study has been terminated.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00366704
First received: August 17, 2006
Last updated: February 7, 2013
Last verified: April 2008
History of Changes

August 17, 2006
February 7, 2013
November 2006
March 2008   (final data collection date for primary outcome measure)
The primary analysis will be the change from baseline on body weight at the final evaluation. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
The primary analysis will be the change from baseline on body weight at the final evaluation.
Complete list of historical versions of study NCT00366704 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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.
Not Provided
Not Provided
 
Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint
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.

The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: bifeprunox
    .25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)
  • Drug: risperidone
    4mg, QD, 8 week treatment
  • Experimental: A
    Intervention: Drug: bifeprunox
  • Active Comparator: B
    Intervention: Drug: risperidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00366704
3168A1-313, B3101009
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Solvay Pharmaceuticals
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2008

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