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

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NCT00366704

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Little Rock, Arkansas, 72201 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Current treatment of at least 3 months with risperidone.

- Primary diagnosis of schizophrenia.

- Total Positive and Negative Symptoms Scale (PANSS) score baseline.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00366704
Pfizer
Terminated
Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint

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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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00366704
3168A1-313
B3101009 ( Other Identifier: Pfizer )
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

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