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bifeprunox, olanzapine

Phase 3

Schizophrenia | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Dec 27, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

bifeprunox, olanzapine · 2 trials · 1 indication

Phase 3 2
NCT00366171Open Label Extension Study of BifeprunoxSchizophrenia
COMPLETED120 Analytics
NCT00380224Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.Schizophrenia
COMPLETED120 Analytics
PHASE3COMPLETED
Open Label Extension Study of Bifeprunox
SchizophreniaUnlock trial analytics
PHASE3COMPLETED
Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in body weight from baseline/first dose of bifeprunox at each observation.
Change from baseline on body weight at the final evaluation.

Secondary Endpoints

Change from baseline/first dose of bifeprunox for triglyceride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression (CGI)-Score, and waist circumference at each observation.
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.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
BifeprunoxDRUG -
bifeprunox, olanzapineDRUG -
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Eligibility Criteria

Age Range18 Years to 66 Years
SexALL
Healthy VolunteersNo
Study Sites83

Inclusion Criteria: 1. Outpatients who have successfully completed Wyeth study 3168A1-311-US. 2. A signed and dated informed consent form for this study. 3. No major protocol violations in previous study. Exclusion Criteria: 1. Clinically important abnormalities noted in preceding short-term stud...

Countries:United States
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Frequently asked questions about bifeprunox, olanzapine

What is Bifeprunox used for?

Bifeprunox is an investigational small molecule being studied for psychiatric conditions, including bipolar depression, schizophrenia, and bipolar disorder. It has been evaluated in clinical trials for these indications, though it is not approved and remains in clinical development.

Who is developing Bifeprunox?

Bifeprunox is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug has been studied in Phase 3 clinical trials for psychiatric indications.

What phase is Bifeprunox in?

Bifeprunox has been studied in Phase 3 clinical trials for bipolar depression and schizophrenia, as well as in a Phase 1 trial in healthy subjects. It is an investigational drug and is not approved for any use.

What clinical trials is Bifeprunox in?

Bifeprunox has been evaluated in several completed trials, including NCT00245973 for bipolar depression, NCT00366171 and NCT00380224 for schizophrenia, and NCT00581451 in healthy subjects. These trials were conducted in the United States and enrolled adults aged 18 years and older.

Is Bifeprunox the same as any other drug?

Bifeprunox is a distinct investigational compound developed by Pfizer. No alternative names for Bifeprunox have been reported in the clinical trial records.