SchizophreniaPhase 3NCT00366327
Study Evaluating Bifeprunox in Patients With Schizophrenia.
A Phase 3 study testing Bifeprunox in people with Schizophrenia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 82 sites in United States.
Trial summary
An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Bifeprunox
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 82 sitesUnited States
- Study dates
- Jan 2007to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients who have successfully completed Wyeth study 3168A1-313.
- A signed and dated informed consent form for this study.
- No major protocol violations in the previous study.
Who cannot join
- Clinically important abnormalities in the preceding short-term study that have not resolved.
- Use of prohibited treatments in the preceding short-term study.
- Meeting any exclusion criteria in the preceding short-term study
Trial locations and contacts
82 sites in 1 country.
82 sites in 1 country
United States82 sites
Study site
Anaheim, California, 92802
Study site
Anaheim, California, 92804
Study site
Anaheim, California, 92805
Study site
Atlanta, Georgia, 30307
Study site
Atlanta, Georgia, 30308
Study site
Austin, Texas, 78756
Study site
Beachwood, Ohio, 44122
Study site
Boynton Beach, California, 33426
Study site
Brooklyn, New York, 11203
Study site
Buena Park, California, 90620
Study site
Buffalo, New York, 14215
Study site
Butner, North Carolina, 27509
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Cerritos, California, 90703
Study site
Cherry Hill, New Jersey, 08002
Study site
Chicago, Illinois, 60631
Study site
Clementon, New Jersey, 08021
Study site
Cleveland, Ohio, 44109
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Coevr d'Alene, Idaho, 83814
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Cordova, Tennessee, 38018
Study site
Costa Mesa, California, 92363
Study site
Costa Mesa, California, 92627
Study site
DeSoto, Texas, 75115
Study site
East Stroudsburg, Pennsylvania, 18301
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Escondido, California, 92025
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Farmington, Connecticut, 06030
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Flowood, Mississippi, 39232
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Fort Lauderdale, Florida, 33319
Study site
Gaithersburg, Maryland, 20877
Study site
Garden Grove, California, 92845
Study site
Glendale, California, 91206
Study site
Hartford, Connecticut, 06106
Study site
Hialeah, Florida, 33016
Study site
Hoffman Estates, Illinois, 60194
Study site
Houston, Texas, 77007
Study site
Huntington Beach, California, 92648
Study site
Indiannapolis, Indiana, 46202
Study site
Irving, Texas, 75062
Study site
Jacksonville, Florida, 32207
Study site
Jacksonville, Florida, 32256
Study site
Jenkintown, Pennsylvania, 19046
Study site
Joliet, Illinois, 60077
Study site
Kirkland, Washington, 98033
Study site
La Mesa, California, 91942
Study site
Lake Charles, Louisiana, 70601
Study site
Little Rock, Arkansas, 72201
Study site
Little Rock, Arkansas, 72211
Study site
Marietta, Georgia, 30060
Study site
Memphis, Tennessee, 38105
Study site
Memphis, Tennessee, 38157
Study site
Morehead City, North Carolina, 28557
Study site
Naperville, Illinois, 60540
Study site
National City, California, 91950
Study site
New London, Connecticut, 06320
Study site
Norristown, Pennsylvania, 19401
Study site
North Miami, Florida, 33161
Study site
North Platte, Nebraska, 69101
Study site
Oceanside, California, 92056
Study site
Oklahoma City, Oklahoma, 73139
Study site
Orange City, Florida, 32763
Study site
Paramount, California, 90723
Study site
Philadelphia, Pennsylvania, 19149
Study site
Pittsburgh, Pennsylvania, 15108
Study site
Pittsfield, Massachusetts, 01201
Study site
Rochester, New York, 14624
Study site
Rosemead, California, 91770
Study site
Sacramento, California, 95823
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92108
Study site
San Diego, California, 92123
Study site
San Diego, California, 92126
Study site
Santa Ana, California, 92701
Study site
Santa Ana, California, 92705
Study site
St Louis, Missouri, 63104
Study site
St Louis, Missouri, 63110
Study site
St Louis, Missouri, 63118
Study site
St Louis, Missouri, 63128
Study site
St. Petersburg, Florida, 33711
Study site
Staten Island, New York, 10312
Study site
Tampa, Florida, 33613
Study site
Torrance, California, 90505
Study site
Towson, Maryland, 21286
Study site
Worcester, Massachusetts, 01605
About this study
Official title: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.
An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.
- Conditions
- Schizophrenia
- Being tested
- Bifeprunox
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BifeprunoxDrug
Flex dose (20 or 30 mg)tablet, QD for 1 year
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Bifeprunox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight from baseline/first dose of bifeprunox at each observation.
Measured: 1 year
Secondary outcomes (1)
Change from baseline/first dose of bifeprunox in trigyleride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impressions (CGI) score, and waist circumference at each observation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366327
- Sponsor's protocol ID
- 3168A1-314
- Other IDs
- B3101010
- Status last verified
- Apr 2008
- First submitted
- 17 Aug 2006
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.
- ClinicalTrials.gov ID
- NCT00366327
- Acronym / sponsor ID
- 3168A1-314
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 21 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Bifeprunox |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients who have successfully completed Wyeth study 3168A1-313.
- A signed and dated informed consent form for this study.
- No major protocol violations in the previous study.
Key exclusion criteria (3 listed)
- Clinically important abnormalities in the preceding short-term study that have not resolved.
- Use of prohibited treatments in the preceding short-term study.
- Meeting any exclusion criteria in the preceding short-term study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BifeprunoxFlex dose (20 or 30 mg)tablet, QD for 1 year | Drug | A |
Primary outcome
Change in weight from baseline/first dose of bifeprunox at each observation.
Time frame: 1 year
1 secondary outcome
Change from baseline/first dose of bifeprunox in trigyleride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impressions (CGI) score, and waist circumference at each observation.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
82 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bifeprunox in people with Schizophrenia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 82 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight from baseline/first dose of bifeprunox at each observation. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.