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Study Evaluating Bifeprunox in Patients With Schizophrenia.

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bifeprunox
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Change in weight from baseline/first dose of bifeprunox at each observation.

Secondary Outcome Measures

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.

Full Information

First Posted
August 17, 2006
Last Updated
February 7, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00366327
Brief Title
Study Evaluating Bifeprunox in Patients With Schizophrenia.
Official Title
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bifeprunox
Intervention Description
Flex dose (20 or 30 mg)tablet, QD for 1 year
Primary Outcome Measure Information:
Title
Change in weight from baseline/first dose of bifeprunox at each observation.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92802
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
City
Boynton Beach
State/Province
California
ZIP/Postal Code
33426
Country
United States
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92363
Country
United States
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
City
Rosemead
State/Province
California
ZIP/Postal Code
91770
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30307
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Coevr d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60631
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
City
Indiannapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14624
Country
United States
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
City
Butner
State/Province
North Carolina
ZIP/Postal Code
27509
Country
United States
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73139
Country
United States
City
East Stroudsburg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15108
Country
United States
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38157
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Bifeprunox in Patients With Schizophrenia.

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