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A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia

NCT ID: NCT00977522

Last Updated: 2012-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-09-30

Brief Summary

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This study is examining the efficacy of PF-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with schizophrenia.

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Detailed Description

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The study was terminated on August 25, 2010 because the study's scientific validity could no longer be supported. The decision to terminate the trial was not based on any safety concerns.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PF-03463275

Group Type EXPERIMENTAL

PF-03463275

Intervention Type DRUG

30 mg Controlled Release tablet BID for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet BID

Interventions

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PF-03463275

30 mg Controlled Release tablet BID for 12 weeks

Intervention Type DRUG

Placebo

Placebo tablet BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype in the residual phase.
* Subjects must be in ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone, or aripiprazole. Subjects must be on a stable medication treatment regimen for at least 2 months.
* Evidence of stable symptomatology at least 3 months.

Exclusion Criteria

* Female subjects who are pregnant or breastfeeding.
* Subjects with evidence or history of a clinically significant medical condition which would increase risk or which could interfere with the interpretation of trial results.
* Subjects who have DSM IV defined psychoactive substance dependence (including alcohol and excluding nicotine and caffeine dependence) within 12 months of screening or substance abuse within 3 months prior to screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Cerritos, California, United States

Site Status

Pfizer Investigational Site

Chula Vista, California, United States

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Pfizer Investigational Site

Escondido, California, United States

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Pfizer Investigational Site

Garden Grove, California, United States

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Pfizer Investigational Site

Glendale, California, United States

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Pfizer Investigational Site

Long Beach, California, United States

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Pfizer Investigational Site

Long Beach, California, United States

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Pfizer Investigational Site

National City, California, United States

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Paramount, California, United States

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Torrance, California, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Pfizer Investigational Site

Atlanta, Georgia, United States

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Pfizer Investigational Site

Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Park Ridge, Illinois, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Pfizer Investigational Site

Flowood, Mississippi, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Pfizer Investigational Site

Runnemede, New Jersey, United States

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Toms River, New Jersey, United States

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Willingboro, New Jersey, United States

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Pfizer Investigational Site

Fresh Meadows, New York, United States

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Pfizer Investigational Site

Holliswood, New York, United States

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Pfizer Investigational Site

Staten Island, New York, United States

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Pfizer Investigational Site

Staten Island, New York, United States

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Pfizer Investigational Site

Edmond, Oklahoma, United States

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Pfizer Investigational Site

Oklahoma City, Oklahoma, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

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Pfizer Investigational Site

Memphis, Tennessee, United States

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Pfizer Investigational Site

Austin, Texas, United States

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Pfizer Investigational Site

Austin, Texas, United States

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Pfizer Investigational Site

Bellaire, Texas, United States

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Pfizer Investigational Site

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9131005&StudyName=A%20Study%20Of%20PF-03463275%20As%20Add-On%20Therapy%20In%20Outpatients%20With%20Persistent%20Negative%20Symptoms%20Of%20Schizophrenia

To obtain contact information for a study center near you, click here.

Other Identifiers

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A9131005

Identifier Type: -

Identifier Source: org_study_id

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