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Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo

NCT ID: NCT00570063

Last Updated: 2017-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-02-18

Brief Summary

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To assess the efficacy and safety of an investigational compound PF-02545920 for the treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing symptoms associated with schizophrenia.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizophrenia acute exacerbation and PF-02545920

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

PF-02545920 15 mg tablets taken twice a day by mouth for 21 days

Group Type PLACEBO_COMPARATOR

PF-02545920

Intervention Type DRUG

Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days

2

Matching placebo tablets taken twice a day by mouth for 21 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days.

Interventions

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PF-02545920

Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days

Intervention Type DRUG

Placebo

Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Have a current diagnosis of schizophrenia.
2. Increase in symptoms over the past 2-4 weeks.
3. Willing to remain inpatients for the duration of the trial.

Exclusion Criteria

1. Evidence or history of clinically significant medical problems.
2. Females of childbearing potential.
3. A primary psychiatric diagnosis other than schizophrenia.
4. A diagnosis of substance abuse or dependence in the last 6 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 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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California Clinical Trials Medical Group, Inc.

Glendale, California, United States

Site Status

Glendale Adventist Medical Center

Glendale, California, United States

Site Status

Telecare-Cresta Loma

Lemon Grove, California, United States

Site Status

California Clinical Trials Medical Group

Paramount, California, United States

Site Status

LaPaz Geropsychiatric Center

Paramount, California, United States

Site Status

California Clinical Trials Medical Group

San Diego, California, United States

Site Status

Connecticut Mental Health Center-Yale University, Clinical Neuroscience Research Unit

New Haven, Connecticut, United States

Site Status

CRI Worldwide, LLC

Willingboro, New Jersey, United States

Site Status

St. Anthony Hospital

Oklahoma City, Oklahoma, United States

Site Status

IPS Research Company

Oklahoma City, Oklahoma, 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=A8241006&StudyName=Double%20Blind%2C%20Randomized%2C%203%20Week%20Inpatient%20Study%20To%20Evaluate%20The%20Safety%20%26%20Efficacy%20Of%20PF-02545920%20Compared%20With%20Placebo

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Other Identifiers

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A8241006

Identifier Type: -

Identifier Source: org_study_id