Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia

NCT ID: NCT00580125

Last Updated: 2012-04-18

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-09-30

Brief Summary

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The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.

Detailed Description

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Conditions

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Schizophrenia

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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A2

Group Type EXPERIMENTAL

PF-00217830

Intervention Type DRUG

PF-00217830 5 mg, oral capsule, once daily for 21 days

A5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo, oral capsule, once daily for 21 days

A4

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

Aripiprazole 15 mg, oral capsule, once daily for 21 days

A3

Group Type EXPERIMENTAL

PF-00217830

Intervention Type DRUG

PF-00217830 15 mg, oral capsule, once daily for 21 days

A1

Group Type EXPERIMENTAL

PF-00217830

Intervention Type DRUG

PF-00217830 2 mg, oral capsule, once daily for 21 days

Interventions

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PF-00217830

PF-00217830 5 mg, oral capsule, once daily for 21 days

Intervention Type DRUG

Placebo

Placebo, oral capsule, once daily for 21 days

Intervention Type OTHER

Aripiprazole

Aripiprazole 15 mg, oral capsule, once daily for 21 days

Intervention Type DRUG

PF-00217830

PF-00217830 15 mg, oral capsule, once daily for 21 days

Intervention Type DRUG

PF-00217830

PF-00217830 2 mg, oral capsule, once daily for 21 days

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Subjects with a current DSM-IV axis I diagnosis other than schizophrenia
* Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence
* Subjects with a history of treatment resistant schizophrenia
* Females of childbearing potential
Minimum Eligible Age

18 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

Garden Grove, California, United States

Site Status

Pfizer Investigational Site

Torrance, California, United States

Site Status

Pfizer Investigational Site

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

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Pfizer Investigational Site

Detroit, Michigan, United States

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Pfizer Investigational Site

Bridgeton, Missouri, United States

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Pfizer Investigational Site

Florissant, Missouri, United States

Site Status

Pfizer Investigational Site

Saint Charles, Missouri, United States

Site Status

Pfizer Investigational Site

Brooklyn, New York, United States

Site Status

Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Mangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Udupi, Karnataka, India

Site Status

Pfizer Investigational Site

Pune, Maharashtra, India

Site Status

Pfizer Investigational Site

Pune, , India

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Pfizer Investigational Site

Gatchina District, Leningradskaya Oblast', Russia

Site Status

Pfizer Investigational Site

Khot'kovo, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

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Pfizer Investigational Site

Saint Petersburg, , Russia

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Pfizer Investigational Site

Saint Petersburg, , Russia

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Pfizer Investigational Site

Simferopol, Autonomous Republic of Crimea, Ukraine

Site Status

Pfizer Investigational Site

Kiev, Ukraine, Ukraine

Site Status

Pfizer Investigational Site

Dnipropetrovsk, , Ukraine

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Pfizer Investigational Site

Donetsk, , Ukraine

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Pfizer Investigational Site

Kharkiv, , Ukraine

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Pfizer Investigational Site

Kharkiv, , Ukraine

Site Status

Pfizer Investigational Site

Kyiv, , Ukraine

Site Status

Pfizer Investigational Site

Luhansk, , Ukraine

Site Status

Countries

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United States India Russia Ukraine

Related Links

Other Identifiers

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A7251006

Identifier Type: -

Identifier Source: org_study_id

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