A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia

NCT ID: NCT01829048

Last Updated: 2018-08-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-06

Study Completion Date

2013-10-17

Brief Summary

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To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/- other adjunctive medication.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-02545920

Group Type EXPERIMENTAL

PF-02545920

Intervention Type DRUG

15 mg (2 mg X 2d, 5 mg X 2d, 8 mg X 3 d, then 15 mg) Q12h

PF-02545920

Intervention Type DRUG

15 mg (5 mg X 2d, 10 mg X 2d, then 15 mg) Q12h

PF-02545920

Intervention Type DRUG

15 mg (5 mg BID for 7 days 10 mg BID for 7 days, then 15 mg BID for 4 days) Q12h

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Q12h

Interventions

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PF-02545920

15 mg (2 mg X 2d, 5 mg X 2d, 8 mg X 3 d, then 15 mg) Q12h

Intervention Type DRUG

PF-02545920

15 mg (5 mg X 2d, 10 mg X 2d, then 15 mg) Q12h

Intervention Type DRUG

PF-02545920

15 mg (5 mg BID for 7 days 10 mg BID for 7 days, then 15 mg BID for 4 days) Q12h

Intervention Type DRUG

Placebo

Placebo Q12h

Intervention Type DRUG

Other Intervention Names

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Cohort 1 Cohort 2 Cohort 3

Eligibility Criteria

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Inclusion Criteria

* Psychiatrically stable subjects with schizophrenia.
* Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
* Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.

Exclusion Criteria

* History of seizures or of a condition with risk of seizures.
* Subjects who have had electroconvulsive therapy within the 6 months prior to randomization.
* Pregnant or nursing females, and females of child bearing potential.
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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California Clinical Trials Medical Group

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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A8241018

Identifier Type: -

Identifier Source: org_study_id

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