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Study Evaluating The Safety A...

Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke

NCT ID: NCT01208233

Last Updated: 2016-02-19

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke. The study will also evaluate the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following 90 days of therapy. The study will also explore the relationship between PF-03049423 concentration and blood pressure.

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Detailed Description

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The interim analysis for the POC study A9541004 demonstrated futility, and the study was stopped on the 6th of November 2013. There were no signals of serious safety concern.

Conditions

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Ischemic Stroke

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 mg PF-03049423

Group Type EXPERIMENTAL

PF-03049423

Intervention Type DRUG

1 mg of PF-03049423 daily for 90 days

3 mg of PF-03049423

Group Type EXPERIMENTAL

PF-03049423

Intervention Type DRUG

3 mg of PF-03049423 daily for 90 days

6 mg of PF-03049423

Group Type EXPERIMENTAL

PF-03049423

Intervention Type DRUG

6 mg of PF-03049423 daily for 90 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo of PF-03049423 daily for 90 days

Interventions

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PF-03049423

1 mg of PF-03049423 daily for 90 days

Intervention Type DRUG

PF-03049423

3 mg of PF-03049423 daily for 90 days

Intervention Type DRUG

PF-03049423

6 mg of PF-03049423 daily for 90 days

Intervention Type DRUG

Placebo

Placebo of PF-03049423 daily for 90 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of ischemic stroke with an onset within 72 hours prior to start of study agent administration, male or female.
* Supratentorial ischemic stroke involving the cortex documented by neurological exam and confirmed by MRI.
* Stroke involving upper extremity.
* Subjects who received thrombolytic therapy may be enrolled and the use of antiplatelet is acceptable.

Exclusion Criteria

* Any other severe acute or chronic medical or psychiatric condition besides the stroke.
* Women of child bearing potential.
* Uncontrolled hypertension.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

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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Spain Rehabilitation Center

Birmingham, Alabama, United States

Site Status

The Kirklin Clinic

Birmingham, Alabama, United States

Site Status

University Hospital

Birmingham, Alabama, United States

Site Status

Broward Health North

Deerfield Beach, Florida, United States

Site Status

Neurologic Consultant, P.A.

Fort Lauderdale, Florida, United States

Site Status

Fawcett Memorial Hospital

Port Charlotte, Florida, United States

Site Status