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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT01208233

Purpose

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.

Condition	Intervention	Phase
Ischemic Stroke	Drug: PF-03049423 Other: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety and tolerability assessed by an Independent Data and Safety Monitoring Board (DSMB) using data, including SAEs, AEs , vital signs, brain MRI, ECG, physical (including neurological) examination, NIHSS scores, laboratory tests. [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
Proportion of subjects with Modified Rankin Scale (mRS) less than or equal to 2 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma concentrations of PF-03049423 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Box and Blocks, Hand Grip Strength Test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Proportion of subjects with: mRS (0-1), NIHSS (0-1), NIHSS, BI, BI greater or equal to 95 and BI =100 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Domains of Interest: RBANS Coding Sub Test, RBANS Naming Sub Test, Line Cancellation, Recognition Memory Test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Gait Velocity [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	December 2010
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 mg PF-03049423	Drug: PF-03049423 1 mg of PF-03049423 daily for 90 days
Experimental: 3 mg of PF-03049423	Drug: PF-03049423 3 mg of PF-03049423 daily for 90 days
Experimental: 6 mg of PF-03049423	Drug: PF-03049423 6 mg of PF-03049423 daily for 90 days
Placebo Comparator: Placebo	Other: Placebo Placebo of PF-03049423 daily for 90 days

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208233

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 43 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01208233 History of Changes
Other Study ID Numbers:	A9541004
Study First Received:	September 22, 2010
Last Updated:	May 14, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Phase 2 Ischemic stroke Safety and efficacy

Additional relevant MeSH terms:

Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2012