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

This study has been terminated.
(See termination reason in detailed description.)
Information provided by (Responsible Party):
Pfizer Identifier:
First received: September 22, 2010
Last updated: January 30, 2014
Last verified: January 2014
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 ]

Enrollment: 181
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 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

Detailed Description:
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01208233

  Show 58 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01208233     History of Changes
Other Study ID Numbers: A9541004 
Study First Received: September 22, 2010
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 2 Ischemic stroke Safety and efficacy

Additional relevant MeSH terms:
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases processed this record on February 04, 2016