Trial record 1 of 2 for:    PF-03049423
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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.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01208233
First received: September 22, 2010
Last updated: January 30, 2014
Last verified: January 2014
  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 ]

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.

  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
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 ClinicalTrials.gov identifier: NCT01208233

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-3280
United States, Florida
Pfizer Investigational Site
Deerfield Beach, Florida, United States, 33064
Pfizer Investigational Site
Fort Lauderdale, Florida, United States, 33308
Pfizer Investigational Site
Port Charlotte, Florida, United States, 33952
United States, Georgia
Pfizer Investigational Site
Columbus, Georgia, United States, 31907
Pfizer Investigational Site
Columbus, Georgia, United States, 31909
Pfizer Investigational Site
Columbus, Georgia, United States, 31901
Pfizer Investigational Site
Columbus, Georgia, United States, 31904
United States, Indiana
Pfizer Investigational Site
Fort Wayne, Indiana, United States, 46805
Pfizer Investigational Site
Fort Wayne, Indiana, United States, 46845
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, North Carolina
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27514
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27599-7025
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Pfizer Investigational Site
Hershey, Pennsylvania, United States, 17033
Pfizer Investigational Site
Hummelstown, Pennsylvania, United States, 17036
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Bulgaria
Pfizer Investigational Site
Pleven, Bulgaria, 5800
Pfizer Investigational Site
Plovdiv, Bulgaria, 4002
Pfizer Investigational Site
Sofia, Bulgaria, 1431
Pfizer Investigational Site
Sofia, Bulgaria, 1407
Pfizer Investigational Site
Sofia, Bulgaria, 1113
Pfizer Investigational Site
Sofia, Bulgaria, 1527
Pfizer Investigational Site
Sofia, Bulgaria, 1202
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6L 5X8
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 65691
Pfizer Investigational Site
Plzen - Lochotin, Czech Republic, 304 60
France
Pfizer Investigational Site
Bordeaux, France, 33076
Pfizer Investigational Site
Paris Cedex 13, France, 75651
Germany
Pfizer Investigational Site
Altenburg, Germany, 04600
Pfizer Investigational Site
Essen, Germany, 45122
Pfizer Investigational Site
Leipzig, Germany, 04103
Pfizer Investigational Site
Muenchen, Germany, 81675
Pfizer Investigational Site
Muenster, Germany, 48149
Pfizer Investigational Site
Regensburg, Germany, 93053
Hungary
Pfizer Investigational Site
Balassagyarmat, Hungary, 2660
Pfizer Investigational Site
Budapest, Hungary, 1145
Pfizer Investigational Site
Budapest, Hungary, 1083
Pfizer Investigational Site
Budapest, Hungary, 1134
Pfizer Investigational Site
Budapest, Hungary, 1076
Pfizer Investigational Site
Gyor, Hungary, 9024
India
Pfizer Investigational Site
Pune, Maharashtra, India, 411011
Pfizer Investigational Site
New Delhi, India, 110017
Korea, Republic of
Pfizer Investigational Site
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Pfizer Investigational Site
Anyang-si, Gyonggi-do, Korea, Republic of, 431-070
Pfizer Investigational Site
Gwangju, Korea, Republic of, 501-757
Pfizer Investigational Site
Incheon, Korea, Republic of, 400-711
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Taiwan
Pfizer Investigational Site
Kaohsiung, Taiwan, 833
Pfizer Investigational Site
Taichung, Taiwan, 404
Pfizer Investigational Site
Taipei, Taiwan, 100
Pfizer Investigational Site
Taoyuan County, Taiwan, 333
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: 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:
Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014