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

September 22, 2010
January 30, 2014
December 2010
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Safety and tolerability assessed by an Independent Data and Safety Monitoring Board (DSMB) using data, including 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 ]
Complete list of historical versions of study NCT01208233 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke
A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
  • Drug: PF-03049423
    1 mg of PF-03049423 daily for 90 days
  • Drug: PF-03049423
    3 mg of PF-03049423 daily for 90 days
  • Drug: PF-03049423
    6 mg of PF-03049423 daily for 90 days
  • Other: Placebo
    Placebo of PF-03049423 daily for 90 days
  • Experimental: 1 mg PF-03049423
    Intervention: Drug: PF-03049423
  • Experimental: 3 mg of PF-03049423
    Intervention: Drug: PF-03049423
  • Experimental: 6 mg of PF-03049423
    Intervention: Drug: PF-03049423
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
181
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   Bulgaria,   Canada,   Czech Republic,   France,   Taiwan,   Hungary,   India,   Korea, Republic of
 
NCT01208233
A9541004
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP