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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Spain Rehabilitation Center
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ischemic Stroke
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any other severe acute or chronic medical or psychiatric condition besides the stroke.

- Women of child bearing potential.

- Uncontrolled hypertension.

NCT01208233
Pfizer
Terminated
Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke

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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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Di Cesare F, Mancuso J, Woodward P, Bednar MM, Loudon PT; A9541004 Stroke Study Group. Phosphodiesterase-5 Inhibitor PF-03049423 Effect on Stroke Recovery: A Double-Blind, Placebo-Controlled Randomized Clinical Trial. J Stroke Cerebrovasc Dis. 2016 Mar;25(3):642-9. doi: 10.1016/j.jstrokecerebrovasdis.2015.11.026. Epub 2015 Dec 28.


*   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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Hungary,   India,   Korea, Republic of,   Taiwan,   United States
Mexico
 
NCT01208233
A9541004
2010-021414-32 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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