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

NCT01208233

Last updated date
Study Location
Spain Rehabilitation Center
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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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.

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Ischemic StrokeStudy Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke
NCT01208233
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Deerfield Beach, Florida
  5. Fort Lauderdale, Florida
  6. Port Charlotte, Florida
  7. Port Charlotte, Florida
  8. Columbus, Georgia
  9. Columbus, Georgia
  10. Columbus, Georgia
  11. Columbus, Georgia
  12. Columbus, Georgia
  13. Fort Wayne, Indiana
  14. Fort Wayne, Indiana
  15. Fort Wayne, Indiana
  16. Fort Wayne, Indiana
  17. Huntington, Indiana
  18. Boston, Massachusetts
  19. Boston, Massachusetts
  20. Detroit, Michigan
  21. St. Louis, Missouri
  22. St. Louis, Missouri
  23. Chapel Hill, North Carolina
  24. Chapel Hill, North Carolina
  25. Oklahoma City, Oklahoma
  26. Oklahoma City, Oklahoma
  27. Oklahoma City, Oklahoma
  28. Oklahoma City, Oklahoma
  29. Hershey, Pennsylvania
  30. Hummelstown, Pennsylvania
  31. Houston, Texas
  32. Houston, Texas
  33. Pleven,
  34. Plovdiv,
  35. Sofia,
  36. Sofia,
  37. Sofia,
  38. Sofia,
  39. Sofia,
  40. Edmonton, Alberta
  41. Brno,
  42. Plzen - Lochotin,
  43. Bordeaux,
  44. Paris Cedex 13,
  45. Altenburg,
  46. Essen,
  47. Leipzig,
  48. Muenchen,
  49. Muenster,
  50. Regensburg,
  51. Balassagyarmat,
  52. Budapest,
  53. Budapest,
  54. Budapest,
  55. Budapest,
  56. Gyor,
  57. Pune, Maharashtra
  58. New Delhi,
  59. Seongnam-si, Gyeonggi-do
  60. Anyang-si, Gyonggi-do
  61. Gwangju,
  62. Incheon,
  63. Seoul,
  64. Seoul,
  65. Seoul,
  66. Seoul,
  67. Kaohsiung,
  68. Taichung,
  69. Taipei,
  70. Taoyuan County,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke
Official Title  ICMJE A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of Pf-03049423 In Subjects With Ischemic Stroke
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 30, 2014)
181
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2010)
240
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Hungary,   India,   Korea, Republic of,   Taiwan,   United States
Removed Location Countries Mexico
 
Administrative Information
NCT Number  ICMJE NCT01208233
Other Study ID Numbers  ICMJE A9541004
2010-021414-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2016

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