Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke
NCT01208233
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- 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.
- Any other severe acute or chronic medical or psychiatric condition besides the stroke.
- Women of child bearing potential.
- Uncontrolled hypertension.
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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 181 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |