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

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.

Timeline

Start

2010-12

Primary completion

2013-12

Completion

2013-12

Outcome

Missed primary endpoint

Stopped: “See termination reason in detailed description.”

paper The primary efficacy analysis using logistic regression showed no statistically significant difference between PF-03049423 6 mg and placebo (responder rate of 42.6% and 46.2%, respectively). PMID 26738812 ↗

registry Cohort 3: PF-03049423 6 mg vs Cohort 3: Placebo; p = 0.4962 NCT01208233 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-03049423	Small molecule	1 mg	Oral
Subject	PF-03049423	Small molecule	3 mg	Oral
Subject	PF-03049423	Small molecule	6 mg	Oral

Indications