Conditions: Ischemic Stroke
Keywords: Phase 2 Ischemic stroke Safety and efficacy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 181
Healthy volunteers: no

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.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: PF-03049423 intervention 2: PF-03049423 intervention 3: PF-03049423 intervention 4: Placebo
Intervention descriptions: intervention 1: 1 mg of PF-03049423 daily for 90 days intervention 2: 3 mg of PF-03049423 daily for 90 days intervention 3: 6 mg of PF-03049423 daily for 90 days intervention 4: Placebo of PF-03049423 daily for 90 days

Protocol document: