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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: PF-03049423; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01208233

2010-021414-32 (EudraCT Number)

A9541004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

181 participants in 4 patient groups, including a placebo group

1 mg PF-03049423

Experimental group

Treatment:

Drug: PF-03049423

Drug: PF-03049423

Drug: PF-03049423

3 mg of PF-03049423

Experimental group

Treatment:

Drug: PF-03049423

Drug: PF-03049423

Drug: PF-03049423

6 mg of PF-03049423

Experimental group

Treatment:

Drug: PF-03049423

Drug: PF-03049423

Drug: PF-03049423

Placebo

Placebo Comparator group

Treatment:

Other: Placebo