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

A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke - Not Applicable

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/05/002702

Enrollment

240

Registered

2012-05-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Ischemic Stroke

Interventions

Intervention1: Experimental: 1 mg PF-03049423: 1 mg of PF-03049423 tablets , oral daily dose for 90 days Intervention2: Experimental: 3 mg of PF-03049423: 3 mg of PF-03049423 tablets , oral daily dos

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of ischemic stroke with an onset within 72 hours prior to start of study agent administration, male or female. 2. Supratentorial ischemic stroke involving the cortex documented by neurological exam and confirmed by MRI. 3. Stroke involving upper extremity. 4. Subjects who received thrombolytic therapy may be enrolled and the use of antiplatelet is acceptable.

Exclusion criteria

Exclusion criteria: 1. Any other severe acute or chronic medical or psychiatric condition besides the stroke. 2. Women of child bearing potential. 3. Uncontrolled hypertension.

Design outcomes

Primary

Measure	Time frame
â?¢ Proportion of subjects with Modified Rankin Scale (mRS) less than or equal to 2Timepoint: day 90	—

Secondary

Measure	Time frame
1. Plasma concentrations of PF-03049423Timepoint: Day 90;2. Box and Blocks, Hand Grip Strength TestTimepoint: Day 90;3. Proportion of subjects with: mRS (0-1), NIHSS (0-1), NIHSS, BI, BI greater or equal to 95 and BI equal to 100Timepoint: day 90;4. Domains of Interest: RBANS Coding Sub Test, RBANS Naming Sub Test, Line Cancellation, Recognition Memory TestTimepoint: Day 90;5. Gait VelocityTimepoint: Day 90	—

Measure

Time frame

1. Plasma concentrations of PF-03049423Timepoint: Day 90;2. Box and Blocks, Hand Grip Strength TestTimepoint: Day 90;3. Proportion of subjects with: mRS (0-1), NIHSS (0-1), NIHSS, BI, BI greater or equal to 95 and BI equal to 100Timepoint: day 90;4. Domains of Interest: RBANS Coding Sub Test, RBANS Naming Sub Test, Line Cancellation, Recognition Memory TestTimepoint: Day 90;5. Gait VelocityTimepoint: Day 90

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Countries

Bulgaria, Canada, Czech Republic, France, Germany, Hungary, India, Mexico, Republic of Korea, Taiwan, United States of America

Contacts

Public ContactSwapnali Raut

Representing Pfizer Limited

Swapnali.raut@pfizer.com91-9821415224

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026