A Phase 2 interventional study of PF-03049423 and PF-03049423 in Ischemic Stroke, sponsored by Pfizer. Terminated at 70 sites in 10 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
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.
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.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's enrollment of 181 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
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Exclusion Criteria:
Drug: PF-03049423
Drug: PF-03049423
Drug: PF-03049423
Other: Placebo
1 mg of PF-03049423 daily for 90 days
3 mg of PF-03049423 daily for 90 days
6 mg of PF-03049423 daily for 90 days
Placebo of PF-03049423 daily for 90 days
Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2)
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. \*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.
Time frame: Day 1 (Baseline) up to Day 90
Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2)
Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic BP (SBP) greater than or equal to (\>=) 30 or 50 millimeters of mercury (mm Hg) change from grand baseline in same posture, systolic less than (\<) 90 mm Hg; diastolic BP (DBP) \>=20 mm Hg change from grand baseline in same posture, diastolic \<50 mm Hg; 2), pulse rate (supine, sitting and standing): \<40 or greater than (\>) 120 beats per minute (bpm); Standing: \<40 or \>140 bpm. \*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.
Time frame: Day 1 (Baseline) up to follow-up (28 days after Day 90)
Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2)
ECG criteria of potential clinical concern were 1), PR interval: \>=300 milliseconds (msec); \>=25% increase when baseline \>200 msec; or increase \>=50% when baseline \<=200 msec; 2), QRS interval: \>=140 msec; \>=50% increase from baseline; 3), QT interval: \>=500 msec, QTc interval using Fridericia's formula (QTcF interval): absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>=500 msec; absolute change 30 - \<60, \>=60 msec. \*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.
Time frame: Day 1 (Baseline) to Day 90
Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2)
The complete physical examination included examination of the skin, eyes, ears, throat, neck, cardiac, respiratory, gastrointestinal, and musculoskeletal systems. The limited physical examination included examination of the cardiac, respiratory, gastrointestinal, and musculoskeletal systems. \*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.
Time frame: Day 1 (Baseline) up to Day 90
Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2)
The complete neurological examination included an assessment of the motor, sensory, cranial nerves, reflexes, mental status and associated motor functions. The limited neurological exam could examine the same categories of neurologic assessments as the full examination, but would differ by the depth in the examination. The examination was required to be done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the Investigator, but had to always include an assessment of motor, vision and hearing. \*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.
Time frame: Day 1 (Baseline) up to Day 90
Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2)
Data were mapped to Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed if participant experienced: completed suicide (Code 1), suicide attempt (Code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for any of above mentioned categories was assessed. \*This was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for it were not reported separately, Part 1 and 2 data were reported together.
Time frame: Day 7 (Baseline) up to follow up (28 days after Day 90)
Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2)
The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).
Time frame: Day 90
Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic Hand (Part 2)
The B\&B test is a measure of manual dexterity. The B\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.
Time frame: Day 1 (Baseline), Day 90
Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)
The B\&B test is a measure of manual dexterity. The B\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.
Time frame: Day 1 (Baseline), Day 90
Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic and Non-paretic Hands (Part 2)
The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.
Time frame: Day 1 (Baseline), Day 90
Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)
The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.
Time frame: Day 1 (Baseline), Day 90
Percentage of Participants With mRS (0-1) at Day 90 (Part 2)
The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).
Time frame: Day 90
Percentage of Participants With National Institutes of Health Stroke Scale (NIHSS) (0-1) at Day 90 (Part 2)
The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.
Time frame: Day 90
Change From Baseline in NIHSS at Day 90 (Part 2)
The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.
Time frame: Day 1 (Baseline), Day 90
Percentage of Participants With Barthel Index (BI) >= 95 and BI =100 at Day 90 (Part 2)
The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant's ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.
Time frame: Day 90
BI at Day 90 (Part 2)
The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant's ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.
Time frame: Day 90
Domains of Interest: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding Sub Test at Day 90 (Part 2)
The test uses a reference key, the participant had 90 seconds to pair specific numbers with given geometric figures. Responses could be written or oral. The performance measure for this task was the total number of correct responses.
Time frame: Day 1 (Baseline), Day 90
Domains of Interest: Change From Baseline in RBANS Naming Sub Test at Day 90 (Part 2)
This test requires the participant to name 10 objects drawn in ink. The tester asked the participant to identify the picture. The participant had 20 seconds to respond to each picture presented. The performance measure was the number of objects named correctly.
Time frame: Day 1 (Baseline), Day 90
Domains of Interest: Change From Baseline in Line Cancellation Test [(L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%)] at Day 90 (Part 2)
The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.
Time frame: Day 1 (Baseline), Day 90
Domains of Interest: Change From Baseline in Line Cancellation Test at Day 90 [(L-R)/(L+R)] (Part 2)
The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.
Time frame: Day 1 (Baseline), Day 90
Domains of Interest: Change From Baseline in Recognition Memory Test at Day 90 (Part 2)
This test assesses the ability to recognize pictures of objects. The participant was presented a series of pictures, a subset of which were the objects presented in the RBANS Naming Sub Test. After each picture was presented, the participant indicated either manually (ie, affirmative head nod) or verbally whether the picture was seen previously. The participant was given 5 seconds per picture to respond. The performance measure for this task was the total number of pictures correctly identified.
Time frame: Day 1 (Baseline), Day 90
Gait Velocity Test at Day 90 (Part 2)
The 10-meter walk test requires a 20 meter straight path, with 5 meters for acceleration, 10 meters for steady state walking, and 5 meters for deceleration. Markers were placed at the 5 and 15 meter positions along the path. The participant began to walk "at a comfortable pace" at 1 end of the path, and continued walking until he/she reached the other end. The rater used a stopwatch to determine how much time it took for the participant to traverse the 10 meter center of the path, starting the stopwatch as soon as the participant's limb crossed the first marker and stopping the stopwatch as soon as the participant's limb crossed the second marker.
Time frame: Day 90
Plasma Concentrations of PF-03049423 (Part 1 and 2)
Time frame: Days 1, 2, 7, 14, 30, 60 and 90
Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Non-paretic Hand (Part 2)
The B\&B test is a measure of manual dexterity. The B\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.
Time frame: Day 1 (Baseline), Day 90
All-cause Mortality (Part 2)
Deaths regardless causality were reported.
Time frame: The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.
Mortality Directly Related to Stroke (Part 2)
Deaths caused by stroke were reported.
Time frame: The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.
Number of Participants With Neuro-worsening (Part 2)
NIHSS change of 4 points or greater.
Time frame: Day 1 (Baseline) up to Day 90
Number of Participants With SBP <100 mm Hg or SBP Decline >=30 mm Hg From Immediate Pre-dose Measurement, With or Without Neuro-worsening (Defined as an NIHSS Increase of 4 Points or Greater) Within 2 Hours Post-dose (Part 2)
Time frame: Day 1 (Baseline) up to Day 14
Treatment-emergent Adverse Events (AEs) Resulting in Discontinuation of Study Drug (Part 2)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Day 1 (Baseline) up to follow-up (28 days after Day 90)
| Milestone | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| Started | 11 | 9 | 11 | 10 | 70 | 67 |
| Completed | 6 | 6 | 7 | 9 | 46 | 46 |
| Not completed | 5 | 3 | 4 | 1 | 24 | 21 |
| Withdrew: Adverse event | 0 | 1 | 2 | 0 | 3 | 5 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 3 | 5 |
| Withdrew: Did not meet entrance criteria | 2 | 1 | 1 | 0 | 1 | 0 |
| Withdrew: Medication error without adverse event | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 10 | 7 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 3 | 0 |
| Withdrew: Other | 2 | 1 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 | 1 | 4 | 2 |
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. \*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.
| participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2) | 8 | 8 | 10 | 9 | 64 | 56 |
Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic BP (SBP) greater than or equal to (\>=) 30 or 50 millimeters of mercury (mm Hg) change from grand baseline in same posture, systolic less than (\<) 90 mm Hg; diastolic BP (DBP) \>=20 mm Hg change from grand baseline in same posture, diastolic \<50 mm Hg; 2), pulse rate (supine, sitting and standing): \<40 or greater than (\>) 120 beats per minute (bpm); Standing: \<40 or \>140 bpm. \*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.
| participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| Supine SBP <90 mm Hg, n=11,9,11,10,70,67 | 0 | 1 | 1 | 0 | 3 | 0 |
| Sitting SBP <90 mm Hg, n=10,8,9,5,55,59 | 0 | 1 | 1 | 0 | 2 | 2 |
| Standing SBP <90 mm Hg, n=7,7,9,8,49,48 | 0 | 0 | 0 | 0 | 1 | 1 |
| Supine DBP <50 mm Hg, n=11,9,11,10,70,67 | 0 | 0 | 2 | 1 | 6 | 4 |
| Sitting DBP <50 mm Hg, n=10,8,9,5,55,59 | 0 | 0 | 0 | 0 | 3 | 1 |
| Standing DBP <50 mm Hg, n=7,7,9,8,49,48 | 0 | 0 | 0 | 1 | 2 | 3 |
| Supine pulse rate <40 bpm, n=11,9,11,10,70,67 | 0 | 0 | 0 | 0 | 1 | 0 |
| Supine pulse rate >120 bpm, n=11,9,11,10,70,67 | 0 | 0 | 1 | 0 | 5 | 7 |
| Increase:supine SBP >=30 mm Hg, n=11,9,11,10,70,67 | 2 | 3 | 5 | 3 | 13 | 17 |
| Increase: sitting SBP >=30 mm Hg, n=9,6,9,4,48,44 | 0 | 2 | 2 | 0 | 10 | 9 |
| Increase: standing SBP >=30 mm Hg, n=2,3,3,6,19,22 | 0 | 0 | 0 | 2 | 2 | 1 |
| Increase:supine DBP >=20 mm Hg, n=11,9,11,10,70,67 | 4 | 2 | 5 | 2 | 16 | 22 |
| Increase: sitting DBP >=20 mm Hg, n=9,6,9,4,48,44 | 3 | 1 | 2 | 2 | 9 | 12 |
| Increase: standing DBP >=20 mm Hg, n=2,3,3,6,19,22 | 0 | 0 | 0 | 2 | 3 | 3 |
| Decrease:supine SBP >=30 mm Hg, n=11,9,11,10,70,67 | 7 | 6 | 5 | 4 | 37 | 37 |
| Decrease: sitting SBP >=30 mm Hg, n=9,6,9,4,48,44 | 3 | 4 | 6 | 2 | 26 | 18 |
| Decrease: standing SBP >=30 mm Hg, n=2,3,3,6,19,22 | 2 | 2 | 0 | 2 | 10 | 11 |
| Decrease:supine DBP >=20 mm Hg, n=11,9,11,10,70,67 | 8 | 6 | 6 | 3 | 32 | 26 |
| Decrease: sitting DBP >=20 mm Hg, n=9,6,9,4,48,44 | 1 | 4 | 5 | 1 | 23 | 14 |
| Decrease: standing DBP >=20 mm Hg, n=2,3,3,6,19,22 | 2 | 2 | 1 | 2 | 6 | 11 |
| Decrease:supine SBP >=50 mm Hg, n=11,9,11,10,70,67 | 2 | 0 | 1 | 2 | 10 | 9 |
| Decrease: sitting SBP >=50 mm Hg, n=9,6,9,4,48,44 | 2 | 1 | 3 | 0 | 7 | 6 |
| Decrease: standing SBP >=50 mm Hg, n=2,3,3,6,19,22 | 1 | 0 | 0 | 0 | 1 | 2 |
| Sitting pulse rate <40 bpm, n=1,0,2,0,3,2 | 0 | NA | 0 | NA | 0 | 0 |
| Standing pulse rate <40 bpm, n=0,0,0,2,1,0 | NA | NA | NA | 0 | 0 | NA |
| Sitting pulse rate >120 bpm, n=1,0,2,0,3,2 | 0 | NA | 0 | NA | 0 | 0 |
| Standing pulse rate >140 bpm, n=0,0,0,2,1,0 | NA | NA | NA | 0 | 0 | NA |
ECG criteria of potential clinical concern were 1), PR interval: \>=300 milliseconds (msec); \>=25% increase when baseline \>200 msec; or increase \>=50% when baseline \<=200 msec; 2), QRS interval: \>=140 msec; \>=50% increase from baseline; 3), QT interval: \>=500 msec, QTc interval using Fridericia's formula (QTcF interval): absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>=500 msec; absolute change 30 - \<60, \>=60 msec. \*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.
| participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| PR interval >=300 msec, n=11,9,11,10,70,67 | 0 | 0 | 0 | 0 | 0 | 0 |
| QRS interval >=140 msec, n=11,9,11,10,70,67 | 1 | 0 | 1 | 1 | 0 | 1 |
| QT interval >=500 msec, n=11,9,11,10,70,67 | 0 | 0 | 0 | 0 | 4 | 1 |
| QTcF interval 450-480 msec, n=11,9,11,10,70,67 | 2 | 3 | 4 | 2 | 14 | 14 |
| QTcF interval 480-500 msec, n=11,9,11,10,70,67 | 0 | 1 | 0 | 1 | 4 | 3 |
| QTcF interval >=500 msec, n=11,9,11,10,70,67 | 0 | 0 | 1 | 0 | 0 | 1 |
| PR interval increase >=25%/50%, n=10,7,9,9,52,47 | 0 | 0 | 1 | 0 | 1 | 0 |
| QRS interval increase >=50%, n=10,9,11,10,69,66 | 0 | 0 | 0 | 0 | 0 | 1 |
| QTcF increase 30-60 msec, n=10,9,11,10,69,66 | 2 | 3 | 4 | 2 | 19 | 11 |
| QTcF increase >=60 msec, n=10,9,11,10,69,66 | 0 | 0 | 0 | 1 | 3 | 5 |
The complete physical examination included examination of the skin, eyes, ears, throat, neck, cardiac, respiratory, gastrointestinal, and musculoskeletal systems. The limited physical examination included examination of the cardiac, respiratory, gastrointestinal, and musculoskeletal systems. \*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.
| participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2) | 1 | 1 | 0 | 0 | 2 | 0 |
The complete neurological examination included an assessment of the motor, sensory, cranial nerves, reflexes, mental status and associated motor functions. The limited neurological exam could examine the same categories of neurologic assessments as the full examination, but would differ by the depth in the examination. The examination was required to be done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the Investigator, but had to always include an assessment of motor, vision and hearing. \*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.
| participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2) | 1 | 1 | 0 | 0 | 4 | 0 |
Data were mapped to Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed if participant experienced: completed suicide (Code 1), suicide attempt (Code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for any of above mentioned categories was assessed. \*This was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for it were not reported separately, Part 1 and 2 data were reported together.
| participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| Day 7, n=0, 0, 1, 1, 64, 57 | NA | NA | 0 | 0 | 1 | 2 |
| Day 14, n=0, 0, 1, 1, 59, 53 | NA | NA | 0 | 0 | 1 | 0 |
| Day 30, n=0, 0, 1, 1, 60, 47 | NA | NA | 0 | 0 | 2 | 0 |
| Day 60, n=0, 0, 1, 1, 55, 44 | NA | NA | 0 | 0 | 2 | 0 |
| Day 90, n=0, 0, 1, 1, 61, 53 | NA | NA | 0 | 0 | 1 | 1 |
| Follow-up, n=0, 0, 1, 1, 59, 51 | NA | NA | 0 | 0 | 0 | 0 |
The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).
| percentage of participants | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Last Observation Carried Forward (LOCF), n=68, 65 | 42.6 | 46.2 |
| Observed Cases (OC), n=51, 52 | 47.1 | 50.0 |
The B\&B test is a measure of manual dexterity. The B\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.
| blocks moved per minute | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic Hand (Part 2) | 26.881 ± 3.8667 | 26.741 ± 3.5627 |
The B\&B test is a measure of manual dexterity. The B\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.
| percentage change | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2) | 41.830 ± 7.7810 | 31.041 ± 7.1284 |
The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.
| pounds | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Paretic Hand, n=26, 26 | 20.556 ± 4.1829 | 30.886 ± 3.9964 |
| Non-Paretic Hand, n=46, 41 | 12.546 ± 2.3612 | 12.312 ± 2.5029 |
The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.
| percentage change | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2) | 23.949 ± 5.4499 | 36.761 ± 5.1182 |
The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).
| percentage of participants | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Percentage of Participants With mRS (0-1) at Day 90 (Part 2) | 25.0 | 24.6 |
The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.
| percentage of participants | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Percentage of Participants With National Institutes of Health Stroke Scale (NIHSS) (0-1) at Day 90 (Part 2) | 25.0 | 26.2 |
The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.
| unit on a scale | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Change From Baseline in NIHSS at Day 90 (Part 2) | -6.511 ± 0.5384 | -6.228 ± 0.5655 |
The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant's ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.
| percentage of participants | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| BI >=95 | 47.1 | 40.0 |
| BI=100 | 42.6 | 35.4 |
The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant's ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.
| unit on a scale | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| BI at Day 90 (Part 2) | 79.151 ± 3.6248 | 73.552 ± 3.8471 |
The test uses a reference key, the participant had 90 seconds to pair specific numbers with given geometric figures. Responses could be written or oral. The performance measure for this task was the total number of correct responses.
| correct responses | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Domains of Interest: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding Sub Test at Day 90 (Part 2) | 13.748 ± 1.5321 | 12.686 ± 1.6282 |
This test requires the participant to name 10 objects drawn in ink. The tester asked the participant to identify the picture. The participant had 20 seconds to respond to each picture presented. The performance measure was the number of objects named correctly.
| objects named correctly | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Domains of Interest: Change From Baseline in RBANS Naming Sub Test at Day 90 (Part 2) | 0.989 ± 0.3676 | 1.324 ± 0.3666 |
The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.
| change in percentage of lines crossed | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| (L+R)/28 × 100%, n=39, 35 | 19.459 ± 4.4433 | 16.983 ± 4.4551 |
| (L/14) × 100%, n=39, 35 | 22.824 ± 5.6691 | 18.950 ± 5.6639 |
| (R/14) × 100%, n=39, 35 | 16.481 ± 4.3564 | 15.431 ± 4.3647 |
The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.
| change in ratio | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Domains of Interest: Change From Baseline in Line Cancellation Test at Day 90 [(L-R)/(L+R)] (Part 2) | 0.083 ± 0.0620 | -0.023 ± 0.0625 |
This test assesses the ability to recognize pictures of objects. The participant was presented a series of pictures, a subset of which were the objects presented in the RBANS Naming Sub Test. After each picture was presented, the participant indicated either manually (ie, affirmative head nod) or verbally whether the picture was seen previously. The participant was given 5 seconds per picture to respond. The performance measure for this task was the total number of pictures correctly identified.
| pictures correctly identified | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Domains of Interest: Change From Baseline in Recognition Memory Test at Day 90 (Part 2) | -1.135 ± 0.4743 | 0.144 ± 0.4797 |
The 10-meter walk test requires a 20 meter straight path, with 5 meters for acceleration, 10 meters for steady state walking, and 5 meters for deceleration. Markers were placed at the 5 and 15 meter positions along the path. The participant began to walk "at a comfortable pace" at 1 end of the path, and continued walking until he/she reached the other end. The rater used a stopwatch to determine how much time it took for the participant to traverse the 10 meter center of the path, starting the stopwatch as soon as the participant's limb crossed the first marker and stopping the stopwatch as soon as the participant's limb crossed the second marker.
| meters/second (m/s) | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Gait Velocity Test at Day 90 (Part 2) | 1.064 ± 0.1040 | 0.975 ± 0.1128 |
| nanogram/milliliter (ng/mL) | Cohort 1: PF-03049423 1 mg | Cohort 2: PF-03049423 3 mg | Cohort 3: PF-03049423 6 mg |
|---|---|---|---|
| Day 1 (0 hour predose), n=0, 1, 3 | NA ± NA | 0.05245 ± 0.17397 | 1.420 ± 11.591 |
| Day 1 (1 hour post dose), n=11, 10, 63 | 5.825 ± 4.3514 | 17.50 ± 12.814 | 46.76 ± 36.153 |
| Day 1 (2 hours post dose), n=11, 11, 61 | 7.063 ± 3.2729 | 30.18 ± 11.313 | 58.19 ± 32.837 |
| Day 1 (8 hours post dose), n=11, 11, 68 | 7.361 ± 2.4032 | 25.39 ± 8.6644 | 52.47 ± 23.250 |
| Day 2 (0 hour, predose), n=11, 11, 67 | 4.521 ± 1.5265 | 18.05 ± 4.7834 | 32.07 ± 13.776 |
| Day 7 (0 hour, post dose), n=9, 7, 64 | 8.601 ± 2.9609 | 27.79 ± 7.6945 | 53.08 ± 30.237 |
| Day 7 (1 hour post dose), n=0, 1, 59 | NA ± NA | 51.80 ± NA | 115.9 ± 65.329 |
| Day 7 (2 hours post dose), n=0, 1, 59 | NA ± NA | 58.10 ± NA | 126.3 ± 57.759 |
| Day 7 (6 hours post dose), n=0, 1, 61 | NA ± NA | 51.10 ± NA | 103.8 ± 41.090 |
| Day 14 (0 hour predose), n=10, 8, 59 | 7.805 ± 2.9278 | 31.13 ± 9.8243 | 53.10 ± 28.085 |
| Day 14 (1 hour post dose), n=9, 7, 0 | 16.47 ± 7.1782 | 76.71 ± 32.657 | NA ± NA |
| Day 14 (2 hours post dose), n=9, 6, 0 | 17.06 ± 7.3799 | 70.37 ± 14.795 | NA ± NA |
| Day 14 (6 [cohort 3:4] hours post dose), n=9,7,31 | 17.57 ± 4.1614 | 58.36 ± 11.720 | 118.2 ± 41.967 |
| Day 30 (0 hour predose), n=6, 6, 58 | 5.339 ± 3.5712 | 29.68 ± 11.015 | 50.77 ± 31.473 |
| Day 30 (4 hours post dose), n=2, 5, 25 | 11.55 ± 2.6234 | 57.08 ± 13.990 | 96.27 ± 49.929 |
| Day 60 (0 hour predose), n=6, 6, 53 | 6.360 ± 3.1028 | 24.55 ± 5.8206 | 49.37 ± 33.747 |
| Day 60 (4 hours post dose), n=2, 5, 27 | 13.25 ± 0.7778 | 47.86 ± 7.3296 | 112.1 ± 58.560 |
| Day 90 (0 hour predose), n=5, 6, 45 | 5.252 ± 1.5161 | 29.18 ± 15.909 | 47.02 ± 24.065 |
| Day 90 (4 hours post dose), n=2, 5, 20 | 12.80 ± 0.000 | 49.40 ± 13.962 | 82.69 ± 29.005 |
Deaths regardless causality were reported.
| Number of participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| All-cause Mortality (Part 2) | 0 | 0 | 0 | 0 | 6 | 7 |
Deaths caused by stroke were reported.
| Number of participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| Mortality Directly Related to Stroke (Part 2) | 0 | 0 | 0 | 0 | 3 | 0 |
NIHSS change of 4 points or greater.
| Number of participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| Number of Participants With Neuro-worsening (Part 2) | NA | NA | NA | NA | NA | NA |
| Number of participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| Number of Participants With SBP <100 mm Hg or SBP Decline >=30 mm Hg From Immediate Pre-dose Measurement, With or Without Neuro-worsening (Defined as an NIHSS Increase of 4 Points or Greater) Within 2 Hours Post-dose (Part 2) | NA | NA | NA | NA | NA | NA |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
| Number of participants | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| Treatment-emergent Adverse Events (AEs) Resulting in Discontinuation of Study Drug (Part 2) | 0 | 1 | 2 | 0 | 3 | 5 |
The B\&B test is a measure of manual dexterity. The B\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.
| blocks moved per minute | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|
| Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Non-paretic Hand (Part 2) | 17.797 ± 2.1676 | 18.313 ± 2.2407 |
Collected over From the time the subject had taken at least 1 dose of study treatment through last subject visit. For SAEs, the time began from the subject provided informed consent through 28 calendar days post last administration of investigational product.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: PF-03049423 1 mg | — | 2/11 (18.2%) | 10/11 (90.9%) |
| Cohort 1: Placebo | — | 1/9 (11.1%) | 7/9 (77.8%) |
| Cohort 2: PF-03049423 3 mg | — | 3/11 (27.3%) | 7/11 (63.6%) |
| Cohort 2: Placebo | — | 1/10 (10%) | 9/10 (90%) |
| Cohort 3: PF-03049423 6 mg | — | 15/70 (21.4%) | 50/70 (71.4%) |
| Cohort 3: Placebo | — | 18/67 (26.9%) | 47/67 (70.1%) |
| Event | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| CholangitisHepatobiliary disorders | 0/11 | 1/9 | 0/11 | 0/10 | 0/70 | 0/67 |
| Ileus paralyticGastrointestinal disorders | 0/11 | 0/9 | 0/11 | 1/10 | 0/70 | 0/67 |
| Ischaemic strokeNervous system disorders | 0/11 | 0/9 | 0/11 | 1/10 | 1/70 | 0/67 |
| AnaemiaBlood and lymphatic system disorders | 0/11 | 0/9 | 1/11 | 0/10 | 0/70 | 0/67 |
| PneumoniaInfections and infestations | 1/11 | 0/9 | 0/11 | 0/10 | 1/70 | 0/67 |
| ConcussionInjury, poisoning and procedural complications | 0/11 | 0/9 | 1/11 | 0/10 | 0/70 | 0/67 |
| Radius fractureInjury, poisoning and procedural complications | 0/11 | 0/9 | 1/11 | 0/10 | 0/70 | 0/67 |
| Hepatic enzyme increasedInvestigations | 1/11 | 0/9 | 0/11 | 0/10 | 0/70 | 0/67 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/11 | 0/9 | 0/11 | 0/10 | 3/70 | 0/67 |
| Acute myocardial infarctionCardiac disorders | 0/11 | 0/9 | 0/11 | 0/10 | 0/70 | 2/67 |
| Event | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo |
|---|---|---|---|---|---|---|
| HypertensionVascular disorders | 1/11 | 4/9 | 0/11 | 1/10 | 3/70 | 2/67 |
| HeadacheNervous system disorders | 4/11 | 3/9 | 1/11 | 0/10 | 5/70 | 7/67 |
| Sleep disorderPsychiatric disorders | 3/11 | 0/9 | 0/11 | 0/10 | 4/70 | 1/67 |
| Atrial septal defectCongenital, familial and genetic disorders | 0/11 | 2/9 | 0/11 | 0/10 | 1/70 | 2/67 |
| NauseaGastrointestinal disorders | 1/11 | 2/9 | 1/11 | 0/10 | 2/70 | 4/67 |
| InsomniaPsychiatric disorders | 0/11 | 2/9 | 0/11 | 0/10 | 7/70 | 2/67 |
| ConstipationGastrointestinal disorders | 0/11 | 1/9 | 1/11 | 1/10 | 8/70 | 14/67 |
| Hepatic enzyme increasedInvestigations | 0/11 | 0/9 | 0/11 | 2/10 | 0/70 | 0/67 |
| VomitingGastrointestinal disorders | 0/11 | 0/9 | 2/11 | 0/10 | 1/70 | 4/67 |
| Oedema peripheralGeneral disorders | 0/11 | 0/9 | 2/11 | 0/10 | 3/70 | 3/67 |
The Full Analysis Set (FAS) consisted of all randomized participants who took any study medication (active or placebo).
| Age, Continuous(years) | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Mean | 62.3 ± 14.3 | 64.7 ± 6.0 | 69.8 ± 8.3 | 65.8 ± 13.4 | 64.2 ± 13.1 | 65.6 ± 11.3 | 65.1 ± 12.0 |
| Sex: Female, Male(Participants) | Cohort 1: PF-03049423 1 mg | Cohort 1: Placebo | Cohort 2: PF-03049423 3 mg | Cohort 2: Placebo | Cohort 3: PF-03049423 6 mg | Cohort 3: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Female | 4 | 2 | 7 | 3 | 28 | 26 | 70 |
| Male | 7 | 7 | 4 | 7 | 42 | 41 | 108 |
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