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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01208233
First received: September 22, 2010
Last updated: January 22, 2016
Last verified: January 2016
Results First Received: February 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Interventions: Drug: PF-03049423
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 181 participants were assigned to study treatment, 178 of which received study treatment.

Reporting Groups
  Description
Cohort 1: PF-03049423 1 mg Participants received PF-03049423 1 mg once daily for 90 days.
Cohort 1: Placebo Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
Cohort 2: PF-03049423 3 mg Participants received PF-03049423 3 mg once daily for 90 days.
Cohort 2: Placebo Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
Cohort 3: PF-03049423 6 mg Participants received PF-03049423 6 mg once daily for 90 days.
Cohort 3: Placebo Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.

Participant Flow:   Overall Study
    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  
Adverse Event                 0                 1                 2                 0                 3                 5  
Death                 0                 0                 0                 0                 3                 5  
Did not meet entrance criteria                 2                 1                 1                 0                 1                 0  
Medication error without adverse event                 0                 0                 0                 0                 0                 1  
Study terminated by sponsor                 0                 0                 0                 0                 10                 7  
Protocol Violation                 0                 0                 0                 0                 3                 0  
Unspecified                 2                 1                 0                 0                 0                 1  
Withdrawal by Subject                 1                 0                 1                 1                 4                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) consisted of all randomized participants who took any study medication (active or placebo).

Reporting Groups
  Description
Cohort 1: PF-03049423 1 mg Participants received PF-03049423 1 mg once daily for 90 days.
Cohort 1: Placebo Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
Cohort 2: PF-03049423 3 mg Participants received PF-03049423 3 mg once daily for 90 days.
Cohort 2: Placebo Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
Cohort 3: PF-03049423 6 mg Participants received PF-03049423 6 mg once daily for 90 days.
Cohort 3: Placebo Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
Total Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  11     9     11     10     70     67     178  
Age  
[units: years]
Mean (Standard Deviation)
  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)  
Gender  
[units: Participants]
             
Female     4     2     7     3     28     26     70  
Male     7     7     4     7     42     41     108  



  Outcome Measures
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1.  Primary:   Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2)   [ Time Frame: Day 1 (Baseline) up to Day 90 ]

2.  Primary:   Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2)   [ Time Frame: Day 1 (Baseline) up to follow-up (28 days after Day 90) ]

3.  Primary:   Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2)   [ Time Frame: Day 1 (Baseline) to Day 90 ]

4.  Primary:   Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2)   [ Time Frame: Day 1 (Baseline) up to Day 90 ]

5.  Primary:   Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2)   [ Time Frame: Day 1 (Baseline) up to Day 90 ]

6.  Primary:   Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2)   [ Time Frame: Day 7 (Baseline) up to follow up (28 days after Day 90) ]

7.  Primary:   Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2)   [ Time Frame: Day 90 ]

8.  Secondary:   Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic Hand (Part 2)   [ Time Frame: Day 1 (Baseline), Day 90 ]

9.  Secondary:   Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)   [ Time Frame: Day 1 (Baseline), Day 90 ]

10.  Secondary:   Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic and Non-paretic Hands (Part 2)   [ Time Frame: Day 1 (Baseline), Day 90 ]

11.  Secondary:   Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)   [ Time Frame: Day 1 (Baseline), Day 90 ]

12.  Secondary:   Percentage of Participants With mRS (0-1) at Day 90 (Part 2)   [ Time Frame: Day 90 ]

13.  Secondary:   Percentage of Participants With National Institutes of Health Stroke Scale (NIHSS) (0-1) at Day 90 (Part 2)   [ Time Frame: Day 90 ]

14.  Secondary:   Change From Baseline in NIHSS at Day 90 (Part 2)   [ Time Frame: Day 1 (Baseline), Day 90 ]

15.  Secondary:   Percentage of Participants With Barthel Index (BI) >= 95 and BI =100 at Day 90 (Part 2)   [ Time Frame: Day 90 ]

16.  Secondary:   BI at Day 90 (Part 2)   [ Time Frame: Day 90 ]

17.  Secondary:   Domains of Interest: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding Sub Test at Day 90 (Part 2)   [ Time Frame: Day 1 (Baseline), Day 90 ]

18.  Secondary:   Domains of Interest: Change From Baseline in RBANS Naming Sub Test at Day 90 (Part 2)   [ Time Frame: Day 1 (Baseline), Day 90 ]

19.  Secondary:   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)   [ Time Frame: Day 1 (Baseline), Day 90 ]

20.  Secondary:   Domains of Interest: Change From Baseline in Line Cancellation Test at Day 90 [(L-R)/(L+R)] (Part 2)   [ Time Frame: Day 1 (Baseline), Day 90 ]

21.  Secondary:   Domains of Interest: Change From Baseline in Recognition Memory Test at Day 90 (Part 2)   [ Time Frame: Day 1 (Baseline), Day 90 ]

22.  Secondary:   Gait Velocity Test at Day 90 (Part 2)   [ Time Frame: Day 90 ]

23.  Secondary:   Plasma Concentrations of PF-03049423 (Part 1 and 2)   [ Time Frame: Days 1, 2, 7, 14, 30, 60 and 90 ]

24.  Secondary:   Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Non-paretic Hand (Part 2)   [ Time Frame: Day 1 (Baseline), Day 90 ]

25.  Other Pre-specified:   All-cause Mortality (Part 2)   [ Time Frame: The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product. ]

26.  Other Pre-specified:   Mortality Directly Related to Stroke (Part 2)   [ Time Frame: The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product. ]

27.  Other Pre-specified:   Number of Participants With Neuro-worsening (Part 2)   [ Time Frame: Day 1 (Baseline) up to Day 90 ]

28.  Other Pre-specified:   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 ]

29.  Other Pre-specified:   Treatment-emergent Adverse Events (AEs) Resulting in Discontinuation of Study Drug (Part 2)   [ Time Frame: Day 1 (Baseline) up to follow-up (28 days after Day 90) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated prematurely due to demonstrated futility at interim analysis. The final results are consistent with interim results.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01208233     History of Changes
Other Study ID Numbers: A9541004
2010-021414-32 ( EudraCT Number )
Study First Received: September 22, 2010
Results First Received: February 19, 2015
Last Updated: January 22, 2016
Health Authority: United States: Food and Drug Administration