Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke
This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01208233
First received: September 22, 2010
Last updated: June 13, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Stroke |
Drug: PF-03049423 Other: Placebo |
Phase 2 |
| 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 |
| Official Title: | A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Safety and tolerability assessed by an Independent Data and Safety Monitoring Board (DSMB) using data, including SAEs, AEs , vital signs, brain MRI, ECG, physical (including neurological) examination, NIHSS scores, laboratory tests. [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
- Proportion of subjects with Modified Rankin Scale (mRS) less than or equal to 2 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Plasma concentrations of PF-03049423 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Box and Blocks, Hand Grip Strength Test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Proportion of subjects with: mRS (0-1), NIHSS (0-1), NIHSS, BI, BI greater or equal to 95 and BI =100 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Domains of Interest: RBANS Coding Sub Test, RBANS Naming Sub Test, Line Cancellation, Recognition Memory Test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Gait Velocity [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 mg PF-03049423 |
Drug: PF-03049423
1 mg of PF-03049423 daily for 90 days
|
| Experimental: 3 mg of PF-03049423 |
Drug: PF-03049423
3 mg of PF-03049423 daily for 90 days
|
| Experimental: 6 mg of PF-03049423 |
Drug: PF-03049423
6 mg of PF-03049423 daily for 90 days
|
| Placebo Comparator: Placebo |
Other: Placebo
Placebo of PF-03049423 daily for 90 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208233
Hide Study Locations
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Hide Study LocationsLocations
| United States, Alabama | |
| Pfizer Investigational Site | Terminated |
| Birmingham, Alabama, United States, 35294-3280 | |
| Pfizer Investigational Site | Terminated |
| Birmingham, Alabama, United States, 35233 | |
| United States, Florida | |
| Pfizer Investigational Site | Recruiting |
| Deerfield Beach, Florida, United States, 33064 | |
| Pfizer Investigational Site | Recruiting |
| Fort Lauderdale, Florida, United States, 33308 | |
| Pfizer Investigational Site | Terminated |
| Port Charlotte, Florida, United States, 33952 | |
| United States, Georgia | |
| Pfizer Investigational Site | Terminated |
| Columbus, Georgia, United States, 31901 | |
| Pfizer Investigational Site | Terminated |
| Columbus, Georgia, United States, 31909 | |
| Pfizer Investigational Site | Terminated |
| Columbus, Georgia, United States, 31907 | |
| Pfizer Investigational Site | Terminated |
| Columbus, Georgia, United States, 31904 | |
| United States, Indiana | |
| Pfizer Investigational Site | Recruiting |
| Fort Wayne, Indiana, United States, 46805 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Pfizer Investigational Site | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Pfizer Investigational Site | Recruiting |
| Golden Valley, Minnesota, United States, 55422 | |
| Pfizer Investigational Site | Recruiting |
| Robbinsdale, Minnesota, United States, 55422 | |
| United States, Missouri | |
| Pfizer Investigational Site | Active, not recruiting |
| St. Louis, Missouri, United States, 63110 | |
| United States, North Carolina | |
| Pfizer Investigational Site | Not yet recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Pfizer Investigational Site | Not yet recruiting |
| Chapel Hill, North Carolina, United States, 27599-7025 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Pfizer Investigational Site | Recruiting |
| Hummelstown, Pennsylvania, United States, 17036 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | Recruiting |
| Pawtucket, Rhode Island, United States, 02860 | |
| Pfizer Investigational Site | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| United States, Texas | |
| Pfizer Investigational Site | Recruiting |
| Houston, Texas, United States, 77030 | |
| Bulgaria | |
| Pfizer Investigational Site | Recruiting |
| Pleven, Bulgaria, 5800 | |
| Pfizer Investigational Site | Not yet recruiting |
| Plovdiv, Bulgaria, 4002 | |
| Pfizer Investigational Site | Recruiting |
| Sofia, Bulgaria, 1431 | |
| Pfizer Investigational Site | Recruiting |
| Sofia, Bulgaria, 1113 | |
| Pfizer Investigational Site | Recruiting |
| Sofia, Bulgaria, 1407 | |
| Pfizer Investigational Site | Terminated |
| Sofia, Bulgaria, 1202 | |
| Pfizer Investigational Site | Recruiting |
| Sofia, Bulgaria, 1527 | |
| Canada, Alberta | |
| Pfizer Investigational Site | Terminated |
| Edmonton, Alberta, Canada, T6L 5X8 | |
| Czech Republic | |
| Pfizer Investigational Site | Recruiting |
| Brno, Czech Republic, 65691 | |
| Pfizer Investigational Site | Recruiting |
| Jihlava, Czech Republic, 58633 | |
| Pfizer Investigational Site | Recruiting |
| Plzen - Lochotin, Czech Republic, 304 60 | |
| France | |
| Pfizer Investigational Site | Recruiting |
| Bordeaux, France, 33076 | |
| Pfizer Investigational Site | Not yet recruiting |
| Limoges, France, 87042 | |
| Pfizer Investigational Site | Recruiting |
| Paris Cedex 13, France, 75651 | |
| Germany | |
| Pfizer Investigational Site | Recruiting |
| Altenburg, Germany, 04600 | |
| Pfizer Investigational Site | Not yet recruiting |
| Berlin, Germany, 10117 | |
| Pfizer Investigational Site | Terminated |
| Essen, Germany, 45122 | |
| Pfizer Investigational Site | Recruiting |
| Leipzig, Germany, 04103 | |
| Pfizer Investigational Site | Recruiting |
| Muenchen, Germany, 81675 | |
| Pfizer Investigational Site | Terminated |
| Muenster, Germany, 48149 | |
| Pfizer Investigational Site | Recruiting |
| Regensburg, Germany, 93053 | |
| Hungary | |
| Pfizer Investigational Site | Recruiting |
| Balassagyarmat, Hungary, 2660 | |
| Pfizer Investigational Site | Recruiting |
| Budapest, Hungary, 1145 | |
| Pfizer Investigational Site | Recruiting |
| Budapest, Hungary, 1076 | |
| Pfizer Investigational Site | Recruiting |
| Budapest, Hungary, 1134 | |
| Pfizer Investigational Site | Recruiting |
| Budapest, Hungary, 1083 | |
| Pfizer Investigational Site | Terminated |
| Gyor, Hungary, 9024 | |
| India | |
| Pfizer Investigational Site | Not yet recruiting |
| Hyderabad, Andhra Pradesh, India, 500034 | |
| Pfizer Investigational Site | Recruiting |
| Pune, Maharashtra, India, 411011 | |
| Pfizer Investigational Site | Not yet recruiting |
| New Delhi, India, 110017 | |
| Korea, Republic of | |
| Pfizer Investigational Site | Recruiting |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707 | |
| Pfizer Investigational Site | Recruiting |
| Anyang-si, Gyonggi-do, Korea, Republic of, 431-070 | |
| Pfizer Investigational Site | Active, not recruiting |
| Seoul, Korea, Korea, Republic of, 138-736 | |
| Pfizer Investigational Site | Recruiting |
| Gwangju, Korea, Republic of, 501-757 | |
| Pfizer Investigational Site | Recruiting |
| Incheon, Korea, Republic of, 400-711 | |
| Pfizer Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Pfizer Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Pfizer Investigational Site | Active, not recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Taiwan | |
| Pfizer Investigational Site | Recruiting |
| Kaohsiung, Taiwan, 833 | |
| Pfizer Investigational Site | Recruiting |
| Taichung, Taiwan, 404 | |
| Pfizer Investigational Site | Recruiting |
| Taipei, Taiwan, 100 | |
| Pfizer Investigational Site | Recruiting |
| Taoyuan County, Taiwan, 333 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01208233 History of Changes |
| Other Study ID Numbers: | A9541004 |
| Study First Received: | September 22, 2010 |
| Last Updated: | June 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Phase 2 Ischemic stroke Safety and efficacy |
Additional relevant MeSH terms:
|
Ischemia Stroke Cerebral Infarction Pathologic Processes Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on June 18, 2013