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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00091637 |
In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 30 days.
Condition | Intervention | Phase |
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Acute Myocardial Infarction |
Drug: Pexelizumab Drug: Placebo infusion |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | APEX-AMI - Pexelizumab in Conjunction With Angioplasty |
Enrollment: | 5745 |
Study Start Date: | April 2004 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo infusion
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Drug: Placebo infusion
bolus infusion over a 10 minute period once
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2: Experimental
Pexelizumab infusion
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Drug: Pexelizumab
Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Thomas G Todaro, MD, JD, FACC | Procter and Gamble |
Responsible Party: | Procter and Gamble Pharmaceuticals ( Thomas G Todaro, MD, JD, FACC ) |
Study ID Numbers: | 2003056 |
Study First Received: | September 14, 2004 |
Last Updated: | February 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00091637 |
Health Authority: | United States: Food and Drug Administration |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |