Acute Myocardial Infarction Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination With Filgrastim in Early Recovery Post-Myocardial Infarction
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction
Dutogliptin 60 mg administered by twice daily subcutaneous (SC) injection for 14 days in combination with a fixed standard dose of filgrastim (10 µg/kg) administered SC daily for 5 days. This study will be conducted in adults with ST-elevation myocardial infarction (STEMI) with successful revascularization following percutaneous coronary intervention (PCI) and stent implantation. Primary Objective • To evaluate the safety and tolerability of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo Secondary Objectives - To assess preliminary efficacy of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo as determined by cardiac magnetic resonance imaging (cMRI) - To determine the pharmacokinetics (PK) of dutogliptin in a subset of the study population - To establish the pharmacodynamics (PD) of dutogliptin (plasma DPP4 activity) in a subset of the study population Exploratory Objectives - To examine the effects of dutogliptin in combination with filgrastim on: - Change from baseline in plasma stromal cell-derived factor (SDF)-1a levels - Change from baseline in plasma biomarkers, including N-terminal pro-b-type natriuretic peptide (NT-proBNP) and high sensitivity troponin ;
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