drugset / Trial / NCT05881382
Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this phase 3, randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of dutogliptin administered subcutaneously (SC) in co-administration with filgrastim in adult patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The primary objective is to evaluate the efficacy of dutogliptin compared with placebo in STEMI patients within 180 days of randomization measured by the time of first occurrence of a composite endpoint of cardiovascular (CV) death and worsening heart failure (HF) within 180 days. Participants will receive dutogliptin twice daily subcutaneously (SC) for 14 days and filgrastim (SC) daily for 5 days or placebo.
Timeline
- Start
- 2023-09
- Primary completion
- 2025-09
- Completion
- 2025-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dutogliptin | Small molecule | 60 mg | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |