drugset / Trial / NCT05601999
Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction
RandomizedParallel-groupDouble-blindTreatment
Summary
GNR-060(JSC "GENERIUM", Russia) is a proposed biosimilar to the referent product Metalyse. This study is to compare the clinical efficacy and safety of GNR-060 vs Metalyse as a thrombolitic agent in patients with with ST Elevation Myocardial Infarction (STEMI).
Timeline
- Start
- 2021-09-03
- Primary completion
- 2024-05-06
- Completion
- 2025-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GNR-060 | Protein / enzyme biologic | — | Intravenous |
| Comparator | Tenecteplase | Protein / enzyme biologic | — | Intravenous |