Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction
Sponsor: AO GENERIUM
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).
Official title: Multicenter Randomized Single Blind Study of the Clinical Efficacy and Safety of GNR-060 (JSC "GENERIUM", Russia) Compared to Metalyse (Boehringer Ingelheim Pharma GmbH & Co.KG, Germany) in Patients With ST Elevation Myocardial Infarction
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
244
Start Date
2021-09-03
Completion Date
2025-01-15
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
GNR-060
GNR-060 will be administered in an individual dose depending on body weight as a single intravenous bolus
Metalyse
Metalyse will be administered in an individual dose depending on body weight as a single intravenous bolus
Locations (11)
Regional State Budgetary Health Institution "Regional Clinical Emergency Hospital"
Barnaul, Altai Territory, Russia
Regional State Budgetary Institution of Health Care "Altai Territorial Cardiology Dispensary"
Barnaul, Altai Territory, Russia
State Budgetary Institution of Health Care of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"
Arkhangelsk, Arkhangelskaya oblast, Russia
Regional State Budgetary Health Institution "Belgorod Regional Clinical Hospital of St. Joasaph"
Belgorod, Belgorod Oblast, Russia
State Autonomous Healthcare Institution of the Perm Territory "City Clinical Hospital No. 4"
Perm, Perm Territory, Russia
Municipal budgetary health care institution "City emergency hospital of the city of Rostov-on-Don"
Rostov-on-Don, Rostov Oblast, Russia
State Budgetary Institution of the Ryazan Region "Regional Clinical Hospital"
Ryazan, Ryazan Oblast, Russia
State budgetary health care institution of the Sverdlovsk region "Scientific and practical center for specialized types of medical care" Ural Institute of Cardiology "
Yekaterinburg, Sverdlovsk Oblast, Russia
State Autonomous Healthcare Institution "Interregional Clinical and Diagnostic Center"
Kazan', Tatarstan Republic, Russia
State Health Institution "City Clinical Emergency Hospital No. 25"
Volgograd, Volgograd Oblast, Russia
State Budgetary Health Institution of the Yaroslavl Region "Regional Clinical Hospital"
Yaroslavl, Yaroslavl Oblast, Russia