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Victoria: A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Centre Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerlCiguaT Gloobal Study in Subjects With Heart Failure With Reduced Ejection Fraction

People Involved

Professor Andrew Clark

Project Description

This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven trial of MK-1242 (vericiguat) in subjects with heart failure with reduced ejection
fraction (HFrEF).
Approximately 4872 subjects will be randomized globally in this trial to evaluate the efficacy and safety of MK-1242 (vericiguat) compared with placebo, on a background of standard of care.
After a screening phase of up to 30 days, eligible subjects will be treated until the required number of cardiovascular (CV) death events is observed (estimated median follow -up duration of approximately 18 months). All subjects will be followed until study completion to assess for the occurrence of endpoint events. Clinical outcome events will be adjudicated by an independent clinical events committee (CEC). An independent Data Safety and
Monitoring Board (DSMB) will monitor efficacy and safety data.

Type of Project Clinical Trial
Project Acronym Victoria
Status Project Complete
Funder(s) Merck, Sharp and Dohme (UK) Ltd
Value £77,200.00
Project Dates Jan 11, 2017 - Jan 31, 2022

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