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A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500881-80-00
Acronym
MK-1242-035
Enrollment
2214
Registered
2023-04-26
Start date
2021-10-29
Completion date
2025-01-28
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Brief summary

Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization

Detailed description

Time to First Occurrence of CV Death, Time to First Occurrence of HF Hospitalization, Time to Total HF Hospitalizations (Including First and Recurrent Events), Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization, Time to All-Cause Mortality, Percentage of Participants who Experienced One or More Selected Nonserious Adverse Events (NSAE), Percentage of Participants Who Experienced One or More Serious Adverse Events (SAE), Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECI)

Interventions

DRUGPlacebo to MK-1242 tablet 2.5 and 5 mg
DRUGPlacebo to MK-1242 tablet 10 mg
DRUGVericiguat

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization

Secondary

MeasureTime frame
Time to First Occurrence of CV Death, Time to First Occurrence of HF Hospitalization, Time to Total HF Hospitalizations (Including First and Recurrent Events), Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization, Time to All-Cause Mortality, Percentage of Participants who Experienced One or More Selected Nonserious Adverse Events (NSAE), Percentage of Participants Who Experienced One or More Serious Adverse Events (SAE), Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECI)

Countries

Austria, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026