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A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk

Status
Withdrawn
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502781-24-00
Acronym
MK 0616-015
Enrollment
350
Registered
2023-11-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

ASCVD - Atherosclerotic Cardiovascular Disease

Brief summary

CHD death-based MACE plus

Detailed description

3-point MACE, CV death-based MACE plus, Coronary heart disease death or MI, Cardiovascular death, All-cause death, Time to first event of MI, ischemic stroke, acute limb ischemia or major amputation, and urgent arterial revascularization, Percent change from baseline in LDL-C, Percent change from baseline in Apolipoprotein B, Percent change from baseline in Non-HDL-C, Percent change from baseline in Lipoprotein (a), Number of participants with an adverse event (AE), Number of participants discontinuing from study intervention due to AE

Interventions

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
CHD death-based MACE plus

Secondary

MeasureTime frame
3-point MACE, CV death-based MACE plus, Coronary heart disease death or MI, Cardiovascular death, All-cause death, Time to first event of MI, ischemic stroke, acute limb ischemia or major amputation, and urgent arterial revascularization, Percent change from baseline in LDL-C, Percent change from baseline in Apolipoprotein B, Percent change from baseline in Non-HDL-C, Percent change from baseline in Lipoprotein (a), Number of participants with an adverse event (AE), Number of participants discontinuing from study intervention due to AE

Countries

Denmark

Outcome results

None listed

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