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Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)

NCT03768427 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2024-05-16

Study results available
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Summary

This study will evaluate the EZ/Ator fixed-dose combination (FDC) tablet (MK-0653C) as second line Low-Density Lipoprotein - Cholesterol (LDL-C) treatment in Chinese participants. The primary hypothesis is that MK-0653C 10/10 mg is superior to atorvastatin 20 mg in percent change from baseline in LDL-C to 12 weeks after treatment.

Conditions

Interventions

COMBINATION_PRODUCT

EZ 10 mg/Ator 10 mg

FDC of EZ10 mg/Ator 10mg

COMBINATION_PRODUCT

EZ 10 mg/Ator 20 mg

FDC of EZ10 mg/Ator 20mg

DRUG

Atorvastatin

Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets

DRUG

Placebo for FDC EZ/Ator

A single placebo tablet administered orally QD for 84 days

DRUG

Placebo for atorvastatin

Two placebo tablets matching atorvastatin administered orally QD for 84 days

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2021-03-17
Completion
2021-04-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03768427 on ClinicalTrials.gov