NCT03867110

An Efficacy and Safety Study of Ezetimibe (MK-0653, SCH 58235) in Addition to Atorvastatin Compared to Placebo in Participants With Primary Hypercholesterolemia (MK-0653-013)

A Phase 3, Double-Blind Efficacy and Safety Study of Ezetimibe (SCH 58235) 10 mg in Addition to Atorvastatin Compared to Placebo in Subjects With Primary Hypercholesterolemia (Protocol P00692)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 628 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, balanced-parallel-group, efficacy and safety trial of ezetimibe coadministered with atorvastatin in adult participants with primary hypercholesterolemia. The primary hypothesis is that the coadministration of ezetimibe 10 mg/day with atorvastatin (pooled across all doses: 10 mg, 20 mg, 40 mg, 80 mg) will result in a significantly greater reduction in direct low density lipoprotein-cholesterol (LDL-C) when compared with atorvastatin (pooled across all doses: 10 mg, 20 mg, 40 mg, 80 mg) alone and ezetimibe 10 mg alone.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	Ezetimibe 10 mg
DRUG	Atorvastatin 10 mg
DRUG	Atorvastatin 20 mg
DRUG	Atorvastatin 40 mg
DRUG	Atorvastatin 80 mg

Timeline

• Start date: 2000-03-06
• Primary completion: 2001-07-27
• Completion: 2001-07-27
• First posted: 2019-03-07
• Last updated: 2024-05-10

Regulatory

• FDA-regulated drug study