drugset / Trial / NCT03882892

Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)

NCT03882892

Phase 3 Completed 400 enrolled Organon and Co
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.

Timeline

Start
2001-02-02
Primary completion
2002-08-08
Completion
2002-08-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg
Background Atorvastatin Small molecule 10 mg
Background Atorvastatin Small molecule 20 mg
Background Atorvastatin Small molecule 40 mg
Background Atorvastatin Small molecule 80 mg

Indications