drugset / Trial / NCT03882996

A Long-term Safety and Tolerability Study of Ezetimibe Plus Atorvastatin in Participants With Coronary Heart Disease, Multiple Risk Factors, or Hypercholesterolemia Not Controlled by Atorvastatin (P01418/MK-0653-032)

NCT03882996

Phase 3 Completed 432 enrolled Organon and Co
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate the long-term safety and tolerability of ezetimibe 10 mg once daily co-administered with atorvastatin 10 to 80 mg daily for up to 12 consecutive months in participants with heterozygous familial hypercholesterolemia (HeFH) or in participants with coronary heart disease (CHD) or multiple cardiovascular risk factors and primary hypercholesterolemia not controlled by a starting dose (10 mg daily) of atorvastatin.

Timeline

Start
2000-10-06
Primary completion
2003-02-04
Completion
2003-02-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 10 mg
Subject Ezetimibe Unknown 10 mg

Indications