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)

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Ezetimibe; Drug: Atorvastatin

• Registration Number: NCT03882996
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Adult participants with a diagnosis of HeFH or CHD or multiple risk factors (≥2) and with primary hypercholesterolemia who had successfully completed the 14-week, double-blind efficacy and safety study of ezetimibe co-administered with atorvastatin (Protocol No. P00693/MK-0653-030; NCT03867318) were eligible for enrollment in this long-term extension study.

Study Timeline

• Study Start: 2000-10-06
• Primary Completion: 2003-02-04
• Study Completion: 2003-02-04
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

• Participants who have successfully completed the 14-week double-blind, efficacy and safety study of SCH 58235 in addition to atorvastatin in participants with CHD or multiple risk factors or HeFH, (Protocol P00693/MK-0653-030; NCT03867318). Entry into this protocol must occur at the time of completion of Protocol P00693/MK-0653-030; NCT03867318
• All women must have a negative pregnancy test prior to study entry. Women of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study. In addition, participants must agree to practice an effective barrier method of birth control for 30 days following the last dose of atorvastatin administered
• Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen during study period

Exclusion Criteria

• Participants who discontinued from the Protocol P00693 due to adverse events or poor compliance
• Pregnant or lactating women
• Participants who are known to be HIV positive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ezetimibe 10 mg + Atorvastatin	Ezetimibe	Ezetimibe 10 mg plus atorvastatin 10 to 80 mg daily for up to 12 months
Ezetimibe 10 mg + Atorvastatin	Atorvastatin	Ezetimibe 10 mg plus atorvastatin 10 to 80 mg daily for up to 12 months

Primary Outcome Measures

Name	Time	Method
Number of participants who discontinued study drug due to an adverse event	Up to 12 months
Number of participants who experienced an adverse event	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in triglyceride levels	Up to 12 months
Change from baseline in LDL-C levels	Up to 12 months
Change from baseline in HDL-C levels	Up to 12 months
Percentage of participants achieving target LDL-C level (≤100 mg/dL)	Up to 12 months