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

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Ezetimibe; Drug: Atovastatin; Drug: Placebo

• Registration Number: NCT03882892
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

This study is a long-term extension study of the protocol P00692 parent study.

Study Timeline

• Study Start: 2001-02-02
• Primary Completion: 2002-08-08
• Study Completion: 2002-08-08
• 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: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Has successfully completed the 12-week double-blind, efficacy and safety parent study (P00692).
• If female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose.
• If postmenopausal female receiving hormone therapy, a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen must be maintained during the study period.
• Is willing to continue to follow their prescribed National Cholesterol Education Program (NCEP) Step 1 diet for the duration of the study.

Exclusion Criteria

• Has discontinued from the parent study (P00692) prior to study completion.
• Is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation.
• Is a pregnant or lactating female.
• Is human immunodeficiency virus (HIV) positive.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ezetimibe + Atorvastatin	Atovastatin	Participants who received ezetimibe + atorvastatin, or atorvastatin alone, in the parent study (P00692) receive ezetimibe (blinded) + atorvastatin (10 mg/day; open-label) in this study.
Placebo + Atorvastatin	Atovastatin	Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study.
Placebo + Atorvastatin	Placebo	Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study.
Ezetimibe + Atorvastatin	Ezetimibe	Participants who received ezetimibe + atorvastatin, or atorvastatin alone, in the parent study (P00692) receive ezetimibe (blinded) + atorvastatin (10 mg/day; open-label) in this study.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing ≥1 Adverse Event (AE)	Up to 12 months
Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)	Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Triglyceride Levels	Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)	Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Total Cholesterol (TC)	Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C)	Baseline and 1.5, 3, 6, 9, and 12 months