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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Ezetimibe; Drug: Placebo; Drug: Atovastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03882892

P02154 (Other Identifier)

MK-0653-017 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 86 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Placebo + Atorvastatin

Placebo Comparator group

Description:

Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study.

Treatment:

Drug: Placebo

Drug: Atovastatin

Ezetimibe + Atorvastatin

Experimental group

Description:

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.

Treatment:

Drug: Atovastatin

Drug: Ezetimibe