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

NCT ID: NCT03882892

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-02
• Study Completion Date: 2002-08-08

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo + Atorvastatin

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

Group Type: PLACEBO_COMPARATOR

Atovastatin

Intervention Type: DRUG

Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg

Placebo

Intervention Type: DRUG

Placebo tablets matched to ezetimibe

Ezetimibe + Atorvastatin

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.

Group Type: EXPERIMENTAL

Ezetimibe

Intervention Type: DRUG

Ezetimibe 10 mg tablets

Atovastatin

Intervention Type: DRUG

Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg

Interventions

Ezetimibe

Ezetimibe 10 mg tablets

Intervention Type: DRUG

Atovastatin

Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg

Intervention Type: DRUG

Placebo

Placebo tablets matched to ezetimibe

Intervention Type: DRUG

Other Intervention Names

SCH 58235

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Ballantyne CM, Lipka LJ, Sager PT, Strony J, Alizadeh J, Suresh R, Veltri EP. Long-term safety and tolerability profile of ezetimibe and atorvastatin coadministration therapy in patients with primary hypercholesterolaemia. Int J Clin Pract. 2004 Jul;58(7):653-8. doi: 10.1111/j.1368-5031.2004.00278.x.

Reference Type: RESULT

PMID: 15311720 (View on PubMed)

Other Identifiers

MK-0653-017

Identifier Type: OTHER

Identifier Source: secondary_id

P02154

Identifier Type: OTHER

Identifier Source: secondary_id

P02154

Identifier Type: -

Identifier Source: org_study_id