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)

Long-Term, Open-Label, Safety and Tolerability Study of Ezetimibe (SCH 58235) in Addition to Atorvastatin in Subjects With Coronary Heart Disease or Multiple Risk Factors and With Primary Hypercholesterolemia Not Controlled by a Starting Dose (10 mg) of Atorvastatin

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03882996

Enrollment

432

Registered

2019-03-20

Start date

2000-10-06

Completion date

2003-02-04

Last updated

2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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.

Interventions

DRUGEzetimibe

Ezetimibe 10 mg daily in the morning

DRUGAtorvastatin

Atorvastatin 10 mg daily in the morning. Atorvastatin dose could be titrated up (by doubling the dose up to a maximum of 80 mg daily) to achieve the target low-density-lipoprotein cholesterol (LDL-C) level of 100 mg/dL (2.59 mmol/L) after a minimum of 4 weeks of treatment.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026