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)

NCT03882996 | Completed Phase 3

• 2 other identifiers: P01418MK-0653-032
• Study Type: interventional
• Target: 432
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

Ezetimibe 10 mg + Atorvastatin

EXPERIMENTAL

Ezetimibe 10 mg plus atorvastatin 10 to 80 mg daily for up to 12 months

Drug: Ezetimibe; Drug: Atorvastatin

Interventions

Ezetimibe DRUG

Ezetimibe 10 mg daily in the morning

Also known as: Zetia®, SCH 058235, MK-0653

Ezetimibe 10 mg + Atorvastatin

Atorvastatin DRUG

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.

Also known as: Lipitor®, SCH 412387, MK-9396

Ezetimibe 10 mg + Atorvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe; Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 20, 2019
• Study Start: October 6, 2000
• Primary Completion: February 4, 2003
• Study Completion: February 4, 2003
• Last Updated: February 17, 2022

Record last verified: 2022-02