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)

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882996
• Other study ID #: P01418
• Secondary ID: MK-0653-032P0141
• Status: Completed
• Phase: Phase 3
• Start date: October 6, 2000
• Est. completion date: February 4, 2003

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: February 4, 2003
• Est. primary completion date: February 4, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

Drug:
• Ezetimibe
Ezetimibe 10 mg daily in the morning
• Atorvastatin
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who experienced an adverse event		Up to 12 months
Primary	Number of participants who discontinued study drug due to an adverse event		Up to 12 months
Secondary	Percentage of participants achieving target LDL-C level (=100 mg/dL)		Up to 12 months
Secondary	Change from baseline in LDL-C levels		Up to 12 months
Secondary	Change from baseline in HDL-C levels		Up to 12 months
Secondary	Change from baseline in triglyceride levels		Up to 12 months