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

Hypercholesterolemia Clinical Trial

Official title:

Long-Term, Safety and Tolerability Study of SCH 58235 or Placebo in Addition to Atorvastatin in Subjects With Primary Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882892
• Other study ID #: P02154
• Secondary ID: MK-0653-017P0215
• Status: Completed
• Phase: Phase 3
• Start date: February 2, 2001
• Est. completion date: August 8, 2002

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 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 8, 2002
• Est. primary completion date: August 8, 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 86 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Ezetimibe
Ezetimibe 10 mg tablets
• Atovastatin
Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg
• Placebo
Placebo tablets matched to ezetimibe

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing =1 Adverse Event (AE)		Up to 12 months
Primary	Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)		Up to 12 months
Secondary	Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)		Baseline and 1.5, 3, 6, 9, and 12 months
Secondary	Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)		Baseline and 1.5, 3, 6, 9, and 12 months
Secondary	Mean Percent Change from Baseline in Triglyceride Levels		Baseline and 1.5, 3, 6, 9, and 12 months
Secondary	Mean Percent Change from Baseline in Total Cholesterol (TC)		Baseline and 1.5, 3, 6, 9, and 12 months
Secondary	Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C)		Baseline and 1.5, 3, 6, 9, and 12 months