Clinical trial NCT03882892: Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)
Official title: Long-Term, Safety and Tolerability Study of SCH 58235 or Placebo in Addition to Atorvastatin in Subjects With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2019-03-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants Experiencing ≥1 Adverse Event (AE)
timeFrame: Up to 12 months
measure: Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline and 1.5, 3, 6, 9, and 12 months
measure: Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline and 1.5, 3, 6, 9, and 12 months
measure: Mean Percent Change from Baseline in Triglyceride Levels
timeFrame: Baseline and 1.5, 3, 6, 9, and 12 months
measure: Mean Percent Change from Baseline in Total Cholesterol (TC)
timeFrame: Baseline and 1.5, 3, 6, 9, and 12 months
measure: Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline and 1.5, 3, 6, 9, and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.