Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)

Last updated: May 8, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Familial Hypercholesterolemia

High Cholesterol (Hyperlipidemia)

Dyslipidemia

Treatment

Simvastatin

Ezetimibe

Atorvastatin

Clinical Study ID

NCT03884452
P01030
MK-0653-018
P01030
  • Ages > 12
  • All Genders

Study Summary

The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • With a diagnosis of homozygous familial hypercholesterolemia
  • All females must have a negative pregnancy test prior to study entry. Women of childbearing potential must agree to practice an effective barrier method of birth controlfor the duration of the study, until one month after treatment.
  • Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifenemust be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifeneregimen during the study period. ERT, HRT or raloxifene cannot be changed during studyperiod.
  • Must follow prescribed or stricter diet, and demonstrate completion of Diet Diaries

Exclusion

Exclusion Criteria:

  • A history of mental instability, drug or alcohol abuse; or have been treated or arebeing treated for severe psychiatric illness which, in the opinion of theInvestigator, may interfere with optimal participation in the study.
  • With underlying disease likely to limit life span to less than 1 year.
  • Have previously been randomized in any studies examining ezetimibe
  • Pregnant or lactating women.
  • With known hypersensitivity or any contraindication to statin therapy.

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Simvastatin
Phase: 3
Study Start date:
May 03, 2000
Estimated Completion Date:
May 24, 2001