Clinical trial NCT03884452: Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)
Official title: A Phase III Efficacy And Safety Study of Ezetimibe (SCH58235) 10 mg in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Familial Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

* With a diagnosis of homozygous familial hypercholesterolemia
* All females 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, until one month after treatment.
* 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 the study period. ERT, HRT or raloxifene cannot be changed during study period.
* Must follow prescribed or stricter diet, and demonstrate completion of Diet Diaries

Exclusion Criteria:

* A history of mental instability, drug or alcohol abuse; or have been treated or are being treated for severe psychiatric illness which, in the opinion of the Investigator, 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.

Primary outcomes:
measure: Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly
timeFrame: Baseline and Up to Week 12
measure: Percentage of participants with an Adverse Event (AE)
timeFrame: Up to Week 12
Secondary outcomes:
measure: Percent change from baseline in calculated LDL-C
timeFrame: Baseline and Up to Week 12
measure: Percent change from baseline in Total Cholesterol (TC)
timeFrame: Baseline and Up to Week 12
measure: Percent change from baseline in Triglycerides (TG)
timeFrame: Baseline and Up to Week 12
measure: Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C)
timeFrame: Baseline and Up to Week 12
measure: Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C)
timeFrame: Baseline and Up to Week 12
measure: Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C)
timeFrame: Baseline and Up to Week 12
measure: Percent change from baseline in Apolipoprotein A-I (Apo A-I)
timeFrame: Baseline and Up to Week 12
measure: Percent change from baseline in Apolipoprotein B (Apo B)
timeFrame: Baseline and Up to Week 12
measure: Percent change from baseline in Lipoprotein(a) [Lp(a)]
timeFrame: Baseline and Up to Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Gagne C, Gaudet D, Bruckert E; Ezetimibe Study Group. Efficacy and safety of ezetimibe coadministered with atorvastatin or simvastatin in patients with homozygous familial hypercholesterolemia. Circulation. 2002 May 28;105(21):2469-75. doi: 10.1161/01.cir.0000018744.58460.62.