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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT03884452
• Date of registration: 06/03/2019
• Prospective Registration: No
• Primary sponsor: Organon and Co
• Public title: Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)
• Scientific 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
• Date of first enrolment: May 3, 2000
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03884452
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Familial Hypercholesterolemia

Intervention(s)

Drug: Atorvastatin

Drug: Simvastatin

Drug: Ezetimibe

Drug: Placebo for Ezetimibe

Primary Outcome(s)

Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly [Time Frame: Baseline and Up to Week 12]

Percentage of participants with an Adverse Event (AE) [Time Frame: Up to Week 12]

Secondary Outcome(s)

Percent change from baseline in calculated LDL-C [Time Frame: Baseline and Up to Week 12]

Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C) [Time Frame: Baseline and Up to Week 12]

Percent change from baseline in Lipoprotein(a) [Lp(a)] [Time Frame: Baseline and Up to Week 12]

Percent change from baseline in Triglycerides (TG) [Time Frame: Baseline and Up to Week 12]

Percent change from baseline in Apolipoprotein A-I (Apo A-I) [Time Frame: Baseline and Up to Week 12]

Percent change from baseline in Apolipoprotein B (Apo B) [Time Frame: Baseline and Up to Week 12]

Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C) [Time Frame: Baseline and Up to Week 12]

Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C) [Time Frame: Baseline and Up to Week 12]

Percent change from baseline in Total Cholesterol (TC) [Time Frame: Baseline and Up to Week 12]

Secondary ID(s)

MK-0653-018

P01030

Source(s) of Monetary Support

Please refer to primary and secondary sponsors