Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)
Phase 3
Completed
- Conditions
- Familial Hypercholesterolemia
- Interventions
- Registration Number
- NCT03884452
- Lead Sponsor
- Organon and Co
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atorvastatin 80 mg Placebo for Ezetimibe 80 mg atorvastatin taken orally, once daily for 12 weeks Ezetimibe + Atorvastatin 40 mg Atorvastatin 10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks Ezetimibe + Atorvastatin 40 mg Ezetimibe 10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks Ezetimibe + Atorvastatin 80 mg Ezetimibe 10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks Ezetimibe + Simvastatin 80 mg Simvastatin 10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks Ezetimibe + Simvastatin 40 mg Simvastatin 10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks Atorvastatin 80 mg Atorvastatin 80 mg atorvastatin taken orally, once daily for 12 weeks Ezetimibe + Atorvastatin 80 mg Atorvastatin 10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks Simvastatin 80 mg Placebo for Ezetimibe 80 mg simvastatin taken orally, once daily for 12 weeks Ezetimibe + Simvastatin 80 mg Ezetimibe 10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks Simvastatin 80 mg Simvastatin 80 mg simvastatin taken orally, once daily for 12 weeks Ezetimibe + Simvastatin 40 mg Ezetimibe 10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of participants with an Adverse Event (AE) Up to Week 12 Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly Baseline and Up to Week 12
- Secondary Outcome Measures
Name Time Method Percent change from baseline in Total Cholesterol (TC) Baseline and Up to Week 12 Percent change from baseline in Triglycerides (TG) Baseline and Up to Week 12 Percent change from baseline in Apolipoprotein B (Apo B) Baseline and Up to Week 12 Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C) Baseline and Up to Week 12 Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C) Baseline and Up to Week 12 Percent change from baseline in Apolipoprotein A-I (Apo A-I) Baseline and Up to Week 12 Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C) Baseline and Up to Week 12 Percent change from baseline in Lipoprotein(a) [Lp(a)] Baseline and Up to Week 12 Percent change from baseline in calculated LDL-C Baseline and Up to Week 12