Heterozygous Familial Hypercholesterolemia (HeFH)
Conditions
Brief summary
This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying therapy.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* If female, cannot be of reproductive potential * Diagnosed with heterozygous familial hypercholesterolemia * Have been treated with an appropriate and stable dose of statin± other lipid-lowering medication(s) for at least 6 weeks
Exclusion criteria
* Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor * Homozygous familial hypercholesterolemia * Severe chronic heart failure * Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) | Baseline and Week 12 |
| Percentage of Participants who Experience at Least One Adverse Event (AE) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Apolipoprotein B (Apo-B) | Baseline and Week 12 |
| Percent Change from Baseline in Non-HDL-C | Baseline and Week 12 |
| Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C) | Baseline and Week 12 |
| Percent Change from Baseline in Lipoprotein(a) (Lp[a]) | Baseline and Week 12 |
| Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) | Baseline and Week 12 |
Outcome results
None listed