Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This study will evaluate the safety and effect of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy. The primary hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower LDL-C to a greater extent than treatment with placebo.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosed with HoFH by genotyping
- If female, cannot be of reproductive potential
- Have been stabilized on statin monotherapy or statin therapy coadministered
with other lipid medications for at least 6 weeks
Exclusion criteria
- Severe chronic heart failure defined by New York Heart Association
(NYHA) Classes III or IV
- Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary arterial by-pass graft (CABG), unstable angina or stroke within 3 months prior to Visit 1 or has planned procedures scheduled within first 12 weeks of study
- Uncontrolled endocrine or metabolic disease known to influence serum
lipids or lipoproteins
- Active or chronic hepatobiliary or gall bladder disease
- History of ileal bypass, gastric bypass, or other significant condition
associated with malabsorption
- Human immunodeficiency virus (HIV) positive
- Donated blood products or has had phlebotomy of >300 mL within 8 weeks or intends to donate 250_mL of blood products or receive blood products within the projected duration of the study
- Taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A4), including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's wort) or has discontinued treatment <3 weeks prior. Consumption of >1 liter of grapefruit juice per day is also prohibited.
- Currently participating or has participated in a study with an investigational compound or device within 3 months
- Consume more than 2 alcoholic drinks per day
- Receiving treatment with systemic corticosteroids or systemic anabolic agents
Trial design
Primary purpose
Allocation
Interventional model
Masking
2 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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