Status:
TERMINATED
Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hyperlipoproteinemia Type II
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01841684
Start Date
June 1 2013
End Date
June 1 2014
Last Update
June 1 2015
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