Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)
Condition: Hyperlipoproteinemia Type II; Hypercholesterolemia, Familial
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Hyperlipoproteinemias; Hyperlipidemias
Intervention: Anacetrapib; Placebo
Intervention description: One oral tablet, orally once daily for 52 weeks; One oral tablet once daily for 52 weeks
Intervention MeSH terms: Anacetrapib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the efficacy and tolerability of adding
      anacetrapib to ongoing statin therapy in participants with heterozygous familial
      hypercholesterolemia (HeFH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  If of reproductive potential, must agree to remain abstinent or use (or have their
             partner use) 2 acceptable methods of birth control for the duration of the study

          -  Diagnosed with Heterozygous Familial Hypercholesterolemia (HeFH)

          -  Have been treated with an optimal dose of statin for at least 6 weeks

        Exclusion Criteria:

          -  Received treatment with low-density lipoprotein (LDL) apheresis within 4 weeks of
             screening or expect to undergo treatment with LDL apheresis during the course of the
             study

          -  Homozygous familial hypercholesterolemia

          -  Severe chronic heart failure

          -  Uncontrolled hypertension

          -  Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary
             intervention (PCI), coronary artery bypass graft (CABG), unstable angina, or stroke
             within 3 months

          -  Uncontrolled endocrine or metabolic disease known to influence serum lipids or
             lipoproteins

          -  Active or chronic hepatobiliary, hepatic, or gall bladder disease

          -  Pregnant or breast-feeding, or plans to become pregnant during the study or within 2
             years after stopping study medication

          -  History of ileal bypass, gastric bypass, or other significant condition associated
             with malabsorption

          -  Human immunodeficiency virus (HIV) positive

          -  History of malignancy ≤5 years

          -  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

          -  Currently taking medications that are potent inhibitors or inducers of cytochrome P450
             3A4 (CYP3A) (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

          -  Consumes more than 2 alcoholic drinks per day

          -  Currently participating or has participated in a study with an investigational
             compound or device within 3 months

          -  Receiving treatment with systemic corticosteroids or taking systemic anabolic agents