Study to Assess the Tolerability and Efficacy of Anacetrapib Co-administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020 AM1)
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | February 2012 |
| End Date: | June 2014 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
A 1-Year, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo- Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients With Heterozygous Familial Hypercholesterolemia
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.
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 mediation
- 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
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