A Study of the Safety and Efficacy of Anacetrapib (MK-0859) Among Participants With Hypercholesterolemia When Added to Ongoing Statin Therapy (MK-0859-022)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Hypercholesterolemia

Treatments

Drug: Anacetrapib

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01860729

0859-022

Details and patient eligibility

About

This study will evaluate the effects of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with hypercholesterolemia when added to an existing statin therapy.

Enrollment

589 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

If female, cannot be of reproductive potential
Has been treated with an appropriate dose of statin for at least 6 weeks
Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple risk factors (including diabetes, metabolic syndrome) and/or high LDL-C/low HDL-C, or needing to meet a specific LDL-C/HDL-C goal

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
Uncontrolled hypertension
Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
Active or chronic hepatobiliary, hepatic, or gall bladder disease
History of mental instability, drug/alcohol abuse within the past five years or major psychiatric illness inadequately controlled and unstable
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