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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

589 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-13

Study Completion Date

2015-08-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anacetrapib

100 mg tablet, oral, once daily for 24 weeks

Group Type EXPERIMENTAL

Anacetrapib

Intervention Type DRUG

Placebo

Matching tablet to Anacetrapib 100 mg, oral, once daily for 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Anacetrapib

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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MK-0859

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No