A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy (MK-0859-021)

NCT ID: NCT01717300

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 459 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-06
• Study Completion Date: 2014-10-29

Brief Summary

This study will evaluate the effects of 2 different dose levels 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-modifying therapy.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Anacetrapib 100 mg

Group Type: EXPERIMENTAL

Anacetrapib 100 mg

Intervention Type: DRUG

100 mg tablet, oral, once daily for 24 weeks

Placebo for anacetrapib 25 mg

Intervention Type: DRUG

Placebo tablet, orally, once daily for 24 weeks

Anacetrapib 25 mg

Group Type: EXPERIMENTAL

Placebo for anacetrapib 100 mg

Intervention Type: DRUG

Placebo tablet, orally, once daily for 24 weeks

Anacetrapib 25 mg

Intervention Type: DRUG

25 mg tablet, oral, once daily for 24 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo for anacetrapib 100 mg

Intervention Type: DRUG

Placebo tablet, orally, once daily for 24 weeks

Placebo for anacetrapib 25 mg

Intervention Type: DRUG

Placebo tablet, orally, once daily for 24 weeks

Interventions

Anacetrapib 100 mg

100 mg tablet, oral, once daily for 24 weeks

Intervention Type: DRUG

Placebo for anacetrapib 100 mg

Placebo tablet, orally, once daily for 24 weeks

Intervention Type: DRUG

Anacetrapib 25 mg

25 mg tablet, oral, once daily for 24 weeks

Intervention Type: DRUG

Placebo for anacetrapib 25 mg

Placebo tablet, orally, once daily for 24 weeks

Intervention Type: DRUG

Other Intervention Names

MK-0859; MK-0859

Eligibility Criteria

Inclusion Criteria

• If female, cannot be of reproductive potential
• Have been treated with an optimal 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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Ballantyne CM, Shah S, Kher U, Hunter JA, Gill GG, Cressman MD, Ashraf TB, Johnson-Levonas AO, Mitchel YB. Lipid-Modifying Efficacy and Tolerability of Anacetrapib Added to Ongoing Statin Therapy in Patients with Hypercholesterolemia or Low High-Density Lipoprotein Cholesterol. Am J Cardiol. 2017 Feb 1;119(3):388-396. doi: 10.1016/j.amjcard.2016.10.032. Epub 2016 Nov 1.

Reference Type: RESULT

PMID: 27956003 (View on PubMed)

Other Identifiers

2012-003110-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0859-021

Identifier Type: -

Identifier Source: org_study_id