Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)

NCT ID: NCT01524289

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-03
• Study Completion Date: 2018-11-13

Brief 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).

Conditions

Hyperlipoproteinemia Type II; Hypercholesterolemia, Familial

Study Design

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

Study Groups

Anacetrapib

Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment period.

Group Type: EXPERIMENTAL

Anacetrapib

Intervention Type: DRUG

One oral tablet, orally once daily for 52 weeks

Placebo

Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One oral tablet once daily for 52 weeks

Interventions

Anacetrapib

One oral tablet, orally once daily for 52 weeks

Intervention Type: DRUG

Placebo

One oral tablet once daily for 52 weeks

Intervention Type: DRUG

Other Intervention Names

MK-0859

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

• 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

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Kastelein JJ, Besseling J, Shah S, Bergeron J, Langslet G, Hovingh GK, Al-Saady N, Koeijvoets M, Hunter J, Johnson-Levonas AO, Fable J, Sapre A, Mitchel Y. Anacetrapib as lipid-modifying therapy in patients with heterozygous familial hypercholesterolaemia (REALIZE): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet. 2015 May 30;385(9983):2153-61. doi: 10.1016/S0140-6736(14)62115-2. Epub 2015 Mar 3.

Reference Type: BACKGROUND

PMID: 25743173 (View on PubMed)

Other Identifiers

2011-004525-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-0859-020

Identifier Type: OTHER

Identifier Source: secondary_id

0859-020

Identifier Type: -

Identifier Source: org_study_id