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

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Placebo for anacetrapib 100 mg; Drug: Anacetrapib 100 mg; Drug: Placebo for anacetrapib 25 mg; Drug: Anacetrapib 25 mg

• Registration Number: NCT01717300
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-26
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Study Start: 2012-11-06
• Primary Completion: 2014-10-29
• Study Completion: 2014-10-29
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anacetrapib 100 mg	Placebo for anacetrapib 25 mg	-
Anacetrapib 25 mg	Placebo for anacetrapib 100 mg	-
Anacetrapib 25 mg	Anacetrapib 25 mg	-
Placebo	Placebo for anacetrapib 100 mg	-
Placebo	Placebo for anacetrapib 25 mg	-
Anacetrapib 100 mg	Anacetrapib 100 mg	-

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in HDL-C	Baseline and Week 24
Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)	Baseline and Week 24
Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal)	24 Weeks
Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms	24 weeks
Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal)	24 weeks
Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause	24 weeks
Number of Participants with Significant Increase in Blood Pressure	24 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change from Baseline in non-HDL-C	Baseline and Week 24
Percent Change from Baseline in Apolipoprotein B (Apo-B)	Baseline and Week 24
Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)	Baseline and Week 24
Percent Change from Baseline in Lipoprotein(a) (lp[a])	Baseline and Week 24
Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal	Baseline and Week 24