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

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Anacetrapib 100 mg Drug: Placebo for anacetrapib 100 mg Drug: Anacetrapib 25 mg Drug: Placebo for anacetrapib 25 mg	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A 24-Week, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients With Hypercholesterolemia or Low HDL-C

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins

Genetic and Rare Diseases Information Center resources: Sphingolipidosis

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Percent Change from Baseline in HDL-C [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Number of Participants with Significant Increase in Blood Pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent change from Baseline in non-HDL-C [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Percent Change from Baseline in Apolipoprotein B (Apo-B) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Percent Change from Baseline in Lipoprotein(a) (lp[a]) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]


Enrollment:	459
Study Start Date:	November 2012
Study Completion Date:	October 2014
Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Anacetrapib 100 mg	Drug: Anacetrapib 100 mg 100 mg tablet, oral, once daily for 24 weeks Other Name: MK-0859 Drug: Placebo for anacetrapib 25 mg Placebo tablet, orally, once daily for 24 weeks
Experimental: Anacetrapib 25 mg	Drug: Placebo for anacetrapib 100 mg Placebo tablet, orally, once daily for 24 weeks Drug: Anacetrapib 25 mg 25 mg tablet, oral, once daily for 24 weeks Other Name: MK-0859
Placebo Comparator: Placebo	Drug: Placebo for anacetrapib 100 mg Placebo tablet, orally, once daily for 24 weeks Drug: Placebo for anacetrapib 25 mg Placebo tablet, orally, once daily for 24 weeks

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01717300 History of Changes
Other Study ID Numbers:	0859-021, 2012-003110-14
Study First Received:	October 26, 2012
Last Updated:	December 5, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Anacetrapib Oxazolidinones Anti-Infective Agents Anticholesteremic Agents	Antimetabolites Enzyme Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Synthesis Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015