A Study of the Safety and Efficacy of Anacetrapib (MK-085... | NCT01717300

ID	Type	Description	Link
2012-003110-14	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Anacetrapib 100 mg	Experimental	Drug: Anacetrapib 100 mg Drug: Placebo for anacetrapib 25 mg
Anacetrapib 25 mg	Experimental	Drug: Placebo for anacetrapib 100 mg Drug: Anacetrapib 25 mg
Placebo	Placebo Comparator	Drug: Placebo for anacetrapib 100 mg Drug: Placebo for anacetrapib 25 mg

Name	Type	Description	Arm Group Labels	Other Names
Anacetrapib 100 mg	Drug	100 mg tablet, oral, once daily for 24 weeks	Anacetrapib 100 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)		Baseline and Week 24
Percent Change from Baseline in HDL-C		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 Outcomes

Measure	Description	Time Frame
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)

Eligibility Module

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27956003	Result	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.

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases