A Study of the Safety and Efficacy of Anacetrapib (MK-0859) Among Participants With Hypercholesterolemia When Added to Ongoing Statin Therapy
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000937
- Lead Sponsor
- MSD Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 800
If female, cannot be of reproductive potential
Has been treated with an appropriate dose of statins with or without other lipid modifying therapy 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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of anacetrapib 100 mg for 24 weeks relative to placebo on plasma concentrations of LDL-C (BQ method).;To evaluate the efficacy of anacetrapib 100 mg for 24 weeks relative to placebo on plasma concentrations of HD
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of adding anacetrapib 100 mg for 24 weeks relative to placebo on plasma concentrations of non-HDL-C, apo B, apoA-I, Lp(a);To assess the effect of anacetrapib 100 mg on HDL-C in patients with low HDL-C at LDL-C goal after 24 weeks of treatment