Status and phase
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About
This is a multicenter, randomized, double-blind, placebo-controlled study in participants with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER) niacin/laropiprant [ERN/LRPT (MK-0524A)] when added to the following ongoing lipid-modifying therapy (LMT): simvastatin,
atorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC), or any statin co-administered with ezetimibe. The study is based on the hypothesis that ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Has a history of primary hypercholesterolemia or mixed dyslipidemia.
Must meet one of the risk categories (very high, high or moderate and corresponding LDL-C criteria at Visit 2.
Has TG levels <500 mg/dL (<5.65 mmol/L).
Has been on a stable dose of one of the following lipid-modifying therapies (LMTs)for at least 6 weeks prior to Visit 1, and agrees to remain on the same type and dose of LMT for the duration of the study:
Is male or female and ≥18 years of age on day of signing informed consent.
A female must meet ONE of the following:
Of reproductive potential and agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the study duration.
Not of reproductive potential is eligible without requiring the use of contraception. Definition of "not of reproductive potential": one who has either of the following:
Understands the study's procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
Exclusion Criteria
prohibited LMT include bile acid sequestrants, fibrates (monotherapy, coadministration or combination with other LMT), niacin >50 mg, and red yeast rice products.
Has had a change to the type or dose of acceptable LMT regimen within 6 weeks of Visit 1.
Is pregnant, breastfeeding, or expecting to conceive during the study including the 14-day poststudy follow-up.
Has a history of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Female who is expecting to donate eggs during the study, including the 14-day follow-up.
Is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
Has participated in a study, including post-study follow-up, with an investigational compound (non-lipid-modifying) within 30 days of Visit 1 or a lipid-modifying compound (investigational or marketed), within 6 weeks of Visit 1.
Has donated and/or received blood as follows:
Has the following exclusionary laboratory values at Visit 2
Has used recreational or illicit drugs within 1 year of signing informed consent.
Was <80% compliant with LMT or placebo at Visit 2, AND in the opinion of the investigator, is believed to be unable to maintain at least 80% compliance with dosing during the active treatment period.
Has chronic heart failure defined by the New York Heart Association (NYHA) Classes III or IV, uncontrolled cardiac arrhythmias, or poorly controlled hypertension (systolic blood pressure >160 mm Hg or diastolic >100 mm Hg).
Has Type 1 or Type 2 diabetes mellitus and meets one or more of the following criteria:
Has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia such as hyper- or hypothyroidism.
Has nephrotic syndrome or other clinically significant renal disease.
Has active peptic ulcer disease within 3 months of Visit 1.
Has a history of hypersensitivity or allergic reaction to niacin or niacin containing products.
Has history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.
Has arterial bleeding.
Has a history of ileal bypass, gastric bypass or other significant condition associated with malabsorption or rapid weight loss within 18 months of Visit 1.
Has active or chronic hepatobiliary or hepatic disease.
Is Chinese and is on simvastatin 80 mg or a product containing simvastatin 80 mg at Visit 1.
Is receiving treatment with systemic steroids (intravenous, injected, and oral steroids) OR systemic anabolic agents.
Consumes more than 3 alcoholic drinks on any given day or more than 14 drinks per week.
Is taking the following antioxidant vitamins each day:
Primary purpose
Allocation
Interventional model
Masking
1,173 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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