Study of Primary Hypercholesterolemia or Mixed Dyslipidemia Patients
Research type
Research Study
Full title
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia
IRAS ID
74591
Contact name
Terry McCormack
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2010-021627-27
Clinicaltrials.gov Identifier
Research summary
There is a direct relationship between the reduction in low-density lipoprotein-cholesterol (LDL-C) levels in the blood and cardiovascular risk reduction. Further studies also suggest that low levels of high density L-C (HDL-C) and high levels of triglycerides (TG) are associated with increased cardiovascular disease risk. Combination treatment to target LDL-C levels as well as other arterial wall thickening lipid materials may result in an increased clinical benefit above the current standard therapy to lower LDL-C.This 12-week, double-blind, phase III study plans to recruit patients with heart disease or diseased blood vessels or at high risk of developing these problems, who have an inherited problem with their cholesterol and who are currently receiving an eligible lipid-modifying therapy (LMT). Approximately 1424 patients globally will be randomised in a 1:1 ratio to Extended Release Niacin/Laropiprant (ERN/LRPT) or placebo (sugar pill). At Day 1 eligible patients, who have signed an informed consent form, will be randomized a new treatment to lower their cholesterol and other fats (ERN/LRPT)or placebo on Day 1. After 4 weeks, the ERN/LRPT dose will be for the remainder of the study. Patients on placebo will continue on matching doses of placebo till the end of treatment in this study. Throughout the study, patients will undergo blood test, ECGs, urine tests, physical examinations and BP and pulse rate measurements. Patients can also consent to optional sub-study where a blood sample will be taken for genetic and other biomedical testing.The primary objective of this study is to evaluate the efficacy of ERN/LRPT 2 g relative to placebo on plasma LDL-C at Week 12 of treatment in patients with primary hypercholesterolemia or mixed dyslipidemia on stable LMT and with elevated LDL-C.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
11/NE/0073
Date of REC Opinion
31 May 2011
REC opinion
Further Information Favourable Opinion