143-Phase 3 Study in Primary Hypercholesteremia or Mixed Dyslipidemia

• Research type

  Research Study

• Full title

  A Phase III Multicenter, Double-Blind, Crossover Design Study to Evaluate Lipid-Altering Efficacy and Safety of 1 g/10 mg Extended-Release Niacin/Laropiprant/Simvastatin Combination Tablets in Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia

• IRAS ID

  69236

• Contact name

  Mark Blagden

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2011-001007-12

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Increased levels of total cholesterol (TC), low density lipoprotein cholesterol (LDLC), non high DLC, apolipoprotein B and triglycerides (TG), together with low levels of high DLC, apolipoprotein A1 have been shown with an increased cardiovascular risk.This research study will test the safety & efficacy of combining extended release niacin laropiprant simvastatin (MK-0524B) in the management of cholesterol levels. The use of MK-0524B is investigational. About 1268 patients with primary hypercholesterolemia or mixed dyslipidemia, both men and women 18 to 85 years of age, will take part in the study. Patients will be in the study for about 24 - 30 weeks (plus a 2 week post study follow-up period) depending on the medications they are taking to manage the types of fats in their blood prior to the study.Following the pre-screening/ washout period eligible patients will be randomized in a 1:1 ratio to receive either Extended Release Niacin/Laropiprant/Simvastatin (ERN/LRPT/SIM) 1g/10mg placebo or ERN/LRPT 1g plus SIM 10mg co-administration. After 4 weeks of treatment, treatment doses of ERN/LRPT will be increased in both treatment groups for an additional 8 weeks (ERN/LRPT/SIM 1g/10mg tablet x2 placebo x2 or ERN/LRPT 1g tablet x2 plus SIM 10mg tablet x2 co-administration). After this, patients on ERN/LRPT/SIM combination will crossover to the ERN/LRPT SIM co-administration treatment and patients in the co-administration group will crossover to the ERN/LRPT/SIM placebo combination treatment for another 8 weeks. There will also be a period of time when all patients receive placebo.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0207

• Date of REC Opinion

  29 Jul 2011

• REC opinion

  Further Information Favourable Opinion