MK-0524B in Mixed Hyperlipidaemia

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of MK-0524B (dosed as coadministered MK-0524A and Simvastatin Tablets) Versus Atorvastatin in Patients With Mixed Hyperlipidemia

• Contact name

  Paul Robinson

• Sponsor organisation

  Merck & Co

• Eudract number

  2007-000037-19

• Clinicaltrials.gov Identifier

  NCT00289900

• Research summary

  This clinical study is designed to compare the lipid-altering effects of MK-0524B (niacin/laropiprant/simvastatin in fixed-dose combination) against those of atorvastatin over a range of doses. After a suitable wash-out period of lipid-altering drugs, and a run-in period, eligible participants will allocated to one of four treatment groups: MK-0524B, atorvastatin 20mg daily, atorvastatin 40mg daily or atorvastatin 80 mg daily, for 12 weeks. Efficacy will be determined through lipid profiling throughout the study, and saftey will be assessed through records of adverse events, blood pressure and pulse and clinical safety laboratory assessment.

• REC name

  London - South East Research Ethics Committee

• REC reference

  08/H1102/96

• Date of REC Opinion

  19 Nov 2008

• REC opinion

  Further Information Favourable Opinion