drugset / Trial / NCT01052311

The Impact of Tredaptive on Flow-Mediated Dilation in Cardiac Patients

NCT01052311

Phase 4 Terminated 8 enrolled Sheba Medical Center
RandomizedParallel-groupDouble-blindTreatment

Summary

Laropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) offers improved tolerability, supporting a simplified 1-2 g dosing paradigm and improved adherence. Statins and niacin improve endothelial function in cardiac patients, however, there is no data yet regarding the additive effects of raising HDL-C by ERN/LRPT and statins on endothelial function in cardiac patients. Thus the aim of the present study is to evaluate the impact of 3 months' administration of ERN/LRPT compared to placebo added to statins on endothelial function, assessed by brachial artery vasoreactivity in stable cardiac patients.

Timeline

Start
2010-07
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Niacin Small molecule 2 g
Comparator laropiprant Small molecule 20 mg