MK- 0542B-PN 143 Research study that will test the safety & efficacy of combining extended release niacin + laropiprant + simvastatin (MK-0524B) in the management of cholesterol levels

Mise à jour : Il y a 4 ans
Référence : EUCTR2011-001007-12

Femme et Homme

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Extrait

Evaluate the LDL-C-lowering effects of ERN/LRPT/SIM 2 g/20 mg compared to ERN/LRPT 2 g coadministered with simvastatin 20 mg. Hypothesis: ERN/LRPT/SIM 2 g/20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20 mg in reducing LDL-C. Note: For LDL-C primary hypothesis, the criterion for bioequivalence is that the 95% confidence interval (CI) of the difference in percent change from baseline between the two treatments falls within ±4%.


Critère d'inclusion

  • Primary Hypercholesterolemia & Mixed Dyslipdemia