drugset / Trial / NCT01321034

Effect of Niacin in the Lipoprotein (a) Concentration

NCT01321034

NaSingle-groupOpen-labelTreatment

Summary

Objectives. * To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant in subjects with normal Lp(a) (\< 30 mg/dL), high Lp(a) (30-60 mg/dL) and very high Lp(a) (\> 60 mg/dL). * To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant depending on the number of kringle IV-2 repeated copies on the apo(a) gene. 2.1.1 Hypotheses. * The Lp(a) lowering effect of niacin is dependent of the pre-treatment Lp(a) concentration, with higher absolute and relative reduction in Lp(a) in subjects with hyperlipoproteinemia(a). * Lp(a) size, throughout modifying hepatic synthesis of apo(a), is a major factor related to the lowering effect variability of niacin in human.

Timeline

Start
2011-10
Primary completion
2012-08
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Niacin Small molecule 2 g
Subject laropiprant Small molecule 40 mg

Indications