drugset / Trial / NCT01514461

A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome

NCT01514461

Phase 3 Completed 45 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia \[HLP\] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1).

Timeline

Start
2012-07
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Pradigastat Small molecule 20 mg
Subject Pradigastat Small molecule 40 mg