CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 45 enrolled
Drug / intervention
LCQ908 +1 moredrug
Likely dose
LCQ908 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01514461
NCT01514461Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Jan 23, 2012·Updated Jun 3, 2015

In Brief

A Phase 3 clinical trial evaluating LCQ908 and Placebo for Familial Chylomicronemia Syndrome (FCS). Completed, enrolled 45 participants across 14 sites in 8 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Chylomicronemia Syndrome (FCS)
CountriesCanada, France, Germany, Netherlands, South Africa, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2012
Enrollment StartJul 1, 2012
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.4 years ago

Interventions

LCQ908drug

LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg

Placebodrug

LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg