TerminatedPhase 3

Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome.

Stopped: Interim analysis suggested that size of benefit anticipated from continued participation of patients in Part B no longer supported trial extension beyond Part A

United States, Canada, France38 participantsStarted 2013-02

Plain-language summary

This study was to determine long-term safety and tolerability, and continued efficacy in lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS) (HLP type I).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent must be obtained before any assessment is performed.
✓. Subjects that either discontinue prematurely or complete the CLCQ908B2302 study after 52 weeks or FCS subjects who have previously completed study CLCQ908A2212.

Exclusion criteria

✕. Subjects discontinued from the CLCQ908B2302 study for serious, potentially study drug related adverse events.
✕. Subjects from the CLCQ908B2302 study who have developed any other contraindication to participation (for example, renal failure)
✕. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
✕. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
✕. Subjects with type 1 diabetes mellitus or type 2 diabetes mellitus if HbA1C is ≥ 8.5%.
✕. Treatment with fish oil preparations within 4 weeks prior to randomization.
✕. Treatment with bile acid binding resins (i.e., colesevelam, etc) within 4 weeks prior to randomization.
✕. Treatment with fibrates within 8 weeks prior to randomization. Washout may occur following screening if required.

What they're measuring

Number of Patients With Any Adverse Events, Serious Adverse Events and Death

Timeframe: 52 weeks

Trial details

NCT IDNCT01589237

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07

Results submitted2016-06-17

View on ClinicalTrials.gov More Familial Chylomicronemia Syndrome (FCS) (HLP Type I) trials