A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability … (NCT01514461) | Clinical Trial Compass
CompletedPhase 3
A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome
United States, Canada, France45 participantsStarted 2012-07
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent given before any assessment was performed for Period I.
✓. Male and female patients ages at least 18 years of age.
✓. Fasting triglyceride ≥ 8.4 mmol/L (750 mg/dL) at Screening.
✓. An established diagnosis of FCS (HLP Type I) confirmed through ultracentrifugation or by documented medical history of a fasting triglyceride ≥ 8.4 mmol/L (750 mg/dL) and by documentation of any of the following at Screening or during the Screening Period:
✓. History of pancreatitis.
Exclusion criteria
✕. Current pancreatitis, pancreatitis was required to be inactive for at least 1 week prior to the screening Visit.
✕. 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 4 weeks prior to randomization.
✕. Glybera \[alipogene tiparvovec (AAV1-LPLS447X)\] gene therapy exposure within the two years prior to screening.
✕. 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.
What they're measuring
1
Percent Change in Fasting Triglycerides From Baseline to 12 Weeks
. Any surgical or medical conditions, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study or might significantly alter the absorption, distribution, metabolism or excretion of the study drug.
✕. History of drug or alcohol abuse within the 12 months prior to randomization or evidence of such abuse at screening.