EFFECT-FD: Effect of adding bezaFibrate to standard lipid lowering therapy on non-Fasting CholesTerol in patients with Familial
|- candidate number||22335|
|- NTR Number||NTR5227|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-jun-2015|
|- Secondary IDs||EudraCT number 2014-000524-26|
|- Public Title||EFFECT-FD: Effect of adding bezaFibrate to standard lipid lowering therapy on non-Fasting CholesTerol in patients with Familial
|- Scientific Title||A randomized, double blind, cross-over trial to study the effects of adding
bezafibrate to standard lipid lowering therapy on postprandial lipids in
patients with familial dysbetalipoproteinemia|
|- hypothesis||Bezafibrate will significantly reduce post-prandial non-HDL cholesterol in patients with Familial
Dysbetalipoproteinemia compared to placebo.|
|- Healt Condition(s) or Problem(s) studied||Familial Dysbetalipoproteinemia|
|- Inclusion criteria||1. Presence of a genetically confirmed apolipoprotein E2 homozygote
genotype or an autosomal dominant FD genotype in combination with (at
least) one of the following clinical characteristics:|
o (History of) presence of xanthoma;
o ApoB/TC ratio <0.15 or;
o Use of lipid-lowering medication.
2. Age >18 years (on the day of signing informed consent). Both males and
females will be included.
3. Women are postmenopausal and not receiving hormone therapy.
4. Any type of lipid lowering treatment, including lifestyle.
|- Exclusion criteria||o Use of any type of fibrate (including but not limited to gemfibrozil,
bezafibrate, fenofibrate and ciprofibrate);|
o Intolerance, known allergy or hypersensitivity to fibrate or any component of the medication;
o Unable to drink oral fatload;
o History of cholelithiasis or other biliary diseases;
o History of rhabdomyolysis;
o History of organ transplantation and/or immunosuppressive medication;
o Uncontrolled diabetes mellitus: HbA1c >69 mmol/mol;
o Untreated (sub)clinical hypothyroidism: defined as TSH ¡Ý5.0 mcIU/mL;
o Impaired renal function (estimated glomerular filtration rate (eGFR) <60
mL/min/1.73m2 based on MDRD equation at the screening visit), need of hemodialysis or other clinically significant renal disease;
o Active liver disease or impaired liver function (AST/ALT >1.5x ULN);
o Creatinine kinase (CK) >3 x ULN;
o Poorly controlled blood pressure with systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg at the screening visit;
o Active malignancy (¡Ü 2 year prior to informed consent);
o Human Immunodeficiency Virus (HIV) or AIDS;
o Celiac disease or other disorder associated with significant intestinal
o Alcohol abuse/excessive alcohol use, defined as >14 alcoholic consumptions per week.
o Use of anti-tuberculosis medication;
o Use of anti-epileptics;
o Use of oral anticoagulants;
o Use of monoamine oxidase (MAO) inhibitors (antidepressant);
o Use of cytochrome P450 3A4 (CYP3A4) inhibitors: oral antimycotics (fluconazol, itraconazol, ketoconazole, voriconazol, posaconazol), ciclosporin, grapefruit juice, mycines (azithromycin, clarithromycin, erythromycin), diltiazem, verapamil and amiodaron;
o Galactose-intolerance, Lapp-lactose deficiency or glucose-galactose
o Current participation or participation in a study with an investigational compound or device within 30 days of signing informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2015|
|- planned closingdate||1-jul-2016|
|- Target number of participants||20|
|- Interventions||Bezafibrate 400mg, tablet, once daily for 6 weeks.|
|- Primary outcome||Post fatload non-HDL cholesterol.|
|- Secondary outcome||1. Post fat load TC, HDL-C, LDL-C, TG, apoB, CRP, glucose, insulin, adipocytokines and markers of inflammation.|
2. Fasting non-HDL cholesterol.
3. Fasting TC, HDL-C, LDL-C, TG, apoB, CRP, glucose, insulin, adipocytokines and markers of inflammation.
4. Safety of bezafibrate.
|- Timepoints||Difference between Bezafibrate and placebo in post fatload non-HDL-C after a treatment period of 6 weeks. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Charlotte Koopal|
|- CONTACT for SCIENTIFIC QUERIES|| Frank Visseren|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Vrienden van UMC Utrecht|
|- Brief summary||Randomized, double blind, cross-over trial in 20 patients with Familial Dysbetalipoproteinemia using standard lipid-lowering therapy. The study consists of two 6-week treatment periods, with a 2 week crossover periode in between, in which patients receive Bezafibrate 400mg daily or placebo in a random order. Primary endpoint is difference between bezafibrate and placebo in postprandial non-HDL cholesterol after an oral fatload. Other endpoints are: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, apoB, CRP, glucose, insulin, adipocytokines and markers of inflammation.|
|- Main changes (audit trail)|
|- RECORD||12-jun-2015 - 30-jul-2015|
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