The effect of bezafibrate on cholesterol levels after an oral fatload in patients with Familial Dysbetalipoproteinemia

A randomized, placebo-controlled, 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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000524-26-NL

Enrollment

Unknown

Registered

2015-04-08

Start date

2015-05-19

Completion date

Unknown

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Dysbetalipoproteinemia

Interventions

Trade Name: Bezalip retard 400 mg (bezafibrate) Product Name: Bezafibrate Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age >18 - clinical diagnosis of Familial Dysbetalipoproteinemia with genetic confirmation - women are postmenopausal Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - fibrate use - sensitivity/allergy to fibrates - history of galbladder disease - history of rhabdomyolisis - eGFR 3*ULN

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Difference in incremental area under the curve between bezafibrate and placebo from several metabolic markers (TC, TG, LDL-c, apoB, insulin, glucose, CRP). Difference in fasting values between bezafibrate and placebo from several metabolic markers (non-HDL, TC, TG, LDL-c, apoB, insulin, glucose, CRP). Number and nature of reported side effects;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment (2 week cross-over between treatment periods)	—

Measure

Time frame

Secondary end point(s): Difference in incremental area under the curve between bezafibrate and placebo from several metabolic markers (TC, TG, LDL-c, apoB, insulin, glucose, CRP). Difference in fasting values between bezafibrate and placebo from several metabolic markers (non-HDL, TC, TG, LDL-c, apoB, insulin, glucose, CRP). Number and nature of reported side effects;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment (2 week cross-over between treatment periods)

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Primary

Measure	Time frame
Secondary Objective: Evaluation of other postprandial lipds and metabolic markers (TC, TG, LDL-C, ApoB, glucose, insulin and CRP) after treatment with bezafibrate versus placebo. Evaluation of fasting lipds and metabolic markers (non-HDL, TC, TG, LDL-C, ApoB, glucose, insulin and CRP) after treatment with bezafibrate versus placebo. Evaluation of side effects of Bezafibrate;Primary end point(s): difference in non-HDL cholesterol incremental area under the curve between bezafibrate and placebo;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment (2 week cross-over between treatment periods);Main Objective: Evaluation of postprandial non-HDL cholesterol after treatment with bezafibrate versus placebo on top of standard lipid lowering therapy.	—

Measure

Time frame

Secondary Objective: Evaluation of other postprandial lipds and metabolic markers (TC, TG, LDL-C, ApoB, glucose, insulin and CRP) after treatment with bezafibrate versus placebo. Evaluation of fasting lipds and metabolic markers (non-HDL, TC, TG, LDL-C, ApoB, glucose, insulin and CRP) after treatment with bezafibrate versus placebo. Evaluation of side effects of Bezafibrate;Primary end point(s): difference in non-HDL cholesterol incremental area under the curve between bezafibrate and placebo;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment (2 week cross-over between treatment periods);Main Objective: Evaluation of postprandial non-HDL cholesterol after treatment with bezafibrate versus placebo on top of standard lipid lowering therapy.

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Countries

Netherlands

Contacts

Public ContactFrank LJ Visseren

University Medical Center Utrecht

F.L.J.Visseren@umcutrecht.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026