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

Phase 1

Conditions: Familial Dysbetalipoproteinemia
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2014-000524-26-NL

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

- fibrate use
- sensitivity/allergy to fibrates
- history of galbladder disease
- history of rhabdomyolisis
- eGFR <60 ml/min/1.73m2
- Impaired liver function
- CK > 3*ULN

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Evaluation of fasting lipds and metabolic markers (non-HDL, TC, TG, LDL-C, ApoB, glucose, insulin and CRP) after treatment with bezafibrate versus placebo.<br>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.

Secondary Outcome Measures

Name	Time	Method
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).<br>Difference in fasting values between bezafibrate and placebo from several metabolic markers (non-HDL, TC, TG, LDL-c, apoB, insulin, glucose, CRP).<br>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)