Hypercholesterolaemia
Conditions
Interventions
One cohort:Probucol 500mg twice daily for 24 weeks
Sponsors
Chinese University of Hong Kong
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Chinese patients with heterozygous FH; patient has elevated LDL-C of >=2.6 mmol/L or >=1.8 mmol/L for those patients with very high cardiovascular risk or with xanthelasma with or without lipid-lowering treatment; having tendon xanthomas or xanthelasma is favourable but not essential.
Exclusion criteria
Exclusion criteria: History of hypersensitivity to any of the ingredients contained in the study drug; pregnancy or breast-feeding; severe ventricular arrhythmias or abnormal ECG at baseline; patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate; patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study; patient has history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of screening; elevated liver enzymes (ALT > 1.5 x ULN) or renal impairment (plasma creatinine > 200 µmol/L) or uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins; participation in an investigational drug study within 2 months prior to screening; history of alcohol or drug abuse; concomitant drugs that will be excluded at study entry include: niacin or fibrate initiated or adjusted within 6 weeks prior to screening; statin or ezetimibe initiated or adjusted within 4 weeks prior to screening; weight lowering agents with 6 months prior to screening; systemic corticosteroids within 4 weeks prior to screening; patient currently engages in, or during the study plans to engage, in vigorous exercise or an aggressive diet regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in lipid profile; | — |
Secondary
| Measure | Time frame |
|---|---|
| glucose;insulin;CETP;hsCRP;other cardiovascular biomarkers;regression of tendon xanthomas and/or xanthelasm; | — |
Countries
China
Contacts
Public ContactBrian Tomlinson
Outcome results
None listed