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Trial History Detail on 2014-02-20

CUHK_CCT00354

2013-01-19

Prospective

Nil

CUHK

CUHK

N/A

Benny Fok

Flat B, 6/F, Block B, Staff Quarters, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

(852) 2632-3377

bfok@cuhk.edu.hk

The Chinese University of Hong Kong

Brian Tomlinson

Department of Medicine and Therapeutics, 9/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

(852) 2632-3139

btomlinson@cuhk.edu.hk

The Chinese University of Hong Kong

Effect of probucol on reducing cardiovascular risk factors in Chinese patients with heterozygous familial hypercholesterolaemia

Effect of probucol on reducing cardiovascular risk factors in Chinese patients with heterozygous familial hypercholesterolaemia

一項評估普羅布考(PROBUCOL)對華裔家族性高膽固醇血症患者降低心血管風險因素的研究

Effect of probucol on cardiovascular risk in FH

Hong Kong

Yes

2012-07-30

Hypercholesterolaemia

Drug

Probucol 500mg

Twice daily, up to 24 weeks

Nil

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.

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.

18

75

Both Male and Female

Interventional

Non-randomized

Uncontrolled

Open label

Single group

2013-03-15

30

Unknown

% change in lipid profiles

% change from baseline to the end of the treatment period will be studied for glucose, insulin, CETP, hsCRP and some other cardiovascular biomarkers; regression of tendon xanthomas and/or xanthelasma

No

2014-02-20

ChiCTR-ONC-13003008

2013-01-19


Yes

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