Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00354

2 Trial Registration Date

2013-01-19

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

CUHK

5 Primary Sponsor

CUHK

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Benny Fok

ii Address

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

iii Phone

(852) 2632-3377

iv Email

bfok@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Brian Tomlinson

ii Address

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

iii Phone

(852) 2632-3139

iv Email

btomlinson@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

Effect of probucol on cardiovascular risk in FH

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-07-30

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Hypercholesterolaemia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Probucol 500mg

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Twice daily, up to 24 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i 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.

ii 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.

iii Age Minimum

18

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-03-15

21 Target Sample Size

30

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

% change in lipid profiles

24 Secondary Outcome

% 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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-02-20

27 Primary Registry and Trial Identifying Number

ChiCTR-ONC-13003008

28 Date of Registration in Primary Registry

2013-01-19

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

n/a

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Trial History Detail on 2013-04-26