Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00268

2 Trial Registration Date

2010-06-30

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Merck Sharp & Dohme Corp.

5 Primary Sponsor

Investigator initiated study sponsored by Merck Sharp & Dohme Corp.

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Benny Fok

ii Address

Flat B, Staff Quarters Block B, Prince of Wales Hospital, N.T., 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

Prof. Brian Tomlinson

ii Address

Department of Medicine and Therapeutics

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

Pharmacogenomics of nicotinic acid with laropiprant in Hong Kong Chinese patients with dyslipidemia

10 Public Title

Pharmacogenomics of nicotinic acid with laropiprant in Hong Kong Chinese patients with dyslipidemia

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Pharmacogenomics of nicotinic acid with laropiprant

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?

2010-04-08

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Dyslipidemia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

TREDAPTIVE® (ER nicotinic acid 1g/ laropiprant 20mg)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 week

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

1. Patient is male or female between 18 and 85 years of age on day of signing informed consent.
2. Patient has combined dyslipidemia (type II a and IIb according to Frederickson) and primary hypercholesterolemia (heterozygous familial or non-familial) or who are indicated for TREDAPTIVE treatment according to the nationally labeled indication of TREDAPTIVE with or without HMG-CoA reductase inhibitors (statins).
3. If plasma lipids, renal and liver function tests have not been performed in the preceding 6 weeks prior to dosing with ER niacin/laropiprant, these tests will be performed to determine if the patient is eligible to enter the study.

ii Exclusion Criteria

1. Patient has a history of hypersensitivity to the active substances or to any of the excipients.
2. Patient has significant or unexplained hepatic dysfunction.
3. Patient has active peptic ulcer disease.
4. Patient has significant or unexplained renal dysfunction.
5. Patient consumes more than 2 alcoholic beverages per day.
6. Participation in an investigational drug study within 2 months prior to screening
7. Patient is pregnant or breast-feeding during the study. Women of child-bearing potential will be requested to use an effective means of contraception during the course of the study.
8. Patient is currently experiencing menopausal hot flashes.
9. 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 study, or is not in the best interest of the patient to participate.
10. Concomitant drugs that will be excluded at study entry include: niacin ≥ 50 mg⁄ day; a fibrate taken concomitantly with a statin; lipid-modifying therapy initiated within 6 weeks of the study; cyclical hormonal contraceptives or intermittent use of hormone replacement therapies; systemic corticosteroids; aspirin > 100 mg⁄ day or long-acting NSAIDs; or high-dose antioxidant vitamins.

iii Age Minimum

18

iv Age Maximum

85

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

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

2010-08-01

21 Target Sample Size

400

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Genotype distribution in patients with or without flushing for common polymorphisms in GRP109A and PTGDR after recruitment of at least 400 subjects

24 Secondary Outcome

Nil

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-01-24

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2010-06-30