Prospective

Benny Fok

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

(852) 2632-3377

bfok@cuhk.edu.hk

The Chinese University of Hong Kong

Prof. Brian Tomlinson

Department of Medicine and Therapeutics

(852) 2632-3139

btomlinson@cuhk.edu.hk

The Chinese University of Hong KOng

Yes

2010-04-08

Drug

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

1 week

Nil

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.

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.

18

85

Both Male and Female

Randomized

Uncontrolled

Open label

Single group

No

Yes

Nil