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Trial History Detail on 2014-02-20

CUHK_CCT00352

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

Pharmacokinetic interaction between rosuvastatin and telmisartan

Pharmacokinetic interaction between rosuvastatin and telmisartan

他汀類藥物與替米沙坦藥物代謝動力學相互作用的研究

Rosuvastatin-telmisartan interactions

Hong Kong

Yes

2012-10-15

Hyperlipidaemia, hypertension

Drug

Rosuvastatin 10mg/ Telmisartan 40mg

Rosuvastatin (2 days)/ Telmisartan (14 days)

Nil

Body mass index : 18-30 kg/m2; treatment with rosuvastatin 10 mg daily with or without other lipid-modifying drugs for at least for 4 weeks according to the current HA guidelines; borderline high or high blood pressure (systolic blood pressure ≥120 mmHg or diastolic blood pressure ≥ 80 mmHg) with or without anti-hypertensive treatment other than angiotensin-converting enzyme inhibitors (ACEIs) or ARBs.

History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study; clinically significant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test or upon Investigator decision; adjustment of lipid-lowering treatment within 6 weeks prior to the study in patients with hyperlipidaemia; treatment of telmisartan or other ARBs or ACEIs within 4 weeks prior to the study; adjustment of concomitant medications within 4 weeks prior to the study; taking other drugs known to interact with rosuvastatin or telmisartan; volunteer in any clinical drug study within 2 months prior to this study; history of allergy or hypersensitivity to rosuvastatin or telmisartan; type 2 diabetes with poor glyceamic control (HbA1c> 8.5%); impaired hepatic or renal disease function (alanine aminotransferase [ALT] >1.5 times upper limit of normal range; serum creatinine > 140 mol/L); regular heavy alcohol consumption (>21 units of alcohol per week).

18

70

Both Male and Female

Interventional

Non-randomized

Historical control

Open label

Single group

2013-03-18

24

Unknown

Differences in statin pharmacokinetic parameters with and without telmisartan

Difference in pharmacokinetic parameters and interactions among genotype groups

No

2014-02-20

ChiCTR-ONC-13003006

2013-01-19


Yes

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