Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00352

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

Pharmacokinetic interaction between rosuvastatin and telmisartan

10 Public Title

Pharmacokinetic interaction between rosuvastatin and telmisartan

i Public Title in Chinese 研究名稱

他汀類藥物與替米沙坦藥物代謝動力學相互作用的研究

11 Short Title (Optional)

Rosuvastatin-telmisartan interactions

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?

2012-10-15

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Hyperlipidaemia, hypertension

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Rosuvastatin 10mg/ Telmisartan 40mg

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Rosuvastatin (2 days)/ Telmisartan (14 days)

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

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.

ii Exclusion Criteria

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).

iii Age Minimum

18

iv Age Maximum

70

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Historical control

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

2013-03-18

21 Target Sample Size

24

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Differences in statin pharmacokinetic parameters with and without telmisartan

24 Secondary Outcome

Difference in pharmacokinetic parameters and interactions among genotype groups

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-13003006

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