Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00098

2 Trial Registration Date

2006-03-02

i Registration Status

Retrospective

3 Secondary IDs

none

4 Source(s) of Funding

Chinese University of Hong Kong (investigator-initiated study) AstraZeneca Limited

5 Primary Sponsor

Dr Francis C.C. Chow

6 Secondary Sponsor

Dr Risa Ozaki Dr Alice P.S. Kong Dr Wing Yee So Dr Wing Bun Chan Dr Winnie W.Y. Lau Dr Anglea Y.S. Cheng Dr Linda Yu Dr Andrea Luk Dr Dicky Cheung Dr Dr C.Y. Yeung Dr H.K. Pang Dr I.M. Wong

Function

Please specify

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

i Name

Lana Lam

ii Address

3M, Old Block, PWH, N.T.

iii Phone

26323221

iv Email

b200420@cuhk.edu.hk

v Affiliation

3M, Old Block, PWH, N.T.

vi Country

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

i Name

Dr Risa Ozaki

ii Address

3M, Old Block, PWH, N.T.

iii Phone

26323221

iv Email

b200420@cuhk.edu.hk

v Affiliation

none

vi Country

9 Official Scientific Title of the Study

A Randomized, Open-labebeled, Parallel, Comparative Study of the Efficacy and Tolerability of Rosuvastatin in LDL-C Reduction Using Different Dosing Regimes of 5mg Daily, 10mg Daily and 10mg Alternate day in Hong Kong Chinese Type 2 Diabetic Patients.

10 Public Title

A Randomized, Open-labebeled, Parallel, Comparative Study of the Efficacy and Tolerability of Rosuvastatin in LDL-C Reduction Using Different Dosing Regimes of 5mg Daily, 10mg Daily and 10mg Alternate day in Hong Kong Chinese Type 2 Diabetic Patients.

i Public Title in Chinese 研究名稱

none

11 Short Title (Optional)

A Randomized, Open-labebeled, Parallel, Comparative Study of the Efficacy and Tolerability of Rosuvastatin in LDL-C Reduction Using Different Dosing Regimes of 5mg Daily, 10mg Daily and 10mg Alternate

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?

2005-04-19

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

hyperliipidaemia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Drug intervention: rosuvastatin 5 mg daily or 10 mg daily or 10 mg on alternate days

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

24 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Rosuvastatin 10mg alt day is compared with Rosuvastatin 5mg qd and Rosuvastatin 10mg qd.

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

Inclusion criteria: 1. Type 2 diabetic patients 18 to 75 years of age. 2. Treated with diet alone, oral hypoglycemic agents and/or insulin. 3. LDL-Cholesterol >/= 2.6 mmol/l. 4. Dyslipidaemia persisting after diet control for eight weeks or more. 5. Alcohol consumption <50 g/day. 6. Not on treatment with drugs known to interfere with glucose tolerance or drugs that have a major effect on lipid metabolism e.g. thiazide diuretics and beta-blockers. 7. Good compliance to diet and drugs. 8. HbA1c <9% (glucosylated haemoglobin <9%)9. Blood pressure <160/95 mmHg.

ii Exclusion Criteria

Exclusion criteria: 1. Significantly impaired renal function (plasma creatinine >150 micromol. 2. Impaired liver function (Serum Glutamic Pyruvic Transaminase [SGPT] or alanine aminotransferase [ALT] twice the upper limit of normal). 3. Secondary dyslipidaemia, diabetic dyslipidaemia. 4. Pregnant women or those planning a pregnancy. 5. Lactation. 6. Progressive fatal disease. 7. History of drug or alcohol abuse. 8. History of hypersensitivity to study medication or drugs with a similar chemical structure. 9. Likelihood of requiring treatment during the study period with the following drugs: cyclosporine, erythromycin

iii Age Minimum

18

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-06-18

21 Target Sample Size

120

22 Recruitment Status

Complete

23 Primary Outcome

Percentage change of LDL-Cholesterol at 12 weeks and 24 weeks from baseline parameter in the three study arms using different dosing regimes of rosuvastatin.

24 Secondary Outcome

1. Percentage change of total cholesterol, triglyceride levels and High-Density Lipoprotein-Cholesterol (HDL-C) at 12 weeks and 24 weeks from baseline parameters in the three study arms using different dosing regimes of rosuvastatin. 2. Effects on glycemic control as determined by fasting glucose and HbA1c at 12 weeks and 24 weeks. 3. Effects on insulin resistance as determined by Homeostasis Model Assessment (HOMA) at 12 and 24 weeks. 4. Effects on urinary albumin excretion and creatinine clearance as assessed at 12 and 24 weeks.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-01-11

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-06000677

28 Date of Registration in Primary Registry

2010-05-04

Back History

Trial Detail