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Trial History Detail on 2006-03-02

CUHK_CCT00098

2006-03-02

Retrospective

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

Dr Francis C.C. Chow

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

Lana Lam

Telephone:26323221,Fax:26492397,email: b200420@cuhk.edu.hk

Telephone,Fax,email.

Dr Risa Ozaki

Telephone:26323221,Fax:26492397,email: b200420@cuhk.edu.hk

Telephone,Fax,email.

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.

Yes

2005-04-19

hyperliipidaemia

Drug

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

24 weeks

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

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. 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

Randomized

Dose comparison

Open label

Parallel

2005-06-18

120

Recruiting

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.

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.

No

2013-01-11


Yes

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