A randomized, open-labelled, parallel, comparative study of the efficacy and tolerability of rosuvastatin in low-density lipoprotein-cholestrol reduction using different dosing regimens of 5 mg daily, 10 mg daily and 10 mg on alternate days in Hong Kong Chinese type 2 diabetic patients
| ISRCTN | ISRCTN72526711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72526711 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/01/2006
- Registration date
- 01/03/2006
- Last edited
- 01/03/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Francis C.C. Chow
Scientific
Scientific
Flat 8A
Block B
Staff Quarters
Prince of Wales Hospital
Shatin, New Territories
-
Hong Kong
Study information
| Study design | Randomized, open-labelled, parallel-group study using rosuvastatin 5 mg daily, 10 mg daily or 10 mg on alternate days in patients with Low-Density Lipoprotein (LDL) Cholesterol >/= 2.6 mmol/l after following a standard lipid lowering diet |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Alternate day dosing of rosuvastatin 10 mg is comparable to daily dosing of rosuvastatin 5 mg |
| Ethics approval(s) | Study protocol, informed consent documents, any addenda or amendments have been reviewed and approved jointly by the Chinese University of Hong Kong, New Territories and the East Cluster Clinical Research Ethics Committee, reference number CRE-2005.095-T |
| Health condition(s) or problem(s) studied | Dyslipidaemia |
| Intervention | Drug intervention: rosuvastatin 5 mg daily or 10 mg daily or 10 mg on alternate days |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rosuvastatin |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 18/06/2005 |
| Completion date | 18/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/06/2005 |
| Date of final enrolment | 18/12/2006 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Flat 8A
Shatin, New Territories
-
Hong Kong
-
Hong Kong
Sponsor information
Chinese University of Hong Kong
University/education
University/education
Flat 8A
Block B
Staff Quarters
Prince of Wales Hospital
Shatin, New Territories
-
Hong Kong
"ROR" |
https://ror.org/00t33hh48 |
|---|
Funders
Funder type
University/education
Chinese University of Hong Kong (investigator-initiated study)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
