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

Flat 8A
Block B
Staff Quarters
Prince of Wales Hospital
Shatin, New Territories
-
Hong Kong

Study information

Study designRandomized, 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesAlternate 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) studiedDyslipidaemia
InterventionDrug intervention: rosuvastatin 5 mg daily or 10 mg daily or 10 mg on alternate days
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Rosuvastatin
Primary outcome measurePercentage 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 measures1. 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 date18/06/2005
Completion date18/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120
Key inclusion criteria1. 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 criteria1. 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 enrolment18/06/2005
Date of final enrolment18/12/2006

Locations

Countries of recruitment

  • Hong Kong

Study participating centre

Flat 8A
Shatin, New Territories
-
Hong Kong

Sponsor information

Chinese University of Hong Kong
University/education

Flat 8A
Block B
Staff Quarters
Prince of Wales Hospital
Shatin, New Territories
-
Hong Kong

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan