Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Alternate day dosing of rosuvastatin 10 mg is comparable to daily dosing of rosuvastatin 5 mg
Ethics approval
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
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
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Dyslipidaemia
Intervention
Drug intervention: rosuvastatin 5 mg daily or 10 mg daily or 10 mg on alternate days
Intervention type
Drug
Phase
Not Specified
Drug names
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 trial start date
18/06/2005
Overall trial end date
18/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
18/06/2005
Recruitment end date
18/12/2006
Locations
Countries of recruitment
Hong Kong
Trial participating centre
Flat 8A
Shatin, New Territories
-
Hong Kong
Funders
Funder type
University/education
Funder name
Chinese University of Hong Kong (investigator-initiated study)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list