Condition category
Circulatory System
Date applied
13/01/2006
Date assigned
01/03/2006
Last edited
01/03/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francis C.C. Chow

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Chinese University of Hong Kong

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes