Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT000255
Study information
Scientific title
Acronym
Study hypothesis
That treatment with atorvastatin will lead to improvement in monocyte phenotype in individuals at risk of cardiovasular disease
Ethics approval
HPSS REC3, one of the Research Ethics Committees of Northern Ireland, on the 2nd August 2006 (ref: 06/NIR03/79).
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Metabolic syndrome
Intervention
Treatment with atorvastatin 10 mg per day versus placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Atorvastatin
Primary outcome measures
Measurement of monocyte response to chemotaxins in vitro (the chemotactic index)
Secondary outcome measures
Measurement of expression of other molecules (e.g. cell adhesion molecules) involved in atherosclerosis in serum, monocytes and human endothelial cells exposed to patient serum
Overall trial start date
01/08/2006
Overall trial end date
31/07/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 35 - 63 years
2. Metabolic syndrome as defined by the International Diabetes Federation, central obesity plus two of the following:
2.1. Hypertension
2.2. Glucose intolerance
2.3. Low levels of high-density lipoprotein cholesterol (HDL-C)
2.4. Hypertriglyceridemia
Control subjects must have none of these features.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Pre-existing indication for lipid-lowering therapy, or history of intolerance of these agents
2. Use of insulin or hormone replacement therapy
3. History of liver or muscle disease
4. Impaired renal function
5. Potential for pregnancy (females)
6. Total cholesterol greater than 6.5 mmol/l or less than 4 mmol/l
Recruitment start date
01/08/2006
Recruitment end date
31/07/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Clinical Biochemistry
Belfast
BT12 6BA
United Kingdom
Funders
Funder type
Government
Funder name
The Northern Ireland Research and Development Office (UK)
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