Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0211136321
Study information
Scientific title
Assessment of the lipid lowering agents on plasma homocysteine concentration and renal function
Acronym
Study hypothesis
Are the benefits of fibrate therapy offset by an increase in plasma homocysteine?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular: Hyperlipidemia
Intervention
3 groups:
1. Group 1 = Fibrate 1
2. Group 2 = Fibrate 2
3. Group 3 = Statin (Control)
Intervention type
Drug
Phase
Not Applicable
Drug names
Lipid lowering agents
Primary outcome measures
Measurements of renal function, plasma homocysteine and lipids over an 8-month period
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2003
Overall trial end date
30/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients attending the lipid clinic with raised cholesterol and triglycerides
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2003
Recruitment end date
30/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Surrey County Hospital Trust
Guildford
GU2 5XX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Surrey County Hospital NHS Trust (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