Assessment of the lipid lowering agents on plasma homocysteine concentration and renal function

ISRCTN	ISRCTN22151635
DOI	https://doi.org/10.1186/ISRCTN22151635
Protocol serial number	N0211136321
Sponsor	Department of Health
Funder	Royal Surrey County Hospital NHS Trust (UK)

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

Dr Brian Starkey
Scientific

Royal Surrey County Hospital Trust
Egerton Road
Guildford
GU2 5XX
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Assessment of the lipid lowering agents on plasma homocysteine concentration and renal function
Study objectives	Are the benefits of fibrate therapy offset by an increase in plasma homocysteine?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Lipid lowering agents
Primary outcome measure(s)	Measurements of renal function, plasma homocysteine and lipids over an 8-month period
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key inclusion criteria	Adult patients attending the lipid clinic with raised cholesterol and triglycerides
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/11/2003
Date of final enrolment	30/09/2005

Royal Surrey County Hospital Trust

Guildford
GU2 5XX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan