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

ISRCTN ISRCTN22151635
DOI https://doi.org/10.1186/ISRCTN22151635
Secondary identifying numbers N0211136321
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
17/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
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

Contact information

Dr Brian Starkey
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAssessment of the lipid lowering agents on plasma homocysteine concentration and renal function
Study objectivesAre 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) studiedCardiovascular: Hyperlipidemia
Intervention3 groups:
1. Group 1 = Fibrate 1
2. Group 2 = Fibrate 2
3. Group 3 = Statin (Control)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Lipid lowering agents
Primary outcome measureMeasurements of renal function, plasma homocysteine and lipids over an 8-month period
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/2003
Completion date30/09/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Key inclusion criteriaAdult patients attending the lipid clinic with raised cholesterol and triglycerides
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/2003
Date of final enrolment30/09/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Surrey County Hospital Trust
Guildford
GU2 5XX
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Surrey County Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan