Contact information
Type
Scientific
Primary contact
Dr Jacob George
ORCID ID
Contact details
Department of Clinical Pharmacology
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 660111 ext 33176
j.george@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
242/03
Study information
Scientific title
Acronym
GEO 001
Study hypothesis
High dose (600 mg) allopurinol improves endothelial function significantly more than the regular 300 mg dose
Ethics approval
Ethics ref no: 242/03 (application is retrospective, trial is already complete and ethics approval was gained)
Study design
Randomised, placebo-controlled, double blind, crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic Heart Failure
Intervention
Allopurinol 300 mg versus allopurinol 600 mg versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Allopurinol
Primary outcome measure
Improvement in endothelial function
Secondary outcome measures
Urate levels and oxidative stress burden
Overall trial start date
05/02/2004
Overall trial end date
29/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Three-month period free of hospitalisations prior to screening
2. Ability to give written informed consent to participate in the study
3. Diagnosis of mild to moderate chronic heart failure
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. History of drug sensitivity or allergy to allopurinol or vitamin C
2. Current treatment with allopurinol , theophylline or cytotoxic drugs (including azothiaprine or mercaptopurine)
3. History of acute gout
4. Evidence of significant disease that could impair absorption, metabolism or excretion of orally administered medication i.e.
a. Renal disease (serum creatinine >160 umol/l)
b. Clinically significant hepatic disease (either by lab work, i.e. alanine aminotranferease (ALT) and aspartate aminotransferase (AST) (ALT/AST > 3 times upper limit of normal, or by clinical assessment)
5. Any condition with sufficient severity to impair co-operation in the study
6. History of chronic alcoholism / intravenous drug abuse
7. Use of another investigational drug within three months of entry into the study or within five half-lives of the investigational drug (the longer time period applying)
8. Pregnancy, breast feeding or being of childbearing age and not taking oral contraceptives
Recruitment start date
05/02/2004
Recruitment end date
29/08/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
Research and Innovation Services
University of Dundee
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 344664
research@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation funded project PG 03/060
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
Basic results (scientific)
Publication list
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17130343
Publication citations
-
Results
George J, Carr E, Davies J, Belch JJ, Struthers A, High-dose allopurinol improves endothelial function by profoundly reducing vascular oxidative stress and not by lowering uric acid., Circulation, 2006, 114, 23, 2508-2516, doi: 10.1161/CIRCULATIONAHA.106.651117.