Condition category
Circulatory System
Date applied
25/01/2006
Date assigned
27/01/2006
Last edited
16/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17130343

Publication citations

  1. 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.

Additional files

Editorial Notes