EUCTR2011-001883-23-GBActive, not recruitingPhase 1
FAST- Febuxostat versus Allopurinol Streamlined Trial A prospective, randomised, open-label, blinded endpoint (PROBE) clinical trial evaluating long term cardiovascular safety of febuxostat in comparison with allopurinol in patients with chronic symptomatic hyperuricaemia - FAST- Febuxostat versus Allopurinol Streamlined Trial V 11.0
niversity of Dundee0 sites5,706 target enrollmentStarted: July 18, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 5,706
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or female patients aged 60 years or over with a least one additional risk factor. *Risk Factors Age =70 years (male) or =75 years (female) Smoking (current or within the last 2 years) Diabetes mellitus Impaired glucose tolerance Hypertension (SBP > 140mmHg and/or DBP > 90mmHg) or on antihypertensive therapy Dyslipidaemia (investigator opinion) CKD Stage 1-3 Microalbuminuria or proteinuria Family history of coronary heart disease or stroke in first degree relative at age <55 years Inflammatory arthritis (investigator opinion – including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) Chronic NSAID therapy (investigator opinion) Peripheral vascular disease Previous CV event (MI CVA or transient ischaemic attack) Peripheral vascular disease (Investigator / clinical opinion) Chronic obstructive pulmonary disease (COPD) 2. Patients who, in the opinion of the recruiting physician, require treatment for chronic hyperuricaemia where urate deposition has already occurred. 3. Patients who have received =90 days treatment with allopurinol, or =3 allopurinol prescriptions, within the previous 6 months. 4. Patients, who in the opinion of the study recruiting physician or site coordinator, are eligible for treatment with either allopurinol or febuxostat. 5. Patients who are willing to give permission for their paper and electronic medical records, hospitalisation data, prescribing data, and (in the event of their death) their death certification data to be accessed and abstracted by trial investigators. 6. Patients who are willing to be contacted and interviewed by trial investigators or delegates (suitably trained research nurses), should the need arise (e.g., for adverse event assessment and to determine whether an episode of acute gout has occurred).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3804
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1902
Exclusion Criteria
- •1. Patients who have any contraindication to febuxostat or allopurinol (with reference to the summary of product characteristics). 2. Patients with severe renal impairment (eGFR <30 ml/min as defined by the Cockroft-Gault formula according to creatinine, age, sex and body weight. 3. Patients with moderate or severe hepatic impairment i.e. cirrhosis with clinical and/or biological decompensation (i.e. ascitis, lower limb oedema, icterus or increased prothrombin time >2X reference value) 4. Patients with a life-threatening co-morbidity or with a significant medical condition and/or conditions that would interfere with the treatment, safety or compliance with the protocol. 5. Patients with malignancy, including haematological malignancy. 6. Patients who have experienced either a myocardial infarction or stroke. 7. Patients whose behaviour or lifestyle would render them less likely to comply with study medication (i.e., abuse of alcohol, substance misuse, debilitating psychiatric conditions or inability to provide informed consent). 8. Patients with an acute gout flare or who are within 14 days of the resolution of a gout flare. 9. Patients currently participating in another clinical trial or who have participated in a trial in the previous 3 months.
Investigators
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