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    Summary
    EudraCT Number:2011-001883-23
    Sponsor's Protocol Code Number:2011CV08
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2011-001883-23
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Febuxoststat versus Allopurinol Steamlined Trial (FAST)
    A.3.2Name or abbreviated title of the trial where available
    FAST- Febuxostat versus Allopurinol Streamlined Trial V 11.0
    A.4.1Sponsor's protocol code number2011CV08
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN72443728
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Dundee
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMenarini
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Southern Denmark
    B.5.2Functional name of contact pointDept. of clinical pharmacology, SDU
    B.5.3 Address:
    B.5.3.1Street AddressJB Winsløwsvej 19,2
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post codeDK-5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4565503010
    B.5.5Fax number4565916089
    B.5.6E-mailjhallas@health.sdu.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Adenuric
    D.2.1.1.2Name of the Marketing Authorisation holderA. Menarini Manufacturing, Logistics & Services
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFeboxostat Trade Name: Adenuric
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Allopurinol
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini von Heyden
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAllopurinol
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic symptomatic hyperuricaemic
    E.1.1.1Medical condition in easily understood language
    Gout
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10018627
    E.1.2Term Gout
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the cardiovascular safety profile of febuxostat versus allopurinol when taken for an average
    of 3 years in patients over 60 years with chronic hyperuricaemia in conditions where urate deposition has already occurred
    E.2.2Secondary objectives of the trial
    The secondary study objectives are to evaluate other cardiovascular adverse events for both products.
    E.2.3Trial contains a sub-study No
    E.3Principal 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).
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis will be time to event and the endpoint will be the first occurrence of hospitalisation or death due to one or more APTC (Anti-Platelet Trialists’ Collaboration) primary events:
    • non-fatal myocardial infarction
    • non-fatal stroke
    • cardiovascular death
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomisation to first occurence of any event
    E.5.2Secondary end point(s)
    :

    • Hospitalisation for non-fatal MI
    • Hospitalisation for non-fatal stroke
    • Cardiovascular death
    • All cause mortality
    • Hospitalisation for heart failure
    • Hospitalisation for unstable, new or worsening angina
    • Hospitalisation for coronary revascularisation
    • Hospitalisation for cerebral revascularisation
    • Hospitalisation for transient ischeamic attack (TIA)
    • Hospitalisation for non-fatal cardiac arrest
    • Hospitalisation for venous and peripheral arterial vascular thrombotic event
    • Hospitalisation for arrhythmia with no evidence of ischaemia
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints (in rank order of importance) will be evaluated using a time to event analysis
    The following endpoints will be evaluated as an incidence rate:

    • Cardiovascular mortality
    • APTC events in each treatment arm
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Allopurinol
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be determined by the steering committee and this will
    occur when more than the required number of primary endpoints has accrued
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3804
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1902
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1900
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3806
    F.4.2.2In the whole clinical trial 5706
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Study medication will be provided to the participants until the study
    findings are reported (approx 6 months)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-30
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