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    Summary
    EudraCT Number:2009-012451-18
    Sponsor's Protocol Code Number:CRO1202
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-14
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-012451-18
    A.3Full title of the trial
    EUROACTION PLUS: Intensive smoking intervention (Varenicline) during a preventive cardiology programme for patients with established atherosclerotic disease, people at high cariovascular risk and their families
    A.3.2Name or abbreviated title of the trial where available
    EUROACTION PLUS INTENSIVE SMOKING INTERVENTION (VARENICLINE)
    A.4.1Sponsor's protocol code numberCRO1202
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorImperial College London
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Champix
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameChampix
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVarenicline Tartrate
    D.3.9.1CAS number 249296-44-4
    D.3.9.3Other descriptive name7,8,9,10-tetrahydro-6,10-methano-6H-Pyrazino (2,3-h)(3) benzazepine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 mg
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVarenicline Tartrate
    D.3.9.1CAS number 249296-44-4
    D.3.9.3Other descriptive name7,8,9,10-tetrahydro-6,10-methano-6H-Pyrazino (2,3-h)(3) benzazepine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5 mg
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Current cigarette smokers with coronary or other atherosclerotic disease or people at high risk of developing cardiovascular disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Level LLT
    E.1.2Classification code 10053325
    E.1.2Term Smoking cessation therapy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate whether VARENICLINE prescribed to patients enrolled to a preventive cardiology programme can achieve faster, more effective smoking cessation in patients with coronary or other atherosclerotic disease, people at high cardiovascular risk and their partners in every day clinical practice.
    E.2.2Secondary objectives of the trial
    Secondary research questions:

    (i) Number of smoking relapses in intervention and usual care. Smoking relapse is defined as to “the time to last cigarette from the start of Varenicline”
    (ii) Compliance with varenicline and all other drug therapies.
    (iii) Mean number of cigarettes being smoked at baseline and 16 weeks (in those who are continuing smoking).
    (iv) Side effects of varenicline
    (v) Proportions of patients in whom varenicline is withdrawn and the medical reasons given.
    (vi) Proportions of patients achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention:
    a) smoking habit (self reported, breath carbon monoxide {CO}, Fagerstrom Test for Nicotine Dependence (FTND))
    b) diet/ nutrition (self reported, food habit questionnaire)
    c) physical activity (self reported, step counter, Chester step test, DASI physical activity questionnaire)
    d) overweight/ obesity (body mass index (BMI), waist circumference)
    e) diab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Vascular patients and partners

    All patients, men and women 18 years of age or older but less than 80 years, with a new or recurrent diagnosis of coronary or other atherosclerotic vascular disease, and who are continuing to smoke, will be eligible for the programme.
    Patients may fulfill more than one of thefollowing criteria:
    1) Acute myocardial infarction (STEMI or NSTEMI)
    2) Unstable angina
    3) Stable angina pectoris
    4) Elective revascularisation:
    - coronary artery by-pass graft (CABG)
    - percutaneus transluminal angioplasty (PTCA)
    5)Stroke
    6)Transient iscaemic attack (TIA)
    7)Peripheral vascular disease (PVD)

    The partners of all recruited vascular patients will also be identified and invited to participate in the programme.

    2. High-risk patients and partners

    All high risk people who meet the following inclusion criteria: Men and women, 50 years of age or older, but less than 80 years, who are smokers and either
    1) are newly identified high multifactorial risk individuals: CVD risk equal or greater than 5% over 10 years (now or projected to age 60 years), according to the HeartScore risk estimation system; or
    2) have been treated with antihypertensive and/or lipid-lowering therapies in the last year; or
    3) have diabetes mellitus diagnosed within the last 3 years.

    The partners of all recruited high risk patients will also be identified and invited to participate in the programme.

    E.4Principal exclusion criteria
    Vascular patients:
    - severe heart failure
    - severe physical disability
    - impaired cognitive function
    - patients with acute coronary syndromes, with or without revasularisation, will not be included in the study until 2 weeks has elapsed following their coronary event.

    High risk people:
    - history of coronary heart disease
    - severe heart failure
    - severe physical disability
    - impaired cognitive function
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study will be the 7-day point (period)
    prevalence of non-smoking at 16 weeks . The smoking cessation will be validated by breath CO < 10 ppm. Patients will be classified as non-smokers if they are not smoking in the week prior to their 16 week assessment even if they have relapsed several times in the intervening period. If they are smoking in that same week, and/or breath CO is raised, they will be classified as smokers. The primary endpoint is the prevalence of non-smokers in intervention compared to usual care.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    usual care
    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 EEA5
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    Completed 16 week assessment of all patients and partners participated in the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state212
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1060
    F.4.2.2In the whole clinical trial 1060
    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)
    Patients will be refered to their GPs for a follow-up and appropriate action with regard to lifestyle, risk factor and therapeutic management.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-31
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