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    Summary
    EudraCT Number:2010-021789-31
    Sponsor's Protocol Code Number:A3051139
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-021789-31
    A.3Full title of the trial
    A PHASE 4 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF RE-TREATMENT WITH VARENICLINE IN SUBJECTS WHO ARE CURRENTLY SMOKING, AND WHO HAVE PREVIOUSLY TAKEN VARENICLINE
    A.4.1Sponsor's protocol code numberA3051139
    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 SponsorPfizer Inc.235 East 42nd Street, New York, NY 10017 US
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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.3.4Pharmaceutical 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.3.9.1CAS number 375815-87-5
    D.3.9.3Other descriptive nameVARENICLINE TARTRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 No
    D.3.11.3.2Gene therapy medical product No
    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
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Smoking Cessation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10053325
    E.1.2Term Smoking cessation therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 this study is to compare the efficacy and safety of the re-treatment with varenicline with placebo for smoking cessation for the last 4 weeks of a 12 week treatment period (Continuous Abstinence Rate; CAR 9-12).
    E.2.2Secondary objectives of the trial
    The key secondary objective is to compare the efficacy of varenicline with placebo from Week 9 to the end of the long term non-treatment follow up period to 52 weeks (CAR 9-52). Additional secondary efficacy objectives include:
    • Comparing smoking abstinence at the 24 week timepoint (CAR 9-24) between the varenicline and placebo treatment groups;
    • Comparing the 7-day point prevalence of smoking abstinence at specific timepoints (Weeks 12, 24 and 52) between the varenicline and placebo treatment groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Male or female cigarette smokers, aged 18 years or above, motivated to stop smoking and considered suitable for a smoking cessation attempt.
    2. Subjects must have smoked an average of at least 10 cigarettes (cigarettes only) per day during the past 4 weeks, with an exhaled carbon monoxide (CO) > 10ppm at screening.
    3. Subjects who have previously attempted to stop smoking on at least one occasion with varenicline for a treatment duration of two weeks, with the last varenicline dose taken at least 3 months prior to screening. Subjects may be enrolled irrespective of whether they failed to stop smoking during the previous attempt(s) supported by varenicline, or whether they succeeded but subsequently relapsed.
    4. At least 3 months must have elapsed since the subject's last quit attempt, irrespective of whether the last attempt was pharmacologically supported or not.
    5. Females who are not of childbearing potential (ie, who are surgically sterilized or at least 2 years postmenopausal) and who are not nursing may be included. Females who are of childbearing potential may be included provided that they are not pregnant, not nursing, and meet all of the following criteria:
    • Are instructed and agree to avoid pregnancy through 30 days after the last dose of study medication;
    • Have a negative pregnancy test (β -hCG) at Screening and Baseline and;
    • Agree to use at least one of the birth control methods listed below:- an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (eg, Norplant), or an injectable contraceptive (eg, Depo Provera) for at least 1 month prior to entering the study and will continue its use through at least 30 days after the last dose of study medication or:- a barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study through at least 30 days after the last dose of study medication or abstinence.
    6. Evidence of a personally signed and dated Informed Consent Document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Subjects who have previously experienced an adverse drug reaction that the investigator considers potentially due to varenicline treatment, and of sufficient concern that further exposure to varenicline would be inadvisable.
    2. Subjects with severe chronic obstructive pulmonary disease (COPD), defined as any subject who fulfills any of the following criteria:
    • History of repeated exacerbations of COPD (greater than or equal to 3 in 3 years);
    • Requires systemic corticosteroid maintenance (eg, oral prednisolone) for management of chronic symptoms;
    • Is maintained on oxygen therapy for management of chronic symptoms.
    3. Subjects with a recent (less than 5 years) history of cancer. Subjects with a remote (>5 years) history of cancer may be considered pending discussion with the study clinician. Subjects with cured basal cell or squamous cell carcinoma of the skin are allowed.
    4. Subjects with clinically significant cardiovascular disease in the past 2 months. Examples of clinically significant cardiovascular disease include:
    •Myocardial infarction;
    •Coronary artery bypass graft (CABG);
    •Percutaneous transluminal coronary angioplasty (PTCA);
    •Severe or unstable angina;
    •A serious arrhythmia;
    •Clinically significant ECG conduction abnormalities;
    •Heart failure.
    5.Subjects with clinically significant cerebrovascular disease in the past 2 months. Examples of clinically significant cerebrovascular disease include:
    •Cerebrovascular accident (CVA), stroke;
    •Documented transient ischaemic attack.
    6.Subjects with a history of a suicide attempt or any suicidal behaviour in the past 2 years.
    7.Subjects with suicidal ideation identified by the C-SSRS at the screening or baseline visit.
    8.Subjects with current depression, or who have been diagnosed or treated with antidepressants during the past 12 months.
    9.Subjects with a lifetime diagnosis of psychosis, panic disorder, other anxiety disorders or bipolar disorder.
    10.Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.
    11.Subjects with a positive urine drug screen (at screening or baseline) for drugs of abuse/potential abuse not prescribed for the treatment of a medical condition.
    12.Any subject at screening or baseline with an AST (SGOT) or ALT (SGPT) greater than 3 times the upper limit of normal (ULN), or total bilirubin greater than 2 times the ULN.
    13.Subjects with evidence or history of clinically significant allergic reactions to drugs (eg, severe cutaneous and/or systemic allergic reactions).
    14.Subjects with a clinically significant ECG at the screening visit (as determined by the Principal Investigator or medically appropriate designee).
    15.Subjects taking a concomitant medication that is prohibited by this protocol.
    16. Subjects who intend to donate blood or blood components while receiving study drug or within one month of the completion of the treatment phase of the study.
    17. Subjects who do not agree to abstain from using non-cigarette tobacco products (including eg, pipe tobacco, cigars, snuff, chewing tobacco etc) or marijuana during study participation.
    18. Subjects who do not agree to abstain from using nicotine replacement therapy, bupropion, varenicline and other aids to smoking cessation during the treatment period of the study.
    19. Participation in other studies within 30 days before the current study begins and/or during study participation. With respect to smoking cessation studies, subjects should not have participated in such studies within 3 months before the current study begins, and are not permitted if they have previously participated in any varenicline study.
    20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Continuous Abstinence Rate for Weeks 9-12 (CAR 9-12), confirmed by exhaled carbon monoxide (CO) of less than or equal to 10ppm.
    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 No
    E.6.4Safety Yes
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 490
    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)
    This is a research study, the study drug, varenicline tartrate, and the study defined medical care will only be given to the subjects during the study, unless subjects experience adverse events which require appropriate follow-up.
    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 Decision2010-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-02
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