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    Summary
    EudraCT Number:2009-014916-37
    Sponsor's Protocol Code Number:A3051122
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-05
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-014916-37
    A.3Full title of the trial
    A PHASE 4 12-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF VARENICLINE TARTRATE (CP-526,555) 1MG BID FOR SMOKING CESSATION IN SUBJECTS WITH DEPRESSION
    A.4.1Sponsor's protocol code numberA3051122
    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
    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.3.8INN - Proposed INNVarenicline
    D.3.9.1CAS number 375815-87-5
    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 placeboTablet
    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 12.1
    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
    Compare 12 weeks of varenicline treatment to placebo for end of treatment smoking
    cessation efficacy in smokers with depression.
    E.2.2Secondary objectives of the trial
    •Compare 12 weeks of varenicline to placebo for long-term smoking abstinence
    through Week 52 in smokers with depression;
    •Summarize safety and tolerability data, including effects on psychiatric rating scales,
    for 12 weeks of treatment with either varenicline or placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject’s eligibility should be reviewed and documented by an appropriately qualified
    member of the investigator’s study team before subjects are included in the study. In
    addition, subjects shall only be included if they agree that their treating physicians, who are not involved in the study, will be informed of their study participation. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Male or female cigarette smokers, 18-75 years, motivated to stop smoking and
    considered suitable for a smoking cessation attempt.
    2. Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) >10 ppm at screening.
    3. Current or past diagnosis of MDD without psychotic features, either single or
    recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID
    and at least one of the following:
    • On stable antidepressant treatment for MDD (stable dose for at least 2 months);
    • Major depressive episode, using DSM IV TR, in the past 2 years successfully treated.
    4. 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
    5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
    6. 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 be excluded from the study:
    1. Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or
    other psychotic disorder, bipolar I disorder, bipolar II disorder or any other Axis I
    disorders. Exceptions for the following comorbid Axis I conditions are allowable: GAD, Dysthymia, Specific Phobia and Social Phobia.
    2. Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject’s ability to comply with the study requirements.
    3. Current use of either bupropion or nortryptiline.
    4. Current use of medications prescribed for mania or psychosis.
    5. Subjects who are believed to have a suicidal or homicidal risk (eg, after an
    assessment by a qualified mental health professional if the SBQ-R and C-SSRS
    screening assessment warranted suicidal risk assessment interview).
    6. Subjects who, in the investigator's judgment, would require treatment with any
    additional or different treatment modality, or with antipsychotics, or would require a
    change in intensity of psychotherapy, or an additional treatment with any other
    psychotherapeutic drugs during the course of the trial.
    7. Evidence of substance abuse/misuse severe enough to compromise the subject’s
    ability to comply with the study requirements (eg, consecutive positive urine drug
    screens).
    8. Subjects taking an investigational drug within 30 days before the Baseline visit.
    9. Subjects who have clinically significant medical disorders or laboratory test abnormalities.
    10. Subjects previously enrolled in a study that included varenicline (CP-526,555) or
    subjects who have previously taken Chantix/Champix.
    11. Subjects who intend to donate blood or blood components while receiving study drug or within 1 month of the completion of the treatment phase of the study.
    12. Subjects with severe chronic obstructive pulmonary disease (COPD).
    13. Subjects with a recent (<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.
    14. Subjects with evidence or history of clinically significant allergic reactions to drugs
    (eg, severe cutaneous and/or systemic allergic reactions).
    15. Any subject at screening with an SGOT (AST) or SGPT (ALT) greater than 3 times
    the upper limit of normal and/or total bilirubin greater than 2 times the upper limit of
    normal (ULN).
    16. Subjects with clinically significant cardiovascular disease in the past 6 months, such as myocardial infarction, coronary artery graft (CABG), percutaneous transluminal angioplasty (PTCA), severe or unstable angina, a serious arrhythmia, clinical significant ECG conduction abnormalities, or heart failure.
    17. Subjects with clinically significant cerebrovascular disease in the past 6 months, such as cerebrovascular incident (CVA), stroke, or documented transient ischemic attack (TIA).
    18. Subjects taking a concomitant medication that is prohibited by this protocol
    19. 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.
    20. Subjects with a body mass index (BMI) less than 15 or greater than 38, wearing
    indoor clothing without shoes and determined using a Body Mass Index (BMI) Table.
    (Appendix 1) No subject will be enrolled with a weight less than 100 pounds (45.5 kg).
    21. 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)
    The primary endpoint is the 4-week Continuous Quit Rate (CQR) for Weeks 9 through 12. The key secondary endpoint is the Continuous Abstinence rate from Week 9 through Week 52.
    Additional secondary endpoints include:
    • Continuous Abstinence rate from Week 9 through Week 24;
    • 7-day point prevalence of abstinence at Weeks 12, 24, and 52;
    • 4-week point prevalence of abstinence at Week 52.
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 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 Information not present in EudraCT
    F.3.2Patients Information not present in EudraCT
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 500
    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 not different from the expected normal treatment.
    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 Decision2010-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-13
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