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    Summary
    EudraCT Number:2005-004411-29
    Sponsor's Protocol Code Number:A3051049
    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:2005-11-23
    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 number2005-004411-29
    A.3Full title of the trial
    A 12-week, double-blind, placebo-controlled, multicenter study with a 40 week follow-up evaluating the safety and efficacy of Varenicline tartrate 1 mg BID for smoking cessation in subjects with cardiovascular disease
    A.3.2Name or abbreviated title of the trial where available
    Not available
    A.4.1Sponsor's protocol code numberA3051049
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot available
    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
    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 Tartrate
    D.3.9.1CAS number 375815-87-5
    D.3.9.2Current sponsor codeCP-526, 555
    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.IMP: 2
    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 Tartrate
    D.3.9.1CAS number 375815-87-5
    D.3.9.2Current sponsor codeCP-526, 555
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 2
    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 9.1
    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
    Main objective: The primary efficacy objective of this protocol is a comparison of 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation in subjects with cardiovascular disease and to evaluate continuous abstinence from smoking 40 weeks after the treatment period.
    E.2.2Secondary objectives of the trial
    Secondary objectives: The safety objective is to gather safety data in subjects with cardiovascular disease for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by a 40 week nontreatment follow-up period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    1. Subjects must be able to be outpatients, to be assessed in a clinic setting, and be able and willing to comply with all study visits for 52 weeks during the treatment and
    non-treatment phases
    2. Participating subjects must be able to provide written informed consent
    3. Only one subject per household may participate
    4. Subjects must be current cigarette smokers, male or female, who are between the ages of 35 and 75 years, inclusive, and who are motivated to stop smoking
    5. Subjects must have smoked an average of at least 10 cigarettes per day during the past 12 months and during the month prior to the Screening visit
    6. Subjects must have stable, documented cardiovascular disease other than hypertension diagnosed >2 months prior to the Screening visit. Examples include:
    • Coronary Artery Disease demonstrated by:
    Angina pectoris and evidence of abnormal myocardial perfusion or myocardial
    ischemia by stress testing or myocardial perfusion imaging or angina pectoris with
    positive coronary angiography. Test results or physician report must be provided.
    Myocardial infarction documented by hospital summaries, procedure reports,
    laboratory reports, etc.
    Coronary revascularization documented by physician or procedure report
    • Peripheral Vascular Disease demonstrated by:
    Stable peripheral vascular disease (arterial) documented by history and physical exam
    (ankle-brachial index-ABI <0.9 but > 0.5), ultrasonography, arteriography. Subjects
    with asymptomatic carotid disease documented by imaging studies may be included
    Peripheral revascularization documented by procedure report
    • Cerebrovascular Disease. For example, TIA or stroke without significant
    neurological impairment documented by neurological evaluation, procedure
    report.
    7. Females who are not of childbearing potential (eg, 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 serum pregnancy test (β-hCG) at screening
    • Agree to use at least one of the birth control methods listed below:
    • An oral contraceptive agent, an intrauterine device (IUD), an implantable
    contraceptive (for example, Norplant), or an injectable contraceptive (for
    example, 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
    • A barrier method of contraception, for example, condom and/or diaphragm with
    spermicide while participating in the study through at least 30 days after the last
    dose of study medication
    • Abstinence
    E.4Principal exclusion criteria
    1. Subjects who have made a serious attempt to quit smoking in the past 3 months but have failed
    2. Subjects currently suffering with depression, or who have been diagnosed with
    depression or treated with an anti-depressant for depression within the past 12 months
    3. Subjects with a past or present history of psychosis, anxiety disorder, panic disorder, or bipolar disorder
    4. Subjects who, in the judgment of the investigator, have moderate or severe chronic obstructive pulmonary disease (COPD) (see Appendix 1 of the protocol for definitions of severity based on spirometry; however a study specific spirometry is not required. Subjects who have had a previous hospitalization for COPD should be excluded
    5. Subjects with NYHA Class III or IV congestive heart failure (see Appendix 2 of the protocol for NYHA Classification)
    6. Subjects with unstable cardiovascular disease or cardiovascular events in the past 2 months. Examples include, coronary artery bypass graft (CABG), percutaneous
    transluminal coronary angioplasty (PTCA), severe or unstable angina, serious (life
    threatening) arrhythmia, and clinically significant cardiac conduction abnormalities
    (>10 AV block)
    7. Subjects with uncontrolled hypertension or a systolic blood pressure greater than
    160 mmHg or a diastolic blood pressure greater than 95 mmHg at the Screening or
    Baseline visit
    8. Subjects with clinically significant neurological deficits related to cerebrovascular or
    other diseases, for example, stroke, etc.
    9. Subjects with peripheral vascular disease (PVD) which has resulted in amputation or where the ankle-brachial index is ≤0.5.
    10. Subjects with a history of clinically significant endocrine disorders or gastrointestinal diseases that are uncontrolled, including uncontrolled hyperthyroidism, and active peptic ulcer diseaseSubjects with clinically significant hepatic or renal impairment or other clinically
    significant abnormal laboratory test values:
    Subjects with an SGOT (AST) or SGPT (ALT) greater than 1.5 times the upper limit
    of normal (ULN) or total bilirubin greater than 1.1 times the ULN
    Subjects with severe abnormalities of renal function (estimated creatinine clearance
    by Cockcroft-Gault equation <30 mL/min) (Appendix 3)
    12. Subjects with a history of cancer (cured basal cell or squamous cell carcinoma of the skin allowed)
    13. Subjects with a history of drug (except nicotine) or alcohol abuse or dependence
    within the past 12 months
    14. Subjects with a positive urine drug screen for drugs of potential abuse and no medical indication for use of the drug.
    15. Subjects with a body mass index (BMI) less than 15 or greater than 38 when wearing indoor clothing without shoes (see Appendix 5 of the protocol). No subject will be enrolled with a weight less than 45.5 kg (100 pounds)
    16. Subjects previously enrolled in a study that included varenicline (CP-526,555)
    17. Subjects taking another investigational drug within 30 days or 5 half-lives (whichever is longer) before the Baseline visit or within 30 days of completion of another study
    18. Subjects taking a concomitant medication that is prohibited by this protocol (see
    Section 5.5 of the protocol)
    19. Subjects requiring other medications during the study that might interfere with the evaluation of the study drug (for example, nicotine replacement therapy, bupropion, clonidine, nortriptyline, or other medications used for smoking cessation including over the counter herbal remedies)

    Exclusion criteria 20 to 26 has been left out due to lack of space. Please refer to section 4.2 Exclusion criteria of the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the 4-week Continuous Quit Rate (CQR) for Weeks 9-12, i.e., the proportion of subjects who are able to maintain complete abstinence from cigarette smoking and other nicotine use, with end-expiratory exhaled CO measurements ≤10 ppm, for the planned last 4 weeks of treatment.
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 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
    Not Applicable
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 700
    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)
    Not Applicable
    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 Decision2005-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-18
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