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    Summary
    EudraCT Number:2007-007058-79
    Sponsor's Protocol Code Number:D3190C00019
    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:2008-01-25
    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 number2007-007058-79
    A.3Full title of the trial
    A Randomised, Placebo-controlled, Double-blind, Parallel-group, Multicentre, Phase IIa Study to Explore the Relationship between QTcF Interval at First Dose (Loading Dose) and at Steady State after Treatment with AZD1305 Extended-release Tablets or Placebo when given to Patients with Documented AF
    A.4.1Sponsor's protocol code numberD3190C00019
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 No
    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.3.2Product code AZD1305 (AR-H055767)
    D.3.4Pharmaceutical form Prolonged-release 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.3.9.2Current sponsor codeAZD1305
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    The main purpose of this study is to investigate the feasibility to use a loading dose as a tool for identifying patients who may have an exaggerated QT response to AZD1305 and would therefore not be candidate for long term treatment.
    MedDRA Classification
    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 explore the relationship between QTcF at first dose (loading dose) and QTcF at steady state after treatment with AZD1305, in order to identify outliers with regards to QTcF response when given to patients with documented AF but presently in stable SR for at least 2 h and a maximum of 28 days.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to:
    · investigate the safety and tolerability of AZD1305 compared to placebo
    · evaluate the Pharmacokinetics (PK) of AZD1305 with special regard to:
    - evaluation of the influence of concomitant medication and demographic variables on the PK variables of AZD1305
    - assessment of the relationship between exposure of AZD1305 and QTcF
    · evaluate the use of trans telephonic monitoring (TTM) measured as patient compliance, number of unscheduled recordings and correlation between symptoms and rhythm
    collect blood samples for future DNA analysis in the optional genetic research part of the study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent
    2. Male subjects and postmenopausal women aged 20-80 years
    3. Documented AF
    4. SR, for a minimum of 2 hours and a maximum of 90 days, at randomisation
    5. Effective oral anticoagulation according to international and/or national guidelines. In self-terminating AF with a duration of less than 48 hours, decision on anticoagulation should be made according to guidelines (Fuster et al 2006)
    For the optional genetic component of the study:
    6. Provision of written informed consent for genetic research
    E.4Principal exclusion criteria
    1. Clinically significant deviation in physical findings or laboratory values as judged by the Investigator.
    2. Significant clinical illness or surgical procedure within four weeks preceeding the pre-entry visit (Visit 1)
    3. History of severe allergic disease, significant mental, renal or hepatic disorder, or other significant disease as judged by the Investigator
    4. History of severe skin reactions due to use of electrodes
    5. C-Reactive Protein (CRP) >15 mg/L
    6. Estimated Creatinine clearance/glomerular filtration rate (GFR) according to the Cockcroft-Gault formula <30 mL/min
    7. Uncontrolled hyperthyroidism or hypothyroidism as judged by the Investigator
    8. Blood Haemoglobin (Hb) <100 g/L at randomisation
    9. Ongoing AF or atrial flutter at randomisation
    10. Any of the following events, or any other significant cardiovascular event as judged by the Investigator, during the last 6 months before randomisation: myocardial infarction, unstable angina pectoris or other signs of myocardial ischaemia, stroke or transient ischaemic attack (TIA), myocardial revascularisation (percutaneous coronary intervention (PCI)), coronary artery bypass graft (CABG), or other revascularisation procedure.
    11. Haemodynamically unstable condition as judged by the Investigator, systolic BP <100 mmHg or >180 mmHg, or diastolic BP >105 mmHg at randomisation
    12. Congestive heart failure New York Heart Association (NYHA) class III or IV
    13. Left ventricular ejection fraction (LVEF) <40% on echocardiography, or other clinically significant abnormality on the echocardiogram (not older than 6 months) as judged by the Investigator
    14. History and/or signs of clinically significant sinus and/or AV nodal dysfunction
    15. Sinus bradycardia (<50 beats per minute (bpm)) at randomisation
    16. Any clinically significant valvular heart disease
    17. Hypertrophic cardiomyopathy or significant left ventricular hypertrophy (free wall or septal thickness >13 mm)
    18. Pacemaker or Implantable Cardioverter Defibrillator (ICD) therapy
    19. Known preexcitation
    20. Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia (PVT), sustained ventricular tachycardia, long QT syndrome and/or Brugada syndrome
    21. QTc (Fridericia, QTcF ) interval >450 ms measured in SR at randomisation
    22. QRS duration >120 ms at randomisation
    23. AV-block I (prolonged PQ (PR) interval >220 ms), AV-block II, AV-block III, or complete bundle branch block (BBB) at randomisation
    24. Serum potassium below 3.8 or above 5.3 mmol/L, or plasma potassium below 3.6 or above 5.3 mmol/L at randomisation
    25. Use of any antiarrhythmic drug class I and/or III, digitalis glycoside, QT prolonging drug and/or drug that inhibits CYP3A4, as well as St John’s Worth within five half-lives before administration of AZD1305 or other IP (for amiodarone within the 3 months before enrolment).
    26. Intake of an investigational drug within the preceeding 3 months before administration of AZD1305 or other IP
    27. Intake of AZD7009 and/or AZD1305 at any time before administration of AZD1305 or other IP
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable for this study is QTcF as measured by the Investigator following the loading dose, at Study Day 4, at Study Day 6 and at Study Day 10
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned7
    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
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 80
    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 Decision2008-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-30
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