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    Summary
    EudraCT Number:2007-003455-36
    Sponsor's Protocol Code Number:D3190C00005
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-10-30
    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 ConcernedFinland - Fimea
    A.2EudraCT number2007-003455-36
    A.3Full title of the trial
    A Multi-centre, Double-blind, Randomised, Placebo-controlled, Single-dose, Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness and Haemodynamics of an Intravenous Infusion of AZD1305 in Patients Undergoing an Invasive Electrophysiological Procedure
    A.4.1Sponsor's protocol code numberD3190C00005
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    AZD1305 is a novel antiarrhythmic agent being developed for treatment of atrial fibrillation (AF). Potential indications include conversion of AF to sinus rhythm (SR) and maintenance of SR after conversion of AF. The main purpose of this study is to provide proof that AZD1305 prolongs atrial refractoriness in patients with atrial flutter, who are scheduled for a clinically indicated catheter ablation intended to bring cure to their atrial flutter
    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
    Evaluate the effects of AZD1305, compared to placebo, on the left atrial effective refractory period (LAERP), in patients undergoing an invasive electrophysiological procedure (EP).
    E.2.2Secondary objectives of the trial
    1) Evaluate the effects of AZD1305, compared to placebo, on the right atrial effective refractory period (RAERP) in patients undergoing an invasive EP

    2) Evaluate the effects of AZD1305, compared to placebo, on the ventricular effective refractory period (VERP) and other electrophysiological and electrocardiographic variables in patients undergoing an invasive EP

    3) Investigate the effects of AZD1305, compared to placebo, on haemodynamic variables in patients undergoing an invasive EP

    4) Study the pharmacokinetic-pharmacodynamic relationship between plasma concentration of AZD1305 and QT /QTcF and if data is sufficient LAERP, RAERP and VERP

    5) Investigate the safety and tolerability of AZD1305 compared to placebo in this patient population

    6) Describe the pharmacokinetics of AZD1305 in this patient population

    7) Collect and store DNA samples for potential future exploratory research into genes, which may influence drug response of AZD1305.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written Informed Consent

    2. Patients with atrial flutter (with a ventricular rate of <100 beats/minute at enrolment), scheduled for curative catheter ablation with cryoablation or radiofrequency ablation

    3. Sinus rhythm at randomisation

    4. Male or postmenopausal* female, aged 20 to 80 years inclusive.

    For the optional genetic component of the study:
    5. Provision of specific written Informed Consent for genetic research.

    *Postmenopausal patients are defined as women fulfilling at least one of the following criteria:
    a) Natural menopause with last menstruation >1 year ago
    b) Induced menopause with last menstruation >1 year ago, due to:
    - Bilateral oophorectomy and/or hysterectomy
    - Radiation induced oophorectomy
    - Chemotherapy-induced menopause
    c) Serum FSH, LH and plasma oestradiol levels in the postmenopausal range
    E.4Principal exclusion criteria
    1. QTc (Fridericia, QTcF) >450 ms measured in sinus rhythm at randomisation

    2. Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L (confirmed within 24 h prior administration of the investigational product)

    3. QRS duration >120 ms at randomisation

    4. AV-block I (prolonged PQ (PR) interval defined as >220 ms), AV-block II, AV-block III at randomisation

    5. Left ventricular ejection fraction (LVEF) <40% on echocardiography, or other clinically significant abnormality on the echocardiogram as judged by the investigator (not older than 6 months)

    6. Systolic blood pressure <100 mmHg or >180 mmHg, or diastolic BP >105 mmHg at randomisation

    7. Congestive heart failure New York Heart Association (NYHA) class III or IV

    8. Glomerular filtration rate (GFR) calculated according to the Cockcroft-Gault formula <30 mL/min)

    9. Use of any antiarrhythmic drug class I and/or III and/or digitalis glucosides within five half-lives before administration of investigational product (for amiodarone within the preceding 3 months)

    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. Any clinically significant valvular heart disease

    12. Hypertrophic cardiomyopathy or significant left ventricular hypertrophy (free wall or septal thickness >13 mm)

    13. Known preexcitation with Wolff-Parkinson-White (WPW) syndrome or without arrhythmias

    14. 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

    15. Use of any QT prolonging drugs within five half-lives before administration of investigational product

    16. Need for general anaesthesia or DC cardioversion during the ablation procedure

    17. Clinically significant deviation in physical findings or laboratory values as judged by the Investigator

    18. Significant clinical illness or surgical procedure within 4 weeks preceding the pre-entry visit

    19. History of significant mental, renal or hepatic disorder, or other significant disease as judged by the Investigator

    20. History of severe allergic disease

    21. C-Reactive Protein (CRP) level >15 mg/L

    22. Uncontrolled hyperthyroidism/hypothyroidism as judged by the Investigator

    23. Blood haemoglobin <100 g/L at randomisation

    24. Clinical judgement by the Investigator that the patient should not participate in the study

    25. Inability to complete the study according to the Clinical Study Protocol

    26. History of drug addiction and/or alcohol abuse

    27. Blood or plasma donation within the preceding 12 weeks before administration of investigational product

    28. Intake of an investigational product within the preceding 3 months before the administration of the investigational products in this study

    29. A suspect or manifest infection according to WHO risk categories 2, 3 and 4

    30. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the investigational site).
    E.5 End points
    E.5.1Primary end point(s)
    Left atrial effective refractory period (LAERP)
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 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
    End of study is defined as database lock, which is the time point, after which no further data will be entered in the clinical study database.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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 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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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 Decision2007-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-06-29
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