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    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-001254-41
    Sponsor's Protocol Code Number:D3190C00013
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-15
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-001254-41
    A.3Full title of the trial
    A single-centre, single-blind, randomised, placebo-controlled phase IIa study to investigate the effect of AZD1305 given as an iv infusion on left ventricular performance in patients with left ventricular dysfunction
    A.4.1Sponsor's protocol code numberD3190C00013
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAZD1305 (AR-H055767)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    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
    Left ventricular function in patient with left ventricular dysfunction.
    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
    To explore if AZD1305 compromises left ventricular function in patients with left ventricular dysfunction.
    E.2.2Secondary objectives of the trial
    To evaluate the tolerability and safety of AZD1305 given as an intravenous (iv) infusion to patients with left ventricular dysfunction.

    To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction.

    To exploratively evaluate the relationship between dose, plasma concentration and QTcF interval, QRS duration and, if possible, left ventricular function.

    To collect and store DNA samples (from all randomised patients who give additional informed consent) 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 informed consent
    2. Male patients and postmenopausal women aged 20-80 years
    3. LVEF 30- 45% on echocardiography.Patients with an ejection fraction >45% can be included if he/she has a well documented diagnosis of cardiac failure/cardiomyopathy with a previous EF below 45% and is judged to have normal ejection fraction due to optimised medical treatment.
    4. In SR without diagnosis of AF during the dosing days.
    5. No significant changes in the medication for heart failure, during the preceding 1 month before enrolment (e.g. ACE inhibitors, AT1 blockers, beta-receptor blockers and/or aldosterone antagonists, diuretics) as judged by the investigator
    6. deleted
    7. Provision of written informed consent for genetic research (optional).
    1. Women will be considered postmenopausal if they fulfil criterion a) and/or b), and criterion c):
    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/or plasma oestradiol levels in the postmenopausal range as defined by the laboratory.
    E.4Principal exclusion criteria
    1. Clinically significant deviation in physical findings or laboratory values as judged by the investigator
    2. Severe or clinically unstable heart failure (NYHA III-IV)
    3. Haemodynamically unstable condition as judged by the investigator, systolic blood pressure (BP) <100 mmHg or >180 mmHg, or diastolic BP >105 mmHg at enrolment
    4. AV-block I (prolonged PQ (PR) interval defined as >220 ms), AV-block II, AV-block III, bundle branch block (BBB)
    5. QRS duration >120 ms at randomization
    6. QTcF interval >450 ms measured at randomization
    7. Any of the following events, or any other significant cardiovascular event as judged by the investigator, during the last 3 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) or coronary artery bypass grafting (CABG))
    8. Significant clinical illness or surgical procedure within 4 weeks preceding the pre-entry visit
    9. 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
    10. History of past or ongoing severe allergic disease, significant mental, renal or hepatic disorder, or other significant disease as judged by the investigator
    11. Known preexcitation
    12. History and/or signs of clinically significant sinus node dysfunction, or sinus rhythm with a heart rate (HR) below 45 or above 100 beats per minute
    13. Pacemaker or Implantable Cardioverter Defibrillator (ICD) therapy
    14. Significant aortic stenosis or hypertrophic obstructive cardiomyopathy
    15. C-Reactive Protein (CRP) >15 mg/L
    16. Potassium in serum or plasma below 3.8 or above 5.3 mmol/L
    17. Blood Haemoglobin (Hb) <100 g/L at randomisation
    18. Glomerular filtration rate (GFR) calculated according to the Cockcroft-Gault formula1 <30 mL/min
    1.Estimated glomerular filtration rate (GFR) for men and women as follows:
    1.Estimated glomerular filtration rate (GFR) for men and women as follows:
    Creatinine Clearance men=1.23 x (140 - age (years) x weight (kg)/serum creatinine (µmol/l)
    Creatinine Clearance women=1.04 x (140 - age (years) x weight (kg)/(serum creatinine (µmol/l)
    19. Intake of “over-the-counter”-drugs, including herbals, such as St John’s worth (within 3 weeks), vitamins, minerals and also grapefruit (including grapefruit juice) within one week before the first administration of AZD1305
    20. Use of any antiarrhythmic drug (e.g. class I and/or III, sotalol, digitalis glycoside, verapamil and amiodarone)
    21. Use of QT prolonging drug and/or drug that inhibits CYP3A4, as well as St John’s Worth within five half-lives before administration of AZD1305
    22. History of drug addiction and/or alcohol abuse and/or positive drug screen
    23. Clinical judgement by the investigator that the patient should not participate in the study
    24. A suspect or manifest infection according to IATA risk categories A and B
    25. Regular use of nicotine (smoking, snuff, nicotine chewing gum or nicotine plaster) daily (average of >7 cigarettes or snuff portions per week)
    26. Blood or plasma donation within the preceding 12 weeks before the administration of AZD1305 or other investigational product
    27. Intake of an investigational drug within the preceding 3 months before the first administration of AZD1305
    28. Intake of AZD7009 (predecessor of AZD1305) and/or AZD1305 at any time before administration of investigational product
    29. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    30. Previous randomization of treatment in the present study.
    E.5 End points
    E.5.1Primary end point(s)
    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 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 Yes
    E.8.1.4Double blind No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 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
    The end of the study is defined as the "last visit of the last patient 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 months9
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    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 Decision2008-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-08-19
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