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    Summary
    EudraCT Number:2010-022947-39
    Sponsor's Protocol Code Number:CV203-010
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-022947-39
    A.3Full title of the trial
    Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Safety, Tolerability and Effect on Atrial Fibrillation Burden of BMS-914392 in Patients with Paroxysmal Atrial Fibrillation and Permanent Pacemaker

    Revised Protocol 03 to incorporate Protocol Amendment 02, 03 & 04 and Admin letter 01.
    + Pharmacogenetics Blood Sample Amendment 01 - Site Specific (1.0, 10-Nov-2010)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate the Safety, Tolerability and Effect on Atrial Fibrillation Burden
    A.4.1Sponsor's protocol code numberCV203-010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01356914
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start Up Unit
    B.5.3 Address:
    B.5.3.1Street Address8 avenue de Finlande
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.com
    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.3.1Product nameBMS-914392-01 / NTC-801F
    D.3.2Product code BMS-914392-01 / NTC-801F
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 codeBMS-914392-01
    D.3.9.3Other descriptive nameNTC-801F
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atrial Fibrillation
    E.1.1.1Medical condition in easily understood language
    Atrial Fibrillation
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10003661
    E.1.2Term Atrial fibrillation paroxysmal
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10034039
    E.1.2Term Paroxysmal atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    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 is to assess, by the use of long term beat to beat pacemaker monitoring, the effect of BMS-914392 on the reduction of placebo-corrected AF burden (% of time spent in AF) in pacemaker subjects with paroysmal AF.
    E.2.2Secondary objectives of the trial
    • To assess the effect of BMS-914392 on the total number of AF episodes, average duration of AF per episode, and average sinus rhythm duration derived from continuous pacemaker monitoring.
    • To assess the effect of BMS-914392 on subject-perceived AF-related symptoms through self-reporting using the Canadian Cardiovascular Society Atrial Fibrillation Severity Scale (CCS-AFSS).
    • To assess the safety and tolerability of BMS-914392.
    • To assess the effect of BMS-914392 on PR, QRS, RR, QT, and QTc intervals derived from 12-lead ECGs for periods of sinus rhythm.
    • To assess the pharmacokinetics of BMS-914392 on Day 1 and Day 8 of Period 1, 2, 3, and 4.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy
    • Paroxysmal atrial fibrillation (AF) within 6 month prior to screening.
    • Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics that was implanted for a primary or secondary indication at least 1 month with a stable peacemaker assessment prior to screening.
    a. 1-50% AF burden (% of time spend in AF) on pacemaker interrogation at screening.
    • Any oral anticoagulant approved for use in atrial fibrillation for prevention of stroke or other embolic disease.
    • Able to tolerate withdrawal of antiarrhythmic therapy.
    • Able to tolerate pacemaker antiarrhythmic algorithms turned off.
    • Clinically stable at the time of randomization as determined by the investigator.
    E.4Principal exclusion criteria
    • AF burden <1% and > 50% on pacemaker interrogation prior to first dosing.
    • Permanent AF.
    • Development of persistent AF prior to first dosing.
    • Any significant acute or chronic medical illness that is severe, progressive or uncontrolled at the time of screening.
    • Current or history of neurological diseases and mental disorders, including syncope, convulsive disorders such as epilepsy, central thrombosis and cerebral embolism, stroke, or accidents involving brain injuries.
    • History of TIA in the last 12 months.
    • History of Ventricular Arrythmia.
    • Cardioversion within 3 months of study drug administration.
    E.5 End points
    E.5.1Primary end point(s)
    • AF burden: percent of time in which a subject is in AF
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured from Day 8 to Day 22 of Periods 1, 2, 3, 4 and Day 1 to Day 8 of period 5.
    E.5.2Secondary end point(s)
    • Total number of AF episodes
    • Average duration of AF per episode
    • Average sinus rhythm duration
    • Self-reported AF symptoms
    • ECG intervals derived from 12-lead ECGs

    • Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, 12-lead ECGs, physical and neurological examinations and clinical laboratory tests. The incidence of observed adverse events will be tabulated and reviewed for potential significance and clinical importance.

    • Pharmacokinetic Measures:
    Observed Cmin at steady state (Day 7)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout of the Treatment Period
    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 No
    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 No
    E.8.1.6Cross over Yes
    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.8.2.4Number of treatment arms in the trial4
    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 No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    Study drug will not be available to study subjects after completion of this clinical study.
    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 Decision2011-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-13
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