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    Summary
    EudraCT Number:2010-018374-20
    Sponsor's Protocol Code Number:6517-CL-0020
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-22
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-018374-20
    A.3Full title of the trial
    A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients with Recent Onset Symptomatic Atrial Fibrillation
    A.4.1Sponsor's protocol code number6517-CL-0020
    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 SponsorCardiome UK Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsor
    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 organisationCardiome UK Ltd
    B.5.2Functional name of contact pointCéline Combet
    B.5.3 Address:
    B.5.3.1Street AddressLakeside House, 1 Furzeground Way, Stockley Park,
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BD
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailregulatory@cardiome.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 nameVernakalant
    D.3.4Pharmaceutical form Solution for injection
    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.3.8INN - Proposed INNVernakalant Hydrochloride
    D.3.9.1CAS number 748810-28-8
    D.3.9.2Current sponsor codeKSD1235
    D.3.9.3Other descriptive nameVernakalant
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 injection
    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
    Recent Onset Symptomatic Atrial Fibrillation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term 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 safety objective of this study is to evaluate the safety of vernakalant injection in subjects with recent onset (AF > 3 hours to less than or equal to 7 days), symptomatic atrial fibrillation, and no evidence or history of congestive heart failure (CHF).

    The primary efficacy objective is to demonstrate the efficacy of vernakalant injection in
    converting atrial fibrillation (AF) to sinus rhythm (SR) in subjects with recent onset (AF > 3h to less than or equal to 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure (CHF).
    E.2.2Secondary objectives of the trial
    The study will evaluate the influence of CYP2D6 genotype status on the pharmacokinetics and pharmacodynamics of vernakalant (and its metabolites).

    Additionally, the study allows for an exploratory analysis of safety and healthcare resource utilization between vernakalant and electrocardioversion (ECV).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The study will evaluate the influence of CYP2D6 genotype status on the pharmacokinetics and pharmacodynamics of vernakalant (and its metabolites).
    E.3Principal inclusion criteria
    Subject is eligible for the study if all of the following apply:
    1. Institutional Review board (IRB)-/Independent Ethics Committee (IEC)- approved written Informed Consent and privacy language as per national regulations (e.g. HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable);
    2. Subject must be between the ages of 18 and 85, inclusive;
    3. Females must be not pregnant or nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 30 days post study treatment;
    4. Subject must have recent onset (> 3 hours to less than or equal to 7 days) symptomatic AF determined by the Investigator to be best managed by acute conversion to SR. The presence of atrial fibrillation will be documented by a 12-lead ECG recording at Screening and Baseline;
    5. Subject must have, in the judgment of the Investigator, adequate anticoagulant therapy (AF has lasted more than 48 hours, subjects should be managed in accordance with standard of practice as recommended by ACC/AHA/ESC practice guidelines)
    6. Subject must have systolic blood pressure (SBP) above 90 mmHg and less than 160 mmHg and diastolic blood pressure (DBP) less than 95 mmHg at Screening (single measurement) and Baseline (mean of triplicate measurements);
    7. Subject must be, in the judgment of the Investigator, adequately hydrated and have a normal saline IV established and infusing;
    8. Subject must have a body weight between 45 and 136 kg, inclusive (99 and 300 lbs).
    E.4Principal exclusion criteria
    Subject will be excluded from participation if any of the following apply:
    1. Subject has a history of heart failure or documentation of left ventricular dysfunction evidenced by any of the following:
    a- History of heart failure defined as physician documentation or report of any of the following symptoms of heart failure before this care encounter, described as dyspnea, fluid retention, and/or low cardiac output secondary to cardiac dysfunction; or the description of rales, jugular venous distension, or pulmonary edema. A previous hospital admission with diagnosis of heart failure is considered evidence of heart failure history
    b- Objective evidence of heart failure during the present care encounter with documentation of rales, jugular venous distension, or pulmonary edema.
    c- Left ventricular dysfunction defined as an ejection fraction of less than 40%, if available. An echocardiogram is not required for enrollment in this study.
    2. Subject has known or suspected prolonged QT or uncorrected QT interval of > 0.440 sec. as measured at Screening on a 12-lead ECG, familial long QT syndrome, or previous Torsade de Pointes;
    3. Subject has symptomatic bradycardia or ventricular rate less than 50 bpm documented by 12-lead ECG at Screening, unless controlled by a pacemaker;
    4. Subject has bradycardia (heart rate less than 50 bpm) or hypotension (SBP less that 90 mmHg) after receiving a loading, bolus dose, or sustained infusion of any rate control medication during Screening;
    5. Subject has a QRS interval > 0.14 sec., unless subject has a pacemaker;
    6. Subject had a myocardial infarction (MI), acute coronary syndrome, cardiac surgery
    (including PTCA or stent placement), within 30 days prior to enrollment or subject has evidence of new ischemic changes on Screening 12-lead ECG;
    7. Subject has troponin I or T levels beyond the upper limit of normal for the local lab at
    Screening;
    8. Subject has significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis;
    9. Subject has failed electrical cardioversion for AF at anytime;
    10. Subject has failed pharmacologic conversion with an intravenous Class I or Class III antiarrhythmic drug for this episode of AF;
    11. Subject has any known reversible causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, acute pericarditis or hypoxemia (oxygen saturation less than
    90% of room air);
    12. Subject has uncorrected electrolyte imbalance (serum potassium less than 3.5 mmol/L must be corrected and documented 6 hours or less prior to enrollment, hypomagnesemia of any level is an exclusion);
    13. Subject has clinical evidence of digoxin toxicity in the opinion of the Investigator;
    14. Subject has a history of clinically significant illness (e.g. neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, endocrine, hematological, or psychiatric), medical condition or laboratory abnormality within 4 weeks prior to Screening, that in the Investigator’s opinion, would preclude the subject from participating in the trial;
    15. Subject is unable to communicate well with the Investigator and to comply with the requirements of the entire study;
    16. Subject has previously participated in a vernakalant study, is concurrently participating in another drug study, or has received an investigational drug within 30 days prior to Screening.
    E.5 End points
    E.5.1Primary end point(s)
    Using a two-sided chi-square test with a significance level of 0.05, this sample size will provide more than 98% power to detect a treatment difference of 35% in the primary efficacy endpoint of conversion of AF to sinus rhythm between the two treatment groups assuming the placebo conversion rate is 10%.

    The primary analysis will use subjects in the safety analysis set (SAF) from the vernakalant group only. A one-sided 95% confidence interval using the Exact method for a single proportion will be used to provide an interval estimate of the incidence for the primary composite safety endpoint. In addition, the placebo group will be summarized using the same methodology.

    A subject is considered success for this exploratory efficacy endpoint if the subject converted to SR as defined in the primary efficacy variable and maintained SR documented by Holter or by two consecutive 12-lead ECGs recorded > 1 minute apart at 24 +/minus 4 hours.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 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
    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 months8
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days28
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 450
    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 Decision2010-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-20
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