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    EudraCT Number:2009-017838-44
    Sponsor's Protocol Code Number:CJO-201
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-03-03
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2009-017838-44
    A.3Full title of the trial
    A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary Efficacy Study of K201 Oral for the Prevention of Atrial Fibrillation (AF) Recurrence in Subjects Post-Conversion from AF
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCJO-201
    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 SponsorSequel Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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.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.3.1Product nameK201
    D.3.2Product code K201
    D.3.4Pharmaceutical form 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.3.9.1CAS number 1038410-88-6
    D.3.9.2Current sponsor codeK201
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    Atrial Fibrillation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety, efficacy, and tolerability of 3 doses of K201 administered for 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration >3 days and <6 months).

    E.2.2Secondary objectives of the trial
    See above
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Comprehend and sign a written informed consent form, (per local and national regulations, as applicable)
    2. Age of 18 years or more.
    3. Women must not be pregnant, be non-nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until the two week follow-up visit after the last dose of medication. Methods of birth control considered to be effective are hormonal anticonception; birth control pill, implant, transdermal depot adhesive, vaginal ring or depot injection), an intrauterine device (IUD), or sterilization. Men should be advised not to conceive a child and are advised to use an effective form of birth control from admission until the two week follow-up visit after the last dose of study medication
    4. Have symptomatic AF that has been sustained for greater than 3 days (72 hours) and less than 180 days (6 months) duration and is clinically indicated for cardioversion; subjects may have a mix of AF and atrial flutter if AF is predominant and was the presenting arrhythmia.
    5. Have adequate anticoagulant therapy for cardioversion in accordance standard of practice as recommended by ACC/AHA/ESC guidelines 8 or with local clinical practice (e.g. TEE algorithm);
    6. Be hemodynamically stable (90 mmHg < systolic blood pressure < 190 mmHg) at screening and on Day 1 before dosing (while taking rate control drugs, if required).
    7. Subject has a Body Mass Index (BMI) < 35
    E.4Principal exclusion criteria
    1. At screening, have known prolonged QT syndrome, familial Long QT syndrome, QTcF interval of >500 msec as measured on a 12-lead ECG while in AF; previous history of Torsade de Pointes, ventricular fibrillation, or sustained ventricular tachycardia (VT); After DC cardioversion and while in sinus rhythm, QTcF >440/450 ms for males/females, respectively.
    2. Have a QRS >0.130 sec.
    3. Previous episodes of second or third-degree atrioventricular block.
    4. Last DC cardioversion attempt occurred within 3 months and was unsuccessful (including IRAF); or any prior ablation for AF.
    5. Have persistent bradycardia with ventricular rate below 50 beats/min that in the opinion of the investigator is clinically significant, sick-sinus syndrome or pacemaker (including CRT, AICD). Have persistent tachycardia greater than 110 beats/min.
    6. Have clinically significant moderate or severe valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis.
    7. Have NYHA Class III or Class IV heart failure (HF) at screening or admission, have been hospitalized with HF or new diagnosis of HF in the previous 6 months; any change in HF medications within 2 months; NT-proBNP > 47 pmol/l; EF<45% obtained within two weeks prior to cardioversion.
    8. Have a myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study; Have serious pulmonary, hepatic (i.e. ALT >3X ULN), metabolic, renal (i.e. eGFR < 30mL/min), gastrointestinal, central nervous system (i.e. stroke or TIA within past 6 months) or psychiatric disease (e.g. drug addiction or alcohol dependence), end-stage disease states, or any other disease that in the opinion of the investigator could interfere with the conduct or validity of the study or compromise subject safety.
    9. Have known concurrent temporary secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia (oxygen saturation < 90% on room air), acute pericarditis, or myocarditis.
    10. Hypokalemia (K+ should be corrected prior to dosing).
    11. Have clinical evidence of digoxin toxicity.
    12. Have received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks.
    13. Have received treatment with other drugs known to prolong the QT interval within 5 half-lives, including, certain antidepressants (e.g. tricyclic antidepressants), certain antihistaminics (e.g. terfenadine, astemizole), certain antiinfectives (e.g. erythromycin), certain antipsychotics (e.g. haloperidol, pimozide, thioridazine, ziprasidone); certain cardiovascular non-antiarrhythmics (e.g. bepridil), certain gastro-intestinal agents (e.g. cisapride).
    14. Have any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reasons.
    15. Be concurrently participating in another investigational drug study or have received an investigational drug within 30 days or 5 half-lives prior to screening.
    16. Be unable to communicate well with the Investigator and to comply with the requirements of the entire study.
    17. Have received potent CYP2D6 or CYP3A inhibitors within 5 half-lives. Potent CYP2D6 include bupropion, fluoxetine, paroxetine, cinacalcet and quinidine. Potent CYP3A inhibitors include indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, ketoconazole, vorikonazole, posakonazole, and nefazodone
    E.5 End points
    E.5.1Primary end point(s)
    The objective of this study is to estimate the effects of K201 over 28 days on the following endpoints of interest:

    1. Time to first documented recurrence of symptomatic AF

    2. Time to first documented recurrence of symptomatic or asymptomatic AF
    3. Proportion of subjects in sinus rhythm on Day 28
    4. During 10 days of continuous Holter monitoring, Number of AF beats
    5. During 10 days of continuous Holter monitoring, Time in AF (atrial fibrillation defined as > 30 consecutive beats of AFib/flutter origin)
    6. Change in AF symptoms as assessed by the AF symptom checklist.
    7. Change in CCS-Severity of AF scale
    8. Days dead or in AF during 28 days
    9. Days dead or hospitalized during the 28 days
    10. Proportion of subjects with CV mortality or AF re-admission to day 28

    Safety and tolerability in randomised subjects will be continuously evaluated based on Adverse Events/Serious Adverse Events (AE/SAE) reporting and monitoring of laboratory evaluations, ECG and vital signs.

    Safety parameters will include:

    • Physical examinations, medical history, vital signs, ECG, standard laboratory test panels, and monitoring of adverse events.
    • ECGs assessments by 12-lead ECGs recorded at scheduled clinic visits. Holter/TTEM data will be read by an independent core lab.
    • Safety variables of particular interest include the hemodynamic parameters of blood pressure and heart rate as well as ECG parameters and analyses of QT, QTcB, QTcF, the incidence of Torsade des pointes, and other ventricular arrhythmias, including bradyarrhythmias.

    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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. 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 concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Please refer to protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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 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.1.3Elderly (>=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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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 Decision2010-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-03-16
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