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    Summary
    EudraCT Number:2005-004713-15
    Sponsor's Protocol Code Number:1235-SR-1005
    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:2005-11-22
    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 number2005-004713-15
    A.3Full title of the trial
    A Pilot Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centred Safety, Tolerability and Preliminary Efficacy
    Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion from AF
    A.4.1Sponsor's protocol code number1235-SR-1005
    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 Pharma Corp.
    B.1.3.4CountryCanada
    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 Information not present in EudraCT
    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 RSD1235-SR 300 mg overencapsulated tablets
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number 748810-28-8
    D.3.9.2Current sponsor codeRSD1235
    D.3.9.3Other descriptive nameUSAN: Pending name is Vernakant
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 300
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboCapsule, hard
    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 is the most common arrhythmia encountered in clinical practice. Atrial fibrillation is usually associated with age and general physical condition, rather than with a specific cardiac event. While not directly life-threatening, atrial arrhythmias can cause discomfort and can lead to stroke or congestive heart failure, and overall, increase morbidity.
    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
    The objectives of this study are to determine the safety and tolerability of two dose levels of RSD1235-SR and obtain preliminary information on the efficacy of RSD1235-SR in preventing the recurrence of atrial fibrillation or atrial flutter in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To participate in the study subjects must:

    - Comprehend and sign a written informed consent form, (including at US sites, HIPAA Authorisation; and at European sites, per EU Privacy Directive as implemented by member states in national law, as applicable);

    - Be over 18 to 85 years of age;

    - 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 3 months after the last dose of medication. Methods of birth control considered to be effective may include hormonal contraception (the pill), an intrauterine device (IUD), condoms in combination with a spermicidal cream, total abstinence or sterilisation. Men should be advised not to conceive a child and are advised to use an effective form of birth control from submission until 3 months after the last dose of study medication;

    - Have symptomatic AF that has been sustained for greater than 72 hours and less than 6 months duration;

    - Have adequate anticoagulant therapy in accordance with standard of practice as recommended by ACC/AHA/ESC guidelines (Fuster V. et al.,2001);

    - Be haemodynamically stable (100mmHg < systolic blood pressure < 190mmHg) at screening and on Day 1 before dosing (while taking rate control drugs, if required). After resting supine for 3 minutes, blood pressures should be measured 3 times in 5 minutes with at least 1 minute between assessments;

    - Have a body weight between 45 and 113 kg (99 and 250 lbs)
    E.4Principal exclusion criteria
    To participate in this study a subject may not:

    - Have known prolonged QT syndrome or uncorrected QT interval of >0.460 sec as measured at Screening on a 12-lead ECG; familial long QT syndrome; previous Torsades de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT).

    - Have a QRS >0.14 sec;

    - Documented previous episodes of second or third-degree atrioventricular block;

    - Have known bradycardia, sick-sinus syndrome or pacemaker;

    - Have significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis;

    - Have Class III or Class IV congestive heart failure at screening or admission, or have been hospitalised for heart failure in the previous 6 months;

    - Have unstable angina;

    - Have a myocardial infection (MI) or acute coronary syndrome within 30 days prior to entry into the study;

    - Have serious pulmonary, hepatic, metabolic, renal (serum creatinine > 2.0 mg/dl), gastrointestinal, central nervous system (CNS) or psychiatric disease, end-stage disease states, or any other disease that could interfere with the conduct or validity of the study or compromise subject safety;

    - Have known secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia (oxygen saturation < 90% on room air), acute pericarditis, cardiac surgery, or myocarditis;

    - Have previous thromboembolic disease (i.e. stroke);

    - Potassium (K+) <3.5 mmol/L (<3.5 mEq/L) or >5.5 mmol/L (>5.5 mEq/L) or Magnesium (Mg²+) below the lower limit of normal (<1.3 mEq/L). (Both K+ and Mg²+ should be corrected prior to dosing);

    - Have clinical evidence of digoxin toxicity;

    - Have received an oral Class I or Class III antiarrhythmic agent (including solalol) within 3 days of randomization or oral amiodarone within 4 weeks, or have received intravenous Class I or Class III antiarrhythmic agent or i.v. amiodarone within 24 hours prior to start of dosing;

    - Have any other surgical or medical condition that, in judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reasons;

    - Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to Screening;

    - Be unable to communicate well with the Investigator and to comply with the requirements of the entire study.
    E.5 End points
    E.5.1Primary end point(s)
    SAFETY ASSESSMENTS
    Safety assessments will consist of monitoring and recording of all adverse events (AE) and serious adverse events (SAE), the regular measurement of vital signs and 12-lead ECGs. Safety laboratory assays and physical exams will also be performed.
    EFFICACY ASSESSMENTS
    All efficacy parameters based on ECG data will be evaluated based on ECGs from TTMs, and 12-lead ECGs.
    AF symptoms (with patient diary and SCL) and Quality of Life will also be assessed.
    PHARMACOKINETIC ASSESSMENTS
    Population PK approach will be used to evaluate the RSD1235-SR PK profile in this study.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    This study is planned as a pilot study and all efficacy endpoints will be summarised using appropriate descriptive statistics. For continuous data, summaries will include the number of observations, mean, standard deviation, median, and minimum and maximum values. For categorical data, frequency counts and percentages will be used. For time-to-event data, Kaplan-Meier curves will be used to summarise the survival distributions.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 180
    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 Decision2005-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-08-17
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