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    Summary
    EudraCT Number:2004-000984-81
    Sponsor's Protocol Code Number:04-7-010
    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:2004-07-15
    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 number2004-000984-81
    A.3Full title of the trial
    A PHASE III PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, TOLERANCE AND EFFICACY STUDY OF RSD1235 IN SUBJECTS WITH ATRIAL FIBRILLATION OR ATRIAL FLUTTER
    A.3.2Name or abbreviated title of the trial where available
    ACT III
    A.4.1Sponsor's protocol code number04-7-010
    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 SponsorAstellas Pharma US, 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.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.3.1Product nameRSD1235
    D.3.4Pharmaceutical form Intravenous 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 codeRSD1235
    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 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 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 placeboIntravenous 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
    Arrhythmias are abnormal rhythms of the heart. The term arrhythmia refers to a deviation from the normal sequence of initiation and conduction of electrical impulses, which cause the heart to beat. Arrhythmias may occur in the atria or the ventricles. Atrial arrhythmias are widespread and relatively benign.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 61
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of AF or AFL to SR. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to SR for a minimum of 1-minute within Hour 1.5 from the start of the first infusion (Time 0).
    E.2.2Secondary objectives of the trial
    To assess the safety of RSD1235 in the AF/AFL subject population;
    To assess the proportion of subjects with AF or AFL of 3 hours to 45 days in duration, who have treatment-induced conversion of AF/AFL to SR within 1.5 hours of first exposure to study drug and for a minimum duration of one minute.
    To assess the proportion of subjects with AF or AFL of greater than 7 days to 45 days in duration, who have treatment-induced conversion of AF/AFL to SR within 1.5 hours of first exposure to study drug and for a minimum duration of one minute.
    To assess the time taken from exposure to first treatment to first conversion to SR for a minimum duration of one minute.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    a)Comprehend and sign a written informed consent and at US sites, HIPAA Authorization; and at Canadian sites, PIPEDA Authorization;
    b)Be 18 years of age or older;
    c)Women must be non-pregnant, non-nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 30-day follow-up. Methods of birth control considered to be effective would include hormonal contraception (the pill), an intrauterine device (IUD), condoms in combination with a spermicidal cream, total abstinence or sterilization;
    d)Have either AF or AFL (with or without symptoms) that has been sustained for greater than 3 hours and up to 45 days. The presence of atrial arrhythmia will be documented by a 12-lead ECG recording at Screening. For this protocol AFL will be limited to “typical” AFL based on the following criteria: AFL with a regular atrial rate of 220-320 bpm with a typical sawtooth pattern in leads II, III and aVF and predominantly negative flutter waves in V6 and positive or biphasic in V1. Atrial fibrillation is characterized by atrial activity which is either absent or chaotic both in amplitude and in rate. Non-typical forms of AFL will be categorized as AF;
    e)Have adequate anticoagulant therapy in the judgment of the Investigator. (If AF/AFL has lasted more than 48 hours then subjects should be managed in accordance with standard of practice as recommended by ACC/AHA/ESC practice guidelines) (1);
    f)Systolic blood pressure (BP) above 90 mmHg and less than 160 mmHg and diastolic BP less than 95 mmHg at screening and baseline. Blood pressures will be measured 3 times within 5 minutes, after resting supine for 5 minutes and averaged to determine a baseline BP.
    E.4Principal exclusion criteria
    a)Have known or suspected prolonged QT or uncorrected QT interval of >0.440sec as measured at Screening on a 12 lead ECG, familial long QT syndrome, or previous Torsades de Pointes;
    b)Have symptomatic bradycardia or ventricular rate less than 50 bpm as documented by 12-lead ECG at Screening, unless controlled by a pacemaker;
    c)Have a QRS interval > 0.14 sec unless subject has pacemaker at screening;
    d)Have Class IV congestive heart failure (HF) or HF requiring intravenous inotrope therapy, or be in cardiogenic or septic shock or other forms of shock requiring vasopressors or mechanical ventilation;
    e)Have a Myocardial Infarction (MI), acute coronary syndrome or cardiac surgery within 30 days prior to randomization;
    f)Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to enrollment, or have previously received RSD1235;
    g)Have any known secondary causes of AF/AFL such as alcohol intoxication, pulmonary embolism, hyperthyroidism, acute pericarditis or hypoxemia (oxygen saturation less than 90% on room air);
    h)Have serious pulmonary, hepatic, metabolic, renal, gastrointestinal, central nervous system or psychiatric disease, infection, febrile illness (oral temperature > 38.5°C), end stage disease states, or any other disease that could interfere with the conduct or validity of the study or compromise subject safety;
    i)Have failed electrical cardioversion for AF or AFL at any time;
    j)Have uncorrected electrolyte imbalance (serum potassium of less than 3.5 mmol/L must be corrected and documented 6 hours or less prior to randomization);
    k)Have clinical evidence of digoxin toxicity in the opinion of the Investigator;
    l)Have received intravenous Class I or Class III antiarrhythmic drugs or IV amiodarone within 24 hours prior to randomization;
    m)Be unable to communicate well with the Investigator and to comply with the requirements of the entire study;
    n)Have any other surgical or medical condition that, in the judgment of the Investigator might warrant exclusion or be contraindicated for safety reasons.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the proportion of subjects with AF of greater than 3 hours and less than or equal to 7 days in duration, who have treatment-induced conversion of AF to sinus rhythm (SR) within 1.5 hours of first exposure to study medication and for a minimum duration of one minute.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.5The 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
    End of trial will be 30 days +/- 5 days after last patient randomized.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    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 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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 280
    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)
    In case the patient did not convert to sinus rhythm after exposure to study drug standard treatment will be given to the patient, preferable at least 2 hours after exposure to study drug
    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 Decision2004-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-07-30
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