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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-000671-17
    Sponsor's Protocol Code Number:3163 K1-200-WW
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-07-13
    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 number2005-000671-17
    A.3Full title of the trial
    A Safety and Efficacy Dose-Ranging Study of GAP-486 in Subjects With Nonsustained Ventricular Tachycardia and Acute Ischemia
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code number3163 K1-200-WW
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot Available
    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 SponsorWyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
    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 nameGAP-486
    D.3.2Product code ZP123
    D.3.4Pharmaceutical form 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 INNNot Available
    D.3.9.1CAS number Not Assigned
    D.3.9.2Current sponsor codeGAP-486
    D.3.9.3Other descriptive nameWAY-214486
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboInjection*
    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
    Subjects with coronary artery disease or left ventricular dysfunction experiencing an acute coronary syndrome with non-life-threatening ventricular arrhythmias.
    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
    To test the hypothesis that administration of GAP-486 is effective in decreasing the number of non-life-threatening ventricular arrhythmias in subjects who have acute coronary syndrome (unstable angina, ST segment elevated myocardial infarction [STEMI] or myocardial infarction without ST elevation [NSTEMI] subjects).
    E.2.2Secondary objectives of the trial
    To assess safety and tolerability in subjects with acute coronary syndrome.To assess the dose-range and identify potentially effective doses for phase 3 studies.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Men and surgically sterile or postmenopausal women 18 through 95 years of age. Postmenauposal women: at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH level > 40mIU/mL or at least 6 weeks postsurgical bilateral oophrectomy (with or without hysterectomy).
    - Subjects must fulfill clinical criteria for an acute ischemic event.
    - Subjects must have experienced at least 1 episode of non-sustained ventricular tachycardia (NSVT) or a self-terminating episode of sustained ventricular tachycardia before the 3-hour baseline Holter monitor is started.
    - Subjects will have test article within 36 hours from the episode of ischemia.
    E.4Principal exclusion criteria
    -Subjects for whom percutaneous coronary intervention (PCI), thrombolytics, or CABG is anticipated during the 24-hour on-therapy phase of the study. However, revascularization procedures must not be delayed or withheld for the purposes of qualifying for or participating in the study.
    -Subjects who have had previous PCI, treatment with thrombolytics, CABG, or other cardiac surgeries within 24 hours prior to screening.
    -Subjects for whom (at the time of enrollment) cardiac angiography or stress testing is planned during the 24-hour on-therapy phase of the study.
    -Any antiarrhythmics (with the exception of beta blockers) given within 5 half-lives of the start of the 24-hour on-therapy phase of the study.
    -Subjects with cardiogenic shock
    -Subjects with acute pulmonary edema who do not respond immediately to diuretic treatment.
    -Documented history of torsade de pointes.
    -Known congenital long QT syndrome.
    -QTc > 0.50 second at screening.
    -Bradycardia < 40 beats per minute for > 1 minute or sinus pauses > 3 seconds while awake which occur anytime during the 30 minutes prior to test article administration.
    -Subjects with New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF).
    -Presence of or immediate need for continuous ventricular demand pacemaker.
    -Known significant hepatic dysfunction unrelated to the acute ischemic event or renal dysfunction
    -Subjects with hypokalemia at the time of Holter monitor placement.
    -Subjects with new onset atrial fibrillation of < 1 month duration or subjects with unknown duration of atrial fibrillation are excluded. However, if a subject has a negative transesophageal echo or is known to have chronic atrial fibrillation > 1 month and has been receiving anticoagulants for > 1 month, and meets all the inclusion/exclusion criteria, they are eligible to participate in the study.
    -Subjects with Wolff-Parkinson-White syndrome
    -Current use of investigational device or use of investigational drug within 30 days before entry into the study.
    -Subject who previously received test article in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Total number of ventricular arrhythmia beats (the sum of ventricular arrhythmia beats from premature ventricular contractions, couplets, and individual beats in each NSVT and sustained VT episode [see section 6.0 of the Protocol for definitions]) recorded by Holter monitoring during the 24-hour on-therapy phase.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    Third-party unblinded and dose ranging
    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
    Enrollment rate achieved or if interim analysis provides results raising safety concerns
    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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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 Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 500
    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 Decision2005-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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