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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2015-000500-26
    Sponsor's Protocol Code Number:01-1-101
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2015-12-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-000500-26
    A.3Full title of the trial
    An Open-label, Single Ascending-dose, Pharmacokinetic and Safety Study of Regadenoson (Rapidscan®) in Paediatric Patients with Cardiovascular Conditions and Diseases
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study of the diagnostic drug, Regadenoson, in infants, children and young people suffering from heart conditions and diseases
    A.4.1Sponsor's protocol code number01-1-101
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/256/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRapidscan Pharma Solutions EU Ltd (RPS EU Ltd)
    B.1.3.4CountryUnited Kingdom
    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 supportRapidscan Pharma Solutions EU Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRapidscan Pharma Solutions EU Ltd
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressRegent's Place, 338 Euston Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW1 3BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+440800 652 1395
    B.5.6E-mailmedical.information@rapiscan-mpi.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 Yes
    D.2.1.1.1Trade name Rapiscan 400 microgram solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderRapidscan Pharma Solutions EU Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNregadenoson
    D.3.9.1CAS number 313348-27-5
    D.3.9.3Other descriptive nameRapiscan
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Rapiscan 400 microgram solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderRapidscan Pharma Solutions EU Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNregadenoson
    D.3.9.1CAS number 313348-27-5
    D.3.9.3Other descriptive nameRapiscan
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Rapiscan 400 microgram solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderRapidscan Pharma Solutions EU Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNregadenoson
    D.3.9.1CAS number 313348-27-5
    D.3.9.3Other descriptive nameRapiscan
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Rapiscan 400 microgram solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderRapidscan Pharma Solutions EU Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNregadenoson
    D.3.9.1CAS number 313348-27-5
    D.3.9.3Other descriptive nameRapiscan
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Regadenoson will be used as a pharmacologic stress agent in paediatric patients with cardiovascular problems, undergoing a clinically indicated myocardial perfusion MRI
    E.1.1.1Medical condition in easily understood language
    Regadenoson will be used to study heart problems in children and young adults with existing heart conditions.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10065141
    E.1.2Term Vascular diagnostic procedure
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To characterise the single IV dose PK of regadenoson over a range of doses in three paediatric populations: adolescents aged 12 to <18 years, children aged 2 to <12 years, and infants aged 1 to <24 months;
    - To evaluate the safety and tolerability of a single IV bolus dose of regadenoson in paediatric populations with ages 1 month to <18 years
    E.2.2Secondary objectives of the trial
    - To characterise the single IV dose PD of regadenoson on HR and coronary sinus flow over a range of doses in three paediatric populations: adolescents aged 12 to <18 years, children aged 2 to <12 years, and infants aged 1 to <24 months;
    - To provide dosing recommendations for potential use of regadenoson in paediatric patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients who are clinically indicated to undergo a diagnostic MPI study using cardiac MRI performed in accordance with the institution’s practice for the paediatric age and condition under evaluation;
    2.Male or female, adolescents aged from 12 to <18 years (Part A), children aged from 2 to <12 years (Part B), and infants aged from 1 to <24 months (Part C);
    3.Weight >5th percentile and <95th percentile based on age and gender; and a body mass index (BMI) >5th percentile and ≤90th percentile for age and gender;
    4.Acceptable range for BP (systolic / diastolic mmHg):
    a.For Parts A and B: 85−130/45−90.
    b.For Part C: 80−120/40−80.
    5.Acceptable range for pulse:
    a.For Part A: 55−100 beats per minute (bpm);
    b.For Part B: 60−120 bpm;
    c.For Part C: 70−1640 bpm.
    6.Restriction of dosing with beta blockers (and preferably other cardioactive medications that may impact the ischaemic reaction to stress, e.g., calcium channel blockers, long-acting nitrates, angiotensin-converting-enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], etc.) in accordance with study site’s routine practice for the stress procedure;
    7.Patients and those whose parent(s) or legally authorised representative(s) who, in the Investigator's view, are likely to be compliant and complete the study;
    8.Negative urine pregnancy test at screening and at pre-dose on the dosing day for post-menarchal female patients;
    9.Post-menarchal female patients must be practicing abstinence, or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least one month before being enrolled in the study and for the duration of the study;
    10.Written informed consent and signed age-appropriate paediatric assent (for patients who are able to review and/or read the assent) prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
    E.4Principal exclusion criteria
    1.Exclusions for the use of gadolinium and MRI are:
    a.End stage renal failure (estimated glomerular filtration rate [GFR] <30mL/min/1.73m2);
    b.Metallic implant or device (e.g. non-conditional pacemaker);
    c.Known allergy to magnetic resonance contrast agents;
    2.Exclusion criteria according to the use of general anaesthesia , if being applied;
    3.Allergy or intolerance to adenosine, to any component of the regadenoson formulation, or to aminophylline or to its components (ethylenediamine and theophylline);
    4.In the judgment of the Investigator, any clinically-significant ongoing medical condition (eg myocardial disease, pericardial inflammatory disease, or severe cardiac outflow obstruction, etc.) that might jeopardise the patient’s safety or interfere with the absorption, distribution, metabolism or excretion of the study drug;
    5.Use of any experimental or investigational drug or device within 30 days prior to the first dose of study drug;
    6.Patients with 2nd or 3rd degree AV block or sick sinus syndrome with or without an artificial pacemaker, and/or with unstable angina that has not been stabilised with medical therapy and/or with severe hypotension and/or with decompensated states of heart failure;
    7.Known or suspected bronchoconstrictive and bronchospastic lung disease either being unstable or requiring active treatment (e.g., wheezing noted on physical exam, frequent exacerbations or active treatment with a bronchodilator or corticosteroids);
    8.Abnormal sitting or semi-recumbent resting BP or pulse (bpm) at screening. If, upon repeat assessment, the sitting or semi-recumbent resting BP or pulse (bpm) at screening is normal, the patient may be evaluated further for inclusion in the study;
    9.Dipyridamole use within 48 hours prior to dosing;
    10.Consumption of methylxanthine-containing products such as caffeinated coffee, tea, caffeinated soft drinks, cocoa or chocolate in the 12 hours prior to dosing;
    11.Aminophylline or theophylline use within 24 hours prior to dosing;
    12.History of alcohol abuse or drug addiction, as determined by the Investigator;
    13.Currently smokes more than five cigarettes or equivalent per day, and if eligible for the study, would not be able to abstain from smoking from midnight prior to dosing until the end of the study period.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and Tolerability Endpoints
    Assessments of heart rate, blood pressure and Adverse Events of a single bolus dose of regadenoson in paediatric populations with ages 1 month to <18 years.
    E.5.1.1Timepoint(s) of evaluation of this end point
    HR and supine BP (mmHg) (systolic/diastolic). Additional vital signs should be recorded as clinically indicated.
    Pre and post-dose vital signs will be recorded as follows:
    • Pre-dose: 15 minutes and 5 minutes prior to dosing;
    • Post-dose: 1, 3, 6, 10, 15, 30 minutes and 1, 2, and 4-6 hours post dosing.
    For post dose vital signs recordings, the time windows are as follows: +/- 0 minutes for minutes 0 through 10, +/- 2 minutes for minutes 15 through 30, and +/- 10 minutes for hours 1 through 6.
    Adverse Events will be recorded throughout the trial.
    E.5.2Secondary end point(s)
    Pharmacokinetic (PK) Outcome Measures, namely, the determination of the PK profile of regadenoson.
    Pharmacodynamic (PD) outcome measures: assessment of coronary sinus flow and HR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For PK outcome measures: for Adolescents aged 12 to <18 years (part A), plasma samples for measurement of regadenoson concentrations are collected pre-dose and at 1, 3, 6, 10, 15, 30 minutes, and then 1, 2, and 4-6 hours post dose. For Children aged 2 to <12 years (part B) and Infants aged 1 to <24 months (part C), population PK modelling will be applied. The frequency, time-points, and/or sampling windows of blood draws for PK will be determined after analysis of the data from Part A, and will be adjusted based on the volume of blood allowed to be drawn from patients in each age group.
    For PD outcome measures: assessment of coronary sinus flow and HR.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 54
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 18
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 24
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state54
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-04
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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