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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2006-000038-11
    Sponsor's Protocol Code Number:RA/PR/033012/002/05
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-07
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-000038-11
    A.3Full title of the trial
    EVALUATION OF THE EFFICACY, SAFETY AND TOLERABILITY OF THE CONCURRENT ADMINISTRATION OF CHF 4226 HFA pMDI AND EXTRAFINE BUDESONIDE HFA pMDI, BOTH GIVEN ONCE OR TWICE DAILY (2μg + 200μg qd or 1μg + 100μg bid) OVER AN 8-WEEK RANDOMIZED DOUBLE-BLIND TREATMENT PERIOD IN ADULT PATIENTS WITH MODERATE PERSISTENT ASTHMA AND PRESENTING WITH SYMPTOMS ON EXISTING INHALED CORTICOSTEROID THERAPY.
    A.4.1Sponsor's protocol code numberRA/PR/033012/002/05
    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 SponsorCHIESI Farmaceutici S.p.A
    B.1.3.4CountryItaly
    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 nameCHF 4226 HFA pMDI
    D.3.2Product code CHF 4226 HFA
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarmoterol hydrochloride
    D.3.9.1CAS number 137888-11-0
    D.3.9.2Current sponsor codeCHF 4226
    D.3.9.3Other descriptive nameTA 2005
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarmoterol hydrochloride
    D.3.9.1CAS number 137888-11-0
    D.3.9.2Current sponsor codeCHF 4226
    D.3.9.3Other descriptive nameTA 2005
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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 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 nameExtrafine Budesonide HFA pMDI
    D.3.2Product code BUD-EF HFA
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.9.2Current sponsor codeCHF 1536
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.9.2Current sponsor codeCHF 1536
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 namePulmicort Turbuhaler
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBudesonide
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    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 placeboPressurised inhalation, solution
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPressurised inhalation, solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate persistent asthma sub optimally controlled on existing therapy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary:

    To demonstrate the non inferiority in terms of morning PEF of the "free combination" of CHF 4226 HFA pMDI + extrafine budesonide HFA pMDI given once daily in the evening (2µg + 200µg qd) versus CHF 4226 HFA pMDI + extrafine budesonide HFA pMDI given twice daily (1µg + 100µg bid).

    E.2.2Secondary objectives of the trial
    Secondary:

    To demonstrate the superiority of both "free combination" regimens over the Inhaled CorticoSteroid [ICS] monotherapy [Budesonide Turbuhaler];

    Evaluation of the other lung function endpoints (FEV1, FCV, FEF25-75), effect on asthma symptoms, rescue salbutamol use;

    To monitor for safety and tolerability.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients will be enrolled at Visit 1 into the run-in period if they meet all of the following criteria:

    Written informed consent obtained;

    Male or female patients aged > or equal to 18 years;

    Moderate persistent asthma according to the GINA 2004 “Classification of Asthma Severity by Daily Medication Regimen and Response to Treatment”, sub-optimally controlled on existing therapy;

    Patients free of long-acting beta2 agonists treatment (LABAs) at least for 4 weeks before the screening visit and already treated for at least 1 month with inhaled corticosteroids at a stable dose corresponding to mild asthma severity (GINA 2004) (up to 500µg BDP CFC or equivalent);

    Asthma not adequately controlled on existing therapy, defined as presence of asthma symptoms > once a week and nocturnal asthma symptoms > twice a month. These findings are to be confirmed at the end of the run-in period, taking into consideration the patient's recent medical history;

    Forced expiratory volume in the first second (FEV1) > or equal to 60% and < 80% of predicted for the patient normal value;

    Positive FEV1 reversibility test at the screening visit, defined as an increase of at least 15% and at least 200 mL from pre-dose value in FEV1 30 minutes following 4 puffs (4 x 100 µg) of inhaled salbutamol pMDI;

    A documented FEV1 positive reversibility test as above, is acceptable if performed within 6 months of the screening visit ;

    Non-smokers or ex-smokers with cumulative tobacco exposure < 5 pack-years [e.g. less than 1 pack cigarettes (i.e. 20 cigarettes) per day for 5 years or 2 packs cigarettes per day for 2.5 years] and who have stopped smoking for at least 1 year;

    A co-operative attitude and ability to be trained to correctly use the pMDI and Turbuhaler®.

    E.4Principal exclusion criteria
    Patients will not be enrolled at Visit 1 into the run-in period if they meet one or more of the following criteria:

    Inability to carry out pulmonary function testing;

    Diagnosis of COPD as defined by the current GOLD guidelines;

    History of near fatal asthma;

    History of significant seasonal variation of asthma;

    Asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks or during the run-in period (e.g. oral corticosteroids intake, antibiotics);

    Patients presenting with 3 or more asthma exacerbations in the previous 6 months;
    Hospitalization due to asthma during the previous 8 weeks;

    Patients who have been treated with oral or intravenous corticosteroids in the past 4 weeks or depot injectable corticosteroids in the past 8 weeks or during the run-in period;

    Patients who have changed their dose or formulation of their inhaled corticosteroids during the previous 4 weeks or during the run-in period;

    Patients who have been treated with a short-acting β2-agonist in the past 8 hours;

    Patients who have been treated with an oral β2-agonist in the past 4 weeks;

    Patients who have been treated with nebulized β2-agonists, nebulized corticosteroids, inhaled anticholinergics, leukotriene modifiers, xanthine derivatives (e.g. theophylline any formulation) in the past 4 weeks or during the run-in period;

    Patients who have been treated with sodium cromoglycate or nedocromil sodium in the past 12 hours or during the run-in period;

    Patients who have been treated with an inhaled combination drug (eg Seretide®, Symbicort®, Duovent®, Berodual®) in the past 4 weeks or during the run-in period;
    History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiovascular disease;

    Patients with a QTc interval (Bazett’s formula) in the ECG test > 450 msec in males or > 470 msec in females;

    Patients with serum potassium < 3.5mEq/L or > 6.0mEq/L;

    Clinically significant or unstable concomitant disease : e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant pulmonary disease (e.g. tuberculosis, lung cancer or other); gastrointestinal disease (e.g. active peptic ulcer or other); neurological disease; haematological disease; autoimmune disorders or other;

    Cancer or any other chronic disease with poor prognosis and /or affecting patient status;

    Pregnant or lactating females or females at risk of pregnancy, who are not making use of an effective contraceptive method. A pregnancy test will be performed at screening in women of childbearing potential;

    Patients who have been treated with monoamine oxidase inhibitors, tricyclic antidepressants, Selective Serotonin Re Uptake Inhibitors (SSRIs), long-acting antihistamines or beta-blockers in the past 48 hours or during the run-in period (if the patient is on a short acting antihistamine or SSRI treatment, she/he can be included in the study under the following 2 conditions : (i) a recent ECG while patient was on therapy with these medications demonstrate that the QTc interval is in normal range;(ii) these therapies are taken in an unchanged dose throughout the duration of the study);

    Allergy, sensitivity or intolerance to study drug formulation or excipients;

    Patients unlikely to comply with the protocol or unable to understand the nature, scope of the study but also the possible benefits or unwanted effects of the study treatments;

    Patients who received any investigational new drug, or participated in a clinical study within the last 8 weeks;

    E.5 End points
    E.5.1Primary end point(s)
    Primary variables:

    Morning PEF (L/min) measured daily with the electronic peak flow meter (mean of at least 7 values obtained during the last 14 days of the treatment period).

    Secondary variables:

    Morning and evening PEF (L/min) measured with the electronic peak flow meter in the last 14 days before each clinic visit;

    FEV1 (L) , FVC (L), FEF25-75 (L/s) measured at clinic at each visit;
    Day and night asthma symptoms scores;

    Percentage of nights and / or days free of symptoms;

    Salbutamol rescue use;

    Asthma control.
    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 Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    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) Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    double-dummy, open label active treatment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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
    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 months7
    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 months7
    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 Information not present in EudraCT
    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 2006-06-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 304
    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)
    Patients will be returned to appropriate medicinal treatment for asthma, under the supervision of the clinican responsible for their ongoing medical care
    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 Decision2006-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-28
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