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    Summary
    EudraCT Number:2013-000116-14
    Sponsor's Protocol Code Number:M-40464-39
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-11
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-000116-14
    A.3Full title of the trial
    A RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY AND TOLERABILITY OF TWICE-DAILY ACLIDINIUM BROMIDE /FORMOTEROL FUMARATE COMPARED WITH TWICE-DAILY SALMETEROL/FLUTICASONE PROPIONATE FOR 24-WEEKS TREATMENT IN SYMPTOMATIC PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A CLINICAL STUDY TO COMPARE TWO DRUGS: ACLIDINIUM
    BROMIDE/FORMOTEROL FUMARATE (treatment 1) COMPARED WITH
    SALMETEROL/FLUTICASONE PROPRIONATE (treatment 2) FOR 24-WEEKS
    TREATMENT IN SYMPTOMATIC PATIENTS WITH CHRONIC OBSTRUCTIVE
    PULMONARY DISEASE (COPD). THE STUDY IS "RANDOMISED" (EQUAL
    CHANCE OF RECEIVING TREATMENT 1 or TREATMENT 2) AND "DOUBLE
    BLIND" (NEITHER PATIENTS NOR THE STUDY DOCTOR WILL KNOW THE
    TREATMENT)"
    A.4.1Sponsor's protocol code numberM-40464-39
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorALMIRALL, S. A., Research and Development (R&D) Centre
    B.1.3.4CountrySpain
    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 supportAlmirall S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlmirall S.A.
    B.5.2Functional name of contact pointIgnacio Sáez
    B.5.3 Address:
    B.5.3.1Street AddressLaureà Miró 408-410
    B.5.3.2Town/ citySant Feliu de Llobregat, Barcelona
    B.5.3.3Post code08980
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932913716
    B.5.5Fax number+34932913531
    B.5.6E-mailignacio.saez@almirall.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 No
    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 nameAclidinium bromide/Formoterol Fumarate 400/12 µg fixed-dose combination
    D.3.2Product code LAS40464
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    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 INNACLIDINIUM BROMIDE
    D.3.9.1CAS number 320345-99-1
    D.3.9.2Current sponsor codeLAS34273
    D.3.9.4EV Substance CodeSUB71687
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFormoterol
    D.3.9.1CAS number 183814-30-4
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE DIHYDRATE
    D.3.9.4EV Substance CodeSUB25660
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 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 Yes
    D.2.1.1.1Trade name Seretide Accuhaler
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK Ltd, trading as Allen & Hanburys Stockley Park West
    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.3.1Product nameSeretide Accuhaler 50 µg /500 µg
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    D.3.4.1Specific paediatric formulation No
    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 INNSalmeterol
    D.3.9.1CAS number 94749-08-3
    D.3.9.3Other descriptive nameSALMETEROL XINAFOATE
    D.3.9.4EV Substance CodeSUB04314MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluticasone
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder
    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 placeboInhalation powder
    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
    Chronic obstructive pulmonary disease (COPD)
    E.1.1.1Medical condition in easily understood language
    COPD is a chronic lung disease that causes shortness of breath and coughing.
    A bronchodilator helps to open your airways and makes it easier to get air in and out of the lungs.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the long term bronchodilator efficacy of Aclidinium bromide/Formoterol fumarate, administered twice a day, compared to Salmeterol/Fluticasone propionate (SeretideTM AccuhalerTM) in symptomatic COPD patients.

    2. To compare the benefits of Aclidinium bromide/Formoterol fumarate, administered twice a day, versus twice-daily regimen of SeretideTM AccuhalerTM in disease-related health status and COPD symptoms.

    3. To evaluate the long term safety and tolerability of Aclidinium bromide/Formoterol fumarate, administered twice a day, compared to twice daily SeretideTM AccuhalerTM in the same target population.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An additional 12-h serial spirometry sub-study to be conducted for a sub-group of 20% of patients at selected sites.
    E.3Principal inclusion criteria
    For inclusion and randomisation in the trial, patients must meet each of the following criteria at Screening Visit (Visit 1) and at Visit 2 prior to randomisation.

    1. Adult male or non-pregnant, non-lactating female aged ≥ 40. Women of childbearing potential will follow specific study requirements.

    Explanatory note: A female is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year post-menopausal or has undergone tubal ligation. Women of childbearing potential are allowed to enter the trial if they show to have a negative serum pregnancy test at the Screening Visit (Visit 1) and are using, during the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal intra uterine devices (IUDs), sexual abstinence or vasectomy of the partner.

    2. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years.

    Explanatory note: Ex-smoker definition includes those patients who quit smoking more than 6 months prior to the Screening Visit. Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-year history). When the patient has been smoker during several periods of time separated by inactivity periods, the total pack years resulting from several periods of smoking will be added up.

    Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion as well.

    3. Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post bronchodilator FEV1 <80%, and FEV1/FVC < 70% at Screening Visit (Visit 1).

    Explanatory note: Predicted normal values to be used for calculation purposes are to be based on European Community for Steel and Coal predicted values (Quanjer et al. 199320). (i.e., 100xpost-salbutamol FEV1/FVC <70%).

    4. Symptomatic patients with a CAT≥10 at Screening and Randomisation Visit (Visit 1 and 2)
    Explanatory note: CAT questionnaire cannot be repeated.

    5. Patient must be able to perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visit.

    6. Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.
    E.4Principal exclusion criteria
    For inclusion and randomisation in the trial, patients must NOT meet any of the following criteria at Screening Visit (Visit 1) and at Visit 2 prior to randomisation.

    1. History or current diagnosis of asthma.

    2. Patients who develop a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit (Visit 1) or during the run-in period.

    3. Clinically significant respiratory conditions

    Explanatory note: Clinically significant respiratory conditions, some examples are:

    -Known active tuberculosis or pulmonary hypertension.

    -History of interstitial lung disorder: Exposure related interstitial lung disease; isease associated interstitial lung disease; Interstitial lung disease of distinct or unknown cause/pathology.

    -History of massive pulmonary thromboembolic disease.

    -History of lung lobectomy, lung volume reduction or lung transplantation

    -Patients who in the investigator’s opinion may need thoracotomy or other lung surgery during the trial.

    -History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc).

    -Known a1-antitrypsin deficiency

    4. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.

    5. Patient who in the investigator’s opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit.

    6. Use of long-term oxygen therapy (≥ 15 hours/day).

    7. Patients treated on daily basis with triple therapy (LABA+LAMA+ICS) within 4 weeks prior to the Screening Visit.

    8. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers.

    Explanatory note: Patients with symptomatic sleep apnoea syndrome, any disease related with sleep disturbances such as restless-legs syndrome or somnambulism are to be excluded. However the use of continuous positive airway pressure (CPAP) is not an exclusion criteria.

    9. Clinically significant cardiovascular conditions.

    Explanatory note: Clinically significant cardiovascular conditions, some examples are:

    -Myocardial infarction within the 6 months prior to Screening Visit (Visit 1)

    -Unstable angina or unstable arrhythmia meaning which has required changes in the pharmacological therapy or other intervention within 12 months prior to Screening Visit (Visit 1), or newly diagnosed arrhythmia within the previous 3 months prior to Screening Visit (Visit 1).

    -Hospitalisation within 12 months prior to Screening Visit (Visit 1) for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the NYHA.

    10. Patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ECG parameters or in the physical examination at the Screening Visit (Visit 1)

    11. Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm).

    12. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.
    Explanatory note: Patients with well-controlled, stable, asymptomatic benign prostatic hypertrophy are not excluded.

    13. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.

    14. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer.

    Explanatory note: Patients are excluded whether or not there is evidence of local recurrence or metastases

    15. Patient with any other serious or uncontrolled physical or mental dysfunction.

    16. Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment.

    17. Patient unlikely to be cooperative or that can’t comply with the study procedures.

    18. Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening Visit.

    19. Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication.

    20. Any other conditions that, in the investigator’s opinion, might indicate the patient to be unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    Peak FEV1 at week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to point E.5.1
    E.5.2Secondary end point(s)
    TDI focal score at week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to point E.5.2
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA139
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Lithuania
    Netherlands
    Poland
    South Africa
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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 years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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.1.2.1Number of subjects for this age range: 545
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 355
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 668
    F.4.2.2In the whole clinical trial 900
    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)
    Once the last IMP dose is taken (Visit 5 or Premature Discontinuation Visit) and related trial measurements are completed, patient should be instructed by the research personnel to continue to take their usual medications and may resume other medications interrupted prior to trial enrolment as deemed appropriate by the investigator.
    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 Decision2013-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-04
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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