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    Summary
    EudraCT Number:2011-001524-38
    Sponsor's Protocol Code Number:M/40464/30
    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:2011-07-20
    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 number2011-001524-38
    A.3Full title of the trial
    EFFICACY AND SAFETY OF ACLIDINIUM BROMIDE/FORMOTEROL FUMARATE FIXED-DOSE COMBINATIONS COMPARED WITH INDIVIDUAL COMPONENTS AND PLACEBO WHEN ADMINISTERED TO PATIENTS WITH STABLE CHRONIC OBSTRUCTIVE PULMONARY DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term efficacy and safety of aclidinium/formoterol Fixed-Dose Combination
    A.4.1Sponsor's protocol code numberM/40464/30
    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.
    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 AddressLaureano Miró 408-410,
    B.5.3.2Town/ citySant Feliu de Llobregat
    B.5.3.3Post code08980
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 932913716
    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 and Formoterol
    D.3.9.2Current sponsor codeLAS40464
    D.3.9.3Other descriptive nameAclidinium Bromide/Formoterol Fumarate fixed dose combination
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400/12
    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 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 400/6 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 and Formoterol
    D.3.9.2Current sponsor codeLAS40464
    D.3.9.3Other descriptive nameAclidinium Bromide/Formoterol Fumarate fixed dose combination
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400/6
    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 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 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 400 μg
    D.3.2Product code LAS34273
    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.3.9.3Other descriptive nameAclidinium Bromide
    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) 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 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 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 nameFormoterol fumarate 12 μg
    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 INNFormoterol fumarate
    D.3.9.1CAS number 183814-30-4
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Obstructive Pulmonary Disorder
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disorder
    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
    - To assess the long-term bronchodilation of aclidinium/formoterol fixed dose combinations compared to individual components and placebo, when administered twice daily via inhalation to COPD patients.
    - To assess the benefits of aclidinium/formoterol fixed dose combinations in COPD symptoms, disease-related health status and COPD exacerbations compared to individual components and placebo, when
    administered twice daily via inhalation to COPD patients.
    - To evaluate the long-term safety and tolerability of aclidinium/formoterol fixed dose combinations compared to individual components and placebo when administered twice daily via inhalation to COPD patients.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    2011-04-28. Final

    A subset of 20% of the total patients will have 24-hour ECG Holter recording at Screening Visit and at 12 and 24 weeks on study treatment.

    In a different subset of 20% of total patients, additional spirometry assessments will be performed at Randomisation Visit and at 12 and 24 weeks on treatment.
    E.3Principal inclusion criteria
    1. Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential are
    allowed to enter the trial if they show to have a negative serum pregnancy test at the Screening
    Visit 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 IUDs, sexual
    abstinence or vasectomy of the partner.
    (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).
    2. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years.
    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).
    (Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion
    as well).
    3. Patient with a clinical diagnosis of stable COPD according to the GOLD Guidelines at the
    Screening Visit (http://www.goldcopd.org).
    4. Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation
    of 400 μg of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
    5. Patient with a diagnosis of moderate to severe COPD according to the GOLD Guidelines
    classification (stages II and III) at the Screening Visit: FEV1 measured between 10-15 minutes
    post inhalation of 400 μg of salbutamol is 30% ≤ FEV1 < 80% of the predicted normal value (i.e.,
    100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).
    (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. 199324)).
    6. Patient must be able to perform repeatable pulmonary function testing for FEV1 according to
    ATS/ERS 2005 criteria at Screening Visit.
    E.4Principal exclusion criteria
    1. History or current diagnosis of asthma.
    2. Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the
    6 weeks before Screening Visit.
    3. Patient hospitalised for COPD exacerbation within 3 months prior to Screening Visit.
    4. Clinically significant respiratory conditions defined as:
    • Known active tuberculosis.
    • History of interstitial lung or massive pulmonary thromboembolic disease.
    • Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening
    Visit.
    • History of 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.
    6. Use of long-term oxygen therapy (≥ 15 hours/day).
    7. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift
    workers (e.g., history of sleep apnoea syndrome, any disease related with sleep disturbances
    such as restless-legs syndrome or somnambulism).
    8. Clinically significant cardiovascular conditions defined as:
    • Myocardial infarction within the 6 months prior to Screening Visit.
    • Thoracic surgery within 12 months prior to Screening Visit.
    • Unstable angina or unstable arrhythmia meaning which has required changes in the
    pharmacological therapy or other intervention within 12 months prior to Screening Visit, or
    newly diagnosed arrhythmia within the previous 3 months prior to Screening Visit.
    • Hospitalisation within 12 months prior to Screening Visit 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 New York Heart Association.
    10. Patient with QTc [calculated according to Bazett formulae (QTc=QT/RR1/2) > 470 msec as
    indicated in the centralised reading report assessed at Screening Visit.
    11. Patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ECG
    parameters (other than QTc Bazzet) or in the physical examination at the Screening Visit, if the
    abnormality defines a disease state listed as exclusion criteria, except for those related to COPD.
    12. Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic
    amines, or inhaled medication or any component thereof (including report of paradoxical
    bronchospasm). Patient with known narrow-angle glaucoma, symptomatic bladder neck
    obstruction or acute urinary retention.
    13. Patient with symptomatic non-stable prostatic hypertrophy. (However, patients with wellcontrolled,
    stable, asymptomatic benign prostatic hypertrophy are not excluded).
    20. Patient unable to properly use a dry powder (DPI) or pressured metered-dose inhaler (pMDI)
    inhaler device or to perform spirometry measurements.
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary efficacy variables (at Week 24 on treatment):
    - Change from baseline in morning pre-dose (trough) FEV1 of each aclidinium/formoterol
    FDC dose compared to formoterol monotherapy 12 μg.
    - Change from baseline in 1-hour post-morning dose FEV1 of each aclidinium/formoterol FDC
    dose compared to aclidinium monotherapy 400 μg.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 24 on treatment
    E.5.2Secondary end point(s)
    - Improvement of TDI focal score of each aclidinium/formoterol FDC dose compared to
    placebo.
    - Change from baseline in SGRQ total score of each aclidinium/formoterol FDC dose
    compared to placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 24 on treatment
    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 Yes
    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) 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 trial5
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA175
    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
    Belgium
    Bulgaria
    Croatia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    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
    Last patient last visit
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 832
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 901
    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 state88
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1280
    F.4.2.2In the whole clinical trial 1733
    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)
    Resume medication taken by patient prior to study entry or any other as deemed appropriate and patient will be deferred to his/her family doctor.
    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 Decision2011-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-04
    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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