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    Summary
    EudraCT Number:2012-000525-45
    Sponsor's Protocol Code Number:DB2114930
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-11
    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 ConcernedGreece - EOF
    A.2EudraCT number2012-000525-45
    A.3Full title of the trial
    DB2114930: A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium/vilanterol compared with fluticasone
    propionate/salmeterol over 12 weeks in subjects with COPD.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare umeclidinium/vilanterol compared with fluticasone propionate/salmeterol in COPD
    A.3.2Name or abbreviated title of the trial where available
    Advair v Zephyr
    A.4.1Sponsor's protocol code numberDB2114930
    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 SponsorGlaxoSmithKline Research & Development Limited
    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 supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Limited
    B.5.2Functional name of contact pointGSK Clinical Support HelpDesk
    B.5.3 Address:
    B.5.3.1Street Address1-3 IronBridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402089904466
    B.5.5Fax number+4402089904968
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameUmeclidinium/Vilanterol
    D.3.2Product code GSK573719/GW642444
    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 INNUmeclidinium
    D.3.9.1CAS number 869113-09-7
    D.3.9.2Current sponsor codeGSK573719
    D.3.9.3Other descriptive nameGSK573719
    D.3.9.4EV Substance CodeSUB31865
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVilanterol Trifenatate
    D.3.9.1CAS number 503070-58-4
    D.3.9.2Current sponsor codeGW642444
    D.3.9.3Other descriptive nameVilanterol Trifenatate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Advair
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameFluticasone propionate/salmeterol
    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 INNFluticasone propionate
    D.3.9.2Current sponsor codeFluticasone propionate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsalmeterol
    D.3.9.2Current sponsor codesalmeterol
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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, pre-dispensed
    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, pre-dispensed
    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
    Chronic Obstructive Pulmonary Disease (COPD) which may also be called emphysema or chronic bronchitis
    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
    Compare the efficacy and safety of UMEC/VI Inhalation Powder (62.5/25mcg oncedaily) with fluticasone propionate/salmeterol (250/50mcg twice-daily) over 12 weeks in subjects with COPD who have a history of infrequent COPD exacerbations
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the study must meet all of the following criteria:
    1. Type of subject: Outpatient
    2. Informed Consent: A signed and dated written informed consent prior to study
    participation
    3. Age: Subjects 40 years of age or older at Visit 1
    4. Gender: Male or female subjects.
    A female is eligible to enter and participate in the study if she is of:
    Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, ncluding any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral
    oophorectomy or tubal ligation. Post-menopausal females are defined as being
    amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age
    appropriate, > 45 years, in the absence of hormone replacement therapy. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to follow-up contact):
    • Abstinence
    • Oral Contraceptive, either combined or progestogen alone
    • Injectable progestogen
    • Implants of levonorgestrel
    • Estrogenic vaginal ring
    • Percutaneous contraceptive patches
    • Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP
    effectiveness criteria as stated in the product label
    • Male partner sterilization (vasectomy with documentation of azoospermia) prior
    to the female subject's entry into the study, and this male is the sole partner for
    that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records.
    • Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent
    (foam/gel/film/cream/suppository)
    5. Diagnosis: An established clinical history of COPD in accordance with the definition
    by the American Thoracic Society/European Respiratory Society [Celli, 2004] as follows:
    Chronic obstructive pulmonary disease is a preventable and treatable disease state
    characterized by airflow limitation that is not fully reversible. The airflow limitation
    is usually progressive and is associated with an abnormal inflammatory response of
    the lungs to noxious particles or gases, primarily caused by cigarette smoking.
    Although COPD affects the lungs, it also produces significant systemic consequences.
    6. Smoking history: Current or former cigarette smokers with a history of cigarette
    smoking of ≥10 pack-years [number of pack years = (number of cigarettes per
    day/20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10
    cigarettes per day for 20 years)]. Previous smokers are defined as those who have
    stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot
    be used to calculate pack year history.
    7. Severity of disease: A pre and post-salbutamol FEV1/FVC ratio of <0.70 and a postsalbutamol FEV1 of ≥30% and ≤70% of predicted normal values calculated using
    NHANES III reference equations at Visit 1 [Hankinson, 1999; Hankinson, 2010].
    8. Dyspnea: A score of ≥2 on the Modified Medical Research Council Dyspnea Scale
    (mMRC) at Visit 1.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. Pregnancy: Women who are pregnant or lactating or are planning on becoming
    pregnant during the study
    2. Asthma: A current diagnosis of asthma
    3. Other Respiratory Disorders: Known α-1 antitrypsin deficiency, active lung
    infections (such as tuberculosis), and lung cancer are absolute exclusionary
    conditions. A subject, who, in the opinion of the investigator, has any other
    significant respiratory condition in addition to COPD should be excluded. Examples
    may include clinically significant bronchiectasis, pulmonary hypertension,
    sarcoidosis, or interstitial lung disease. Inactive tuberculosis in more than one lobe is exclusionary. Allergic rhinitis is not exclusionary.
    4. Other Diseases/Abnormalities: Subjects with historical or current evidence of
    clinically significant cardiovascular, neurological, psychiatric, renal, hepatic,
    immunological, endocrine (including uncontrolled diabetes or thyroid disease) or
    hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
    5. Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid,
    lactose/milk protein or magnesium stearate or a medical condition such as narrowangle
    glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic.
    6. Hospitalization: Hospitalization for pneumonia within 12 weeks prior to Visit 1
    7. History of COPD Exacerbation: A documented history of at least one COPD
    exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics, and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence.
    8. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1)
    9. 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by
    a centralized independent cardiologist to assist in evaluation of subject eligibility.
    Specific ECG findings that preclude subject eligibility are listed in Appendix 4 of the protocol.
    (Section 11.4). The study investigator will determine the medical significance of any
    ECG abnormalities not listed in Appendix 4.
    10. Medication Prior to Spirometry: Unable to withhold salbutamol for the 4 hour
    period required prior to spirometry testing at each study visit
    11. Medications Prior to Screening: Use of the following medications according to the
    following defined time intervals prior to Visit 1: (refer to protocol p.25).
    12. Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., ≤12 hours per day) is not exclusionary.
    13. Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol) via nebulized therapy.
    14. Pulmonary Rehabilitation Program: Participation in the acute phase of a
    pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are
    in the maintenance phase of a pulmonary rehabilitation program are not excluded.
    15. Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse
    within 2 years prior to Visit 1.
    16. Affiliation with Investigator Site: A subject will not be eligible for this study if
    he/she is an immediate family member of the participating investigator, subinvestigator, study coordinator, or employee of the participating investigator.
    17. Inability to read: A subject will not be eligible for the study if in the opinion of the
    investigator the subject cannot read.
    E.5 End points
    E.5.1Primary end point(s)
    24-hour weighted-mean FEV1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment Day 84.
    E.5.2Secondary end point(s)
    Trough and Weighted Mean FEV1
    Rescue salbutamol use (percentage of rescue-free days and puffs/day)
    Proportion of subjects achieving an increase in FEV1 of 12% and 200mL above baseline
    Proportion of subjects achieving an increase of 100mL above baseline in trough FEV1
    Peak and serial FEV1
    Serial, trough and weighted mean FVC
    TDI focal score
    inspiratory capacity
    Incidence of adverse events (AEs)
    COPD exacerbations
    Vital signs
    EQ-5D health outcome assessment
    COPD Assessment Test (CAT)
    St. George’s Respiratory Questionnaire for COPD patients (SGRQ-C)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Trough FEV1 on Day 85, defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84.
    Weighted Mean FEV1 over 0-6 hours post-dose on Day 1 Trough FEV1 at Day 28, Day 56, and Day 84 Rescue salbutamol use (percentage of rescue-free days and puffs/day) Proportion of subjects achieving an increase in FEV1 of 12% and 200mL above baseline at any time during 0-6 hours post-dose on Treatment Day 1
    Proportion of subjects achieving an increase of 100mL above baseline in trough FEV1 Peak FEV1 Serial FEV1 over 0 to 6 hours post-dose on Day 1 Serial FEV1 over 0 to 24 hours post-dose on Day 84
    Serial FVC at Day 1 (0-6 hours post-dose) and Day 84 (0-24 hours post-dose)
    Trough FVC at Day 28, Day 56, Day 84 and Day. For further deatils refer to the protocol.
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    DOUBLE DUMMY
    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.8.2.3.1Comparator description
    Seretide
    Advair
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Argentina
    Chile
    Greece
    Peru
    Romania
    Ukraine
    United States
    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 years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 292
    F.4.2.2In the whole clinical trial 710
    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)
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the patient’s medical condition whether or not GSK is providing specific post study treatment.
    There are no plans to provide study medication for compassionate use following study completion. At the end of the treatment period,subjects can resume conventional COPD therapy as prescribed by the investigator. Post-study COPD therapy should not be entered into the eCRF.
    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 Decision2013-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-25
    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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