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    Summary
    EudraCT Number:2010-019872-65
    Sponsor's Protocol Code Number:MK-0663-108
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-31
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-019872-65
    A.3Full title of the trial
    A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Etoricoxib with naproxen in ankylosing spondylitis
    A.4.1Sponsor's protocol code numberMK-0663-108
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Regional Business Support Center
    B.5.2Functional name of contact pointSteven Hildemann
    B.5.3 Address:
    B.5.3.1Street AddressRichard-Reitzner-Allee 1
    B.5.3.2Town/ cityHaar
    B.5.3.3Post code85540
    B.5.3.4CountryGermany
    B.5.4Telephone number+498962731350
    B.5.5Fax number+49896273192350
    B.5.6E-mailsteven.hildemann@essex.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ARCOXIA
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
    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 nameEtoricoxib
    D.3.2Product code MK-0663
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETORICOXIB
    D.3.9.1CAS number 202409-33-4
    D.3.9.2Current sponsor codeMK-0663
    D.3.9.3Other descriptive name5-Chlor-6′-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3′-bipyridin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ARCOXIA
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
    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 nameEtoricoxib
    D.3.2Product code MK-0663
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETORICOXIB
    D.3.9.1CAS number 202409-33-4
    D.3.9.2Current sponsor codeMK-0663
    D.3.9.3Other descriptive name5-Chlor-6′-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3′-bipyridin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Yes
    D.2.1.1.1Trade name Naprosyn
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited, UK
    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 nameNaprosysn
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNAPROXEN
    D.3.9.1CAS number 22204-53-1
    D.3.9.3Other descriptive name(+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ankylosing Spondylitis (AS)
    E.1.1.1Medical condition in easily understood language
    Ankylosing Spondylitis (AS)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objective 1: To compare the effects of etoricoxib 90 mg once daily to naproxen 1000 mg in the treatment of ankylosing spondylitis as measured by Spinal Pain Intensity (0- to 100-mm VAS, Question 2 of Bath Ankylosing Spondylitis Disease Activity Index, BASDAI) over 6-weeks of treatment in Part I.
    Objective 2: To compare the effects of etoricoxib 60 mg once daily to naproxen 1000 mg in the treatment of ankylosing spondylitis as measured by Spinal Pain Intensity (0- to 100-mm VAS, Question 2 of Bath Ankylosing Spondylitis Disease Activity Index, BASDAI) over 6-weeks of treatment in Part I.
    Objective 3: To evaluate the overall tolerability of etoricoxib (90 mg and 60 mg once daily) in ankylosing spondylitis patients.
    E.2.2Secondary objectives of the trial
    Objective 1: To evaluate the treatment effect between etoricoxib doses (90 mg, 60 mg once daily) on Spinal Pain Intensity (VAS) over 6-weeks of treatment in Part I as assessed by the time-weighted average (TWA) change from baseline.
    Objective 2: To compare the incremental benefit in those who are considered nonresponders to etoricoxib 60 mg in Part I, and who subsequently increase their dose to etoricoxib 90 mg in Part II, to those non-responders on etoricoxib 60 mg in Part I who subsequently remain on etoricoxib 60 mg in Part II as measured by the
    average change from Week 6 to Weeks 10 and 12 in Spinal Pain Intensity (VAS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is male or female, ≥18 years of age on the day of signing informed consent.
    2. Female patients of reproductive potential must demonstrate a serum β-hCG level consistent with a nongravid state at the screening visit (Visit 1) and agree to remain abstinent, use oral, barrier, intramuscular, or implanted contraceptives from Visit 1 until 28 days after the last dose of study medication. Women who are postmenopausal or have had a hysterectomy or bilateral tubal ligation or bilateral oophorectomy are exempt from this requirement. Postmenopausal is defined as no menses for the previous 1 year prior to Visit 1; women with cessation of menses within the previous 1 year prior to Visit 1 must have FSH tested at Visit 1.
    Note: If a patient’s Visit 1 FSH result is not within the postmenopausal range (as defined by the central laboratory), serum β-hCG must be tested based on the blood sample from Visit 1 and urine β-hCG must be tested at Visits 2, 5, 8, and 9 (or discontinuation).
    3. Patient has a definite diagnosis of AS per Modified New York Criteria at Visit 1, including at least 1 of the following clinical criteria documented as being present for >=6 months prior to visit 1:
    a) low back pain and stiffness which improves with exercise, but is not relieved by rest.
    b) limitation of motion of the lumbar spine in both the sagittal and frontal planes.
    c) limitation of chest expansion relative to normal values corrected for age and sex.
    4. Patient has a history of positive therapeutic benefit with NSAIDs and has taken an
    NSAID on a regular basis and at a therapeutic dose level for at least 30 days prior to study enrollment (regular basis is defined as greater than 20 of the previous 30 days, including 7 of the last 10 days).
    5. If patient is currently using a non-study AS therapy other than NSAIDs, patient's approved non-study AS therapy has been at stable dosing relative to Visit 2 for the required time periods listed below AND is not anticipated to undergo a change within the first 6 weeks of the
    protocol. Similarly, patients must not have discontinued such therapy within the timeframe given below:
    Adalimumab 3 months
    Azathioprine 3 months
    Bucillamine 8 weeks
    Cyclosporin A 3 months
    Etanercept 3 months
    Golimumab 3 months
    Hydroxychloroquine 8 weeks
    Infliximab 3 months
    Leflunomide 3 months
    Methotrexate 2 months
    Pamidronate 3 months
    d-Penicillamine 3 months
    Sulfasalazine 6 weeks
    Thalidomide 3 months
    Note: The use of other locally approved AS therapies will be considered on a case-by-case basis and require prior discussion with the SPONSOR (or its delegates) before the patient is enrolled in the study.
    6. Patient has a score on BASDAI Question 2 at Visit 1 that is <77mm
    7. Patient meets Flare Criteria at Visit 2. Patients are assessed after "washout" of prestudy NSAID and must satisfy flare criteria before randomization. The minimum and maximum washout duration depends upon the particular prestudy NSAID
    Flare Criteria: Patients must demonstrate sufficient "flare" or worsening of AS pain defined as a score on BASDAI Question 2 at Visit 2 that is:
    a) >=40 mm, AND
    b) >=30% higher than the BASDAI Question 2 score at Visit 1, AND
    c) >= 12mm higher than the BASDAI Question 2 score at Visit 1.
    E.4Principal exclusion criteria
    1. Patient is legally incompetent (e.g., a minor or mentally incapacitated), or has active psychosis, or significant emotional problems at the time of the study which in the view of the investigator are sufficient to interfere with the conduct of the study.
    2. Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient/subject to participate.
    3. Patient has a concurrent medical/arthritic disease that could confound or interfere
    with evaluation of efficacy including, but not limited to:
    Inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, crystalinduced arthritis, spondyloarthropathy other than AS, DISH (Diffuse idiopathic skeletal hyperostosis)), polymyalgia rheumatica, a history of septic arthritis or intra-articular fracture of the study joint, Wilson’s disease, hemachromomatosis, ochronosis, or primary osteochondromatosis.
    4. Patient has acute peripheral articular disease (defined as onset within 4 weeks prior to study) of an active (painful or swollen) peripheral arthritis (note: hip and shoulder are not considered to be peripheral joints).
    Note: Patients with a history of chronic peripheral arthritis are permitted to enroll into the study provided that spine pain is the primary source of pain.
    5. Patient has a history of gastric or biliary surgery (including gastric bypass surgery), or small intestine surgery that causes clinical malabsorption. Note: Patients who have had gastric banding or patients with cholecystectomy not resulting in malabsorption are allowed to
    participate.
    6. Patient has an active peptic (gastric or duodenal) ulcer or a history of inflammatory bowel disease.
    7. Patient has confirmed medical diagnosis of ischemic heart disease, cerebrovascular disease, or peripheral artery occlusive disease. In countries in which the use of COX-2 inhibitors has not been contraindicated in patients with these conditions, patients can otherwise participate (with the exception of those patients who have undergone coronary artery bypass graft surgery, angioplasty, or had a cerebrovascular accident or transient ischemic attack within the past 6
    months).
    8. Patient has Class II-IV congestive heart failure
    9. Patient has uncontrolled hypertension (systolic >160 mm Hg or diastolic > 90 mm Hg) at Visit 1 or Visit 2. Investigators are encouraged to maximize blood pressure control according to local guidelines. Note: Local product labeling should be followed. In countries where the use of etoricoxib is contraindicated in patients with blood pressure values that are persistently elevated above 140/90 mm Hg, this definition of uncontrolled hypertension should be used. Note: Patients may be rescreened one time if blood pressure at Visit 1 is outside of the ranges
    listed above. Patients must be excluded if blood pressure at Visit 2 is outside of the ranges listed above.
    10. Patient has a history of neoplastic disease; Exceptions: (1) patients with adequately treated basal cell carcinoma or carcinoma in situ of the cervix may participate; (2) patients with other malignancies which have been successfully treated ≥ 5 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening. However, patients with a history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease are ineligible for the study regardless of the time since treatment, and in such cases, no exceptions will apply.
    11. Patient is allergic to, or has a history of a significant clinical or laboratory adverse experience associated with etoricoxib or naproxen or any of their constituents; is allergic to acetaminophen/paracetamol, or has hypersensitivity (e.g., bronchoconstriction in association with nasal polyps) to aspirin or NSAIDs.
    Note: Patients with a history of a potential idiosyncratic allergic reaction (e.g., rash) to a single NSAID in the past but who have tolerated at least 2 other NSAIDs without hypersensitivity reactions may participate.
    12. Patient has a personal or family history of an inherited or acquired bleeding disorder.
    13. Patient has a history of any illness, which in the opinion of the investigator, might
    confound the results of the study or pose additional risk to the patient.
    14. Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last 5 years) of drug or alcohol abuse or dependence.
    15. Patient is considered morbidly obese (defined as having a BMI≥40 kg/m2) and demonstrates significant health problems stemming from their obesity, which would confound study participation or interpretation of study results.
    E.5 End points
    E.5.1Primary end point(s)
    Time weighted average change from baseline in Spinal Pain Intensity (VAS) over 6 weeks in Part I is the primary endpoint of this study. It will be analyzed using an analysis of covariance model (ANCOVA) with factors for treatment group, stratum(presence/absence of chronic peripheral arthritis), and baseline value as a one-degree-of-freedom covariate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessment according to protocol
    E.5.2Secondary end point(s)
    Average change from week 6 in Spinal Pain Intensity (VAS) over weeks 10 and 12 among non-responders.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessment according to 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 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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 trial4
    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 EEA93
    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
    Austria
    Belgium
    Canada
    Colombia
    Czech Republic
    Estonia
    Finland
    France
    Germany
    Hungary
    India
    Mexico
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Taiwan
    United Kingdom
    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
    -
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 605
    F.4.2.2In the whole clinical trial 900
    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 Decision2010-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-12
    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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