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    Summary
    EudraCT Number:2010-021215-16
    Sponsor's Protocol Code Number:H9P-MC-LNBQ
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-03
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2010-021215-16
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 12 mg to 18 mg Once Daily and LY2216684 Fixed-Dose 6 mg Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Flexible or Fixed Dose LY2216684 as Adjunctive Treatment for Patients With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment
    A.4.1Sponsor's protocol code numberH9P-MC-LNBQ
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01187407
    A.5.4Other Identifiers
    Name:H9P-MC-LNBQNumber:12182
    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 SponsorEli Lilly and Company
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointCarly Anderson
    B.5.3 Address:
    B.5.3.1Street AddressErl Wood Manor
    B.5.3.2Town/ cityWindlesham, Surrey
    B.5.3.3Post codeG420 6PH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441276 483162
    B.5.5Fax number+441256 48337
    B.5.6E-mailandersonca@lilly.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 nameLY2216684
    D.3.2Product code LY2216684
    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 INNINN not yet assigned - LY2216684
    D.3.9.2Current sponsor codeLY2216684
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeNorepinephrine reuptake inhibitor (NERI)
    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 nameLY2216684
    D.3.2Product code LY2216684
    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 INNINN not yet assigned - LY2216684
    D.3.9.2Current sponsor codeLY2216684
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeNorepinephrine reuptake inhibitor (NERI)
    D.IMP: 3
    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 nameLY2216684
    D.3.2Product code LY2216684
    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 INNINN not yet assigned - LY2216684
    D.3.9.2Current sponsor codeLY2216684
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeNorepinephrine reuptake inhibitor (NERI)
    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 placeboTablet
    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 placeboTablet
    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
    Major depressive disorder (MDD)
    E.1.1.1Medical condition in easily understood language
    Mental disorder causing a pervasive depressed mood.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess whether LY2216684 (12-mg to 18-mg flexible dose once daily [QD]) is superior to placebo QD in the adjunctive treatment of patients with major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI), during an 11-week, double-blind, acute adjunctive treatment period. Superiority is defined as a statistically greater reduction in depressive symptoms from baseline to the last visit in the adjunctive treatment phase, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
    E.2.2Secondary objectives of the trial
    - to assess whether LY2216684 12 mg to 18 mg QD is superior to placebo in improving global functioning
    - to assess whether LY2216684 12 mg to 18 mg QD is superior to placebo in
    improving the experience of fatigue
    - to assess whether LY2216684 12 mg to 18 mg QD is superior to placebo in achieving remission at the last visit in the adjunctive treatment phase
    - to assess whether LY2216684 12 mg to 18 mg QD is superior to placebo in achieving remission at least at the patient’s last 2 consecutive visits in the adjunctive treatment period.
    - to assess whether LY2216684 12 mg to 18 mg QD is superior to placebo in improving the impact of fatigue on functioning
    - to assess whether LY2216684 12 mg to 18 mg QD is superior to placebo in improving anxiety symptoms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Meet criteria for primary MDD, as defined by DSM-IV-TR criteria, as determined by
    clinical assessment and confirmed by the MINI at Visit 1.
    [2] Are adult male or female outpatients at least 18 years of age or older at the time of informed consent, who provide informed consent by signing the appropriate ICFs.
    Patients must be competent and able to give their own informed consent.
    [3] Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) may participate in the study. Women must test negative for pregnancy at the time of study entry based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of investigational product. Men participating agree to use a reliable method of birth control during the study.
    [4] Are being treated with one of the following SSRIs that have been approved for MDD treatment within the participating country: escitalopram, citalopram, sertraline,
    fluoxetine, paroxetine, and fluvoxamine; and have been treated with their SSRI at least 6 weeks prior to Visit 2 with at least the last 4 consecutive weeks at a stable optimized dose prior to Visit 2. The SSRI should be prescribed, including dose, in a manner consistent with labeling guidelines within the participating country.
    [5] Meet criteria for partial response at Visit 1 and Visit 2, as defined by investigator’s
    opinion that the patient has experienced a minimally clinically meaningful improvement with the SSRI treatment.
    [6] Have a GRID-HAMD17 total score ≥16 at Visit 1.
    [7] Have ≤75% improvement on the current SSRI at Visit 1, determined by the
    MGH-ATRQ-Modified Version.
    [8] Have an education level and a degree of understanding such that the patient can
    communicate with the site study personnel.
    [9] Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations required by the protocol.
    E.4Principal exclusion criteria
    [10] are investigator site personnel directly affiliated with this study and/or their
    immediate families. Immediate family is defined as a spouse, parent, child, or
    sibling, whether biological or legally adopted.
    [11] are Lilly employees.
    [12] are currently enrolled in, or discontinued within the last 30 days from, a clinical study involving an investigational drug or device or off-label use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    [13] have previously completed or withdrawn from this study or any other study
    investigating LY2216684.
    [14] have had or currently have any additional ongoing DSM-IV-TR Axis I condition other than MDD that was considered the primary diagnosis within 1 year of Visit 1.
    [15] have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder [OCD], posttraumatic stress disorder [PTSD], generalized anxiety disorder [GAD], and social phobia, but excluding specific phobias).
    [16] have a current or previous diagnosis of bipolar disorder, schizophrenia, or other
    psychotic disorder.
    [17] have a history of substance abuse within the past 1 year (drug categories defined by DSM-IV-TR), and/or substance dependence within the past 1 year, not including caffeine and nicotine.
    [18] have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol.
    [19] have had a lack of full response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the patient has treatment-resistant depression.
    [20] have a lifetime treatment history of vagal nerve stimulation (VNS), transcranial
    magnetic stimulation (TMS), or psychosurgery.
    [21] have received electroconvulsive therapy (ECT) in the past year.
    [22] are women who are pregnant or breastfeeding.
    [23] are judged, in the opinion of the investigator, to be at serious risk for harm to self or others.
    [24] have a serious or unstable medical illness, including cardiovascular, hepatic,
    respiratory, hematologic, endocrinologic, neurologic disease, renal disease, or clinically significant laboratory or ECG abnormality. Clinically significant lab or ECG
    abnormalities are those which, in the judgment of the investigator, indicate a serious
    medical problem or require significant intervention.
    [25] have any diagnosed medical condition which could be exacerbated by noradrenergic agents, including unstable hypertension or unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitancy or retention.
    [26] have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.
    [27] have a history of any seizure disorder (other than febrile seizures).
    [28] have received treatment with a monoamine oxidase inhibitor (MAOI) within 14
    days prior to Visit 1 or have a potential need to use an MAOI within 3 days after
    discontinuation from the study.
    [29] require psychotropic medication other than sedative/hypnotic medication for
    sleep, as specified in the protocol.
    [30] are taking or have received treatment with any excluded medications within 7
    days prior to Visit 2.
    [31] have a TSH level outside the laboratory-established reference range. Patients
    previously diagnosed with hyperthyroidism or hypothyroidism who have been treated
    with a stable dose of thyroid supplement for at least the past 3 months, and who are
    clinically and chemically euthyroid, will be allowed to participate in the study.
    [32] have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment.
    [33] have initiated psychotherapy, or other nondrug therapies (such as acupuncture
    or hypnosis) within 12 weeks prior to enrollment or at any time during the study. No change in intensity of psychotherapy within the last 6 weeks prior to enrollment or at any time during the study.
    [34] have a positive urine drug screen (UDS) for any substances of abuse at Visit 1.
    Note: A retest may be performed if the UDS is positive for any prescribed substance or if, in the judgment of the investigator, there is an acceptable explanation for the positive result. The results of the retest must be negative at or prior to Visit 2


    E.5 End points
    E.5.1Primary end point(s)
    Reduction in depressive symptoms from baseline to the last visit in the adjunctive treatment phase, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weekly for 11 weeks starting at the enrolment visit (Day 0) for 11 weeks.
    E.5.2Secondary end point(s)
    Please refer to section 6.2.1 of the protocol "Secondary Gatekeeper Objectives", page 20.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints are measured from Day 0 till Week 11. Refer to Protocol Attachment 1 for details (Study Schedule).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Croatia
    Czech Republic
    Finland
    Hungary
    Japan
    Romania
    Slovakia
    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
    End of study is the date of the last visit or last scheduled procedure shown in the
    Study Schedule for the last active patient in the study.
    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 months3
    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 months3
    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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state83
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 1178
    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 Decision2011-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-13
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