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    Summary
    EudraCT Number:2010-023623-26
    Sponsor's Protocol Code Number:C10953/3073
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-28
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-023623-26
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
    Prowadzone metodą podwójnie ślepej próby w grupach równoległych badanie, z kontrolą placebo i z zastosowaniem stałej dawki, które ma na celu ocenę skuteczności i bezpieczeństwa leczenia preparatem armodafinil (150 mg/dzień) jako leczenia wspomagającego u dorosłych z dużą depresją związaną z zaburzeniami dwubiegunowymi I typu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to look at the safety, effectiveness, and tolerability of armodafinil when used with mood stabilizers in subjects with major depression associated with bipolar I disorder.
    Badanie to ma na celu ocenę bezpieczeństwa, skuteczności i tolerancji preparatu armodafinil przyjmowanego wraz z lekami stabilizującymi nastrój przez pacjentów z dużą depresją związaną z zaburzeniami dwubiegunowymi I typu
    A.4.1Sponsor's protocol code numberC10953/3073
    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 SponsorCephalon, 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 supportCephalon, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationi3 Internationa (UK) Ltd
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street Address20 Grenfell Road, Star House
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 1EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+390654540212
    B.5.5Fax number+441628408401
    B.5.6E-mailregopseurope@inventivhealth.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 nameArmodafinil
    D.3.2Product code CEP-10953
    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 INNArmodafinil
    D.3.9.1CAS number 112111-43-0
    D.3.9.2Current sponsor codeCEP-10953
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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 Depression Associated With Bipolar I Disorder
    Duża depresja związana z zaburzeniami dwubiegunowymi I typu
    E.1.1.1Medical condition in easily understood language
    Major Depression Associated With Bipolar I Disorder
    Duża depresja związana z zaburzeniami dwubiegunowymi I typu
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10004911
    E.1.2Term Bipolar affective disorder, depressed
    E.1.2System Organ Class 100000004873
    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 the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder. Efficacy will be assessed by the mean change from baseline in the total score from the 30-Item Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30).
    Pierwszorzędowym celem niniejszego badania jest określenie, czy podawanie armodafinilu,w dawce 150 mg na dobę jest skuteczniejsze niż podawanie placebo jako terapii wspomagającej stosowanie leków normotymicznych w leczeniu osób dorosłych z ciezkim epizodem depresyjnym w przebiegu zaburzenia afektywnego dwubiegunowego typu I. Skuteczność będzie oceniana na podstawie średniej zmiany w stosunku do wartości poczatkowych w całkowitym wyniku TRZYDZIEST-PUNKTOWEJ SKALI OCENY objawow depresji (30-Item Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of armodafinil treatment compared with placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode
    associated with bipolar I disorder.
    • To evaluate the change from baseline in the CGI-S rating for depression at weeks 1, 2, 4, 6, 7, and 8, or last postbaseline observation.
    • To evaluate the efficacy of armodafinil treatment compared with placebo treatment on patient functioning as assessed by the GAF Scale scores at weeks 4 and 8, or last postbaseline observation.
    • To evaluate the safety and tolerability of armodafinil treatment.
    • zbadanie skuteczności podawania armodafinilu w porównaniu z placebo jako terapii wspomagającej u osób dorosłych przeżywających ciezki epizod depresyjny w przebiegu zaburzenia afektywnego dwubiegunowego typu I
    • zbadanie zmiany oceny nasilenia depresji w stosunku do wartości wstępnych za pomocą Clinical Global Impression of Severity (CGI-S) w tygodniach 1, 2, 4, 6, 7 i 8 lub podczas ostatniej obserwacji przeprowadzonej po wizycie wejsciowej
    • zbadanie skutecznosci podawania armodafinilu w porównaniu z placebo na funkcjonowanie pacjenta oceniane na podstawie wyników w skali Global Assessment of Functioning (GAF) w tygodniach 4 i 8 lub podczas ostatniej obserwacji przeprowadzonej po wizycie wejsciowe
    • zbadanie bezpieczeństwa i tolerancji armodafinilu
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are included in the study if all of the following criteria are met:
    (a) The patient has a diagnosis of bipolar I disorder according to the DSM-IV-TR criteria as determined by the SCID-CT and is currently experiencing a major depressive episode.
    (b) The investigator has established, by medical record documentation or by history from the patient and at least 1 reliable informant, that the patient has had at least 1 previous manic or mixed episode, which resulted in functional impairment and was treated (or should have been treated) with a mood stabilizer or antipsychotic medication.
    (c) The patient has had no more than 6 mood episodes in the last year.
    (d) The patient’s current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient’s current mood stabilizer regime began. Date of onset of the current depressive episode must be at least 8 weeks after resolution of any previous mood episode.
    Inclusion criterion (e) was replaced by (e1).
    (e1) The patient must have been taking 1 (or 2) of the following protocol-allowed mood
    stabilizers:
    • lithium
    • valproic acid
    • lamotrigine
    • aripiprazole
    • olanzapine
    • quetiapine
    • risperidone
    • ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine)
    The following criteria must also be met:
    • The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major
    depressive episode and still be taken at the time of the screening visit at dose or blood level
    considered appropriate for maintenance therapy by the patient’s physician.
    • The patient must continue to take the same mood stabilizer(s) during the screening period; no
    mood stabilizer may be added during the screening period.
    • The mood stabilizer(s) must be taken for a minimum of 8 weeks prior to the baseline visit.
    • The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the
    baseline visit. Minimum required dosages and plasma concentrations, if applicable, and the
    lengths of time for these minimum requirements (4 or 8 weeks depending on the medication) are
    provided in the protocol.
    • The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone,
    which can be either in an oral or long-acting injection formulation.
    • The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium,
    valproic acid, or lamotrigine.
    (f) The patient has been on a stable dosage of all other permitted medications (with the exception of medication to be used on an as-needed basis) for 2 weeks prior to the baseline visit.
    (g) The patient has a score of 13 or more on the QIDS-C16 at the screening and baseline visits.
    (h) The patient has a CGI-S rating (for depression) of 4 (moderately ill) or higher at the screening visit and at the baseline visit.
    (i) The patient has a YMRS total score of 10 or less at the screening and baseline visits.
    (j) The patient has a YMRS score of 0 or 1 on items 1 through 3 at the screening and baseline visits.
    (k) Written informed consent obtained.
    (l) The patient is a man or woman 18 through 65 years of age.
    (m) The patient is in good health (except for diagnosis of bipolar I disorder) as judged by the investigator, on the basis of medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, and urinalysis.
    (n) Women of childbearing potential (women who have not reached menopause, women who are less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, intrauterine device, and steroidal contraceptive in conjunction with a barrier method.
    (o) The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
    (p) The patient has permanent accommodations and means of being contacted by the study center.
    (q) The patient understands that they may enroll in this clinical study only once and may not enroll in any other clinical study while participating in this study.
    (r) The patient may temporarily reside in a clinic or hospital, or may currently be treated in an over-night medical facility at the beginning of and throughout the study, in a manner consistent with medical practices as related to the treatment of depression associated with bipolar I disorder.
    E.4Principal exclusion criteria
    (a) The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
    (b) The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
    (c) The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present; or, at any time during the screening period or at baseline has a score of 2 or more for item 18 on the IDS-C30.
    (d) The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.
    (e) The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.
    (f) The patient has a history of alcohol or substance abuse or dependence (with the exception of nicotine dependence) within 3 months of the screening visit or during the screening period.
    (g) The patient has borderline personality disorder or antisocial personality disorder.
    (h) The patient has any other Axis II disorder that could interfere with the conduct of the study.
    (i) The patient has a HAM-A score of 17 or more at the baseline visit.
    Exclusion criterion (j) was replaced by (j1).
    (j1) The patient has a history of any clinically significant cutaneous drug reaction or a history of
    clinically significant hypersensitivity reaction, including multiple allergies.
    (k) The patient has a past or present seizure disorder (except history of a single febrile seizure), or a history of clinically significant head trauma (eg, brain damage) or of brain surgery.
    (l) The patient has left ventricular hypertrophy or the patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome.
    (m) The patient has human immunodeficiency virus (HIV).
    (n) The patient has any clinically significant uncontrolled medical condition, treated or untreated.
    (o) In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination.
    (p) The patient has 1 or more clinical laboratory test values outside the ranges specified in the protocol
    (q) The patient has any other clinically significant laboratory abnormality, without prior written approval by the medical monitor
    (r) The patient has a positive urine drug screen (UDS) for anything other than cannabis unless the investigator and medical monitor agree that there is an adequate medical (therapeutic) explanation and the patient has a negative UDS prior to randomization.
    Patients with a positive result for cannabis may be enrolled at the discretion of the medical monitor if the investigator determines that there is no cannabis abuse (according to DSM-IV-TR criteria). The investigator will also determine that there is no regular use of cannabis and that, after counseling, the patient agrees not to use cannabis during the study. In that case the patient does not have to have a second UDS negative for cannabis before randomization.
    (s) The patient has received modafinil or armodafinil within the past 5 years, or the patient has a known sensitivity to any ingredients in the study drug tablets.
    (t) The patient has previously participated in a clinical study with armodafinil or has used any investigational product within 90 days of screening. The patient may not enroll in any other clinical study while participating in this study.
    (u) The patient has used any medication known to induce metabolism via CYP3A4/5 within 14 days prior to the baseline visit.
    (v) The patient is using any exclusionary medication, or has used exclusionary medication within 14 days or 5 half-lives of the drug and its active metabolites, whichever is longer, of the baseline visit.
    (w) The patient has ever been treated with vagus nerve stimulation or deep brain stimulation, or has been treated with electroconvulsive therapy or repetitive transcranial magnetic stimulation within 3 months of the screening visit.
    (x) The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
    (y) The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
    (z) The patient is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor.
    (aa) The patient is unable to read well enough to complete the interactive computerized depressive symptom interview without assistance. (bb) The patient is an inpatient without consent or is institutionalized for reasons other than the conditions stipulated in inclusion criterion (a)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure and endpoint for this study is the IDS-C30 assessed at all postbaseline visits.
    Pierwszorzędowym wskaźnikiem i punktem końcowym skuteczności w tym badaniu jest wynik IDS-C30 uzyskany podczas wszystkich wizyt po wizycie wstępnej
    E.5.1.1Timepoint(s) of evaluation of this end point
    All postbaseline visits.
    Podczas wszystkich wizyt po wizycie wstępnej
    E.5.2Secondary end point(s)
    The secondary efficacy measures and endpoints are as follows:

    • the IDS-C30
    • CGI-S for depression
    • GAF Scale
    Drugorzędowe wskaźniki i punkty końcowe skuteczności w tym badaniu są następujące:
    • wyniki IDS-C30
    • wyniki CGI-S
    • wyniki w skali GAF
    E.5.2.1Timepoint(s) of evaluation of this end point
    • the IDS-C30 assessed at weeks 1, 2, 4, 6, 7, and 8, or last postbaseline observation
    • CGI-S for depression assessed at weeks 1, 2, 4, 6, 7, and 8, or last postbaseline observation
    • GAF Scale assessed at weeks 4 and 8, or last postbaseline observation

    • wyniki IDS-C30 oceniane w tygodniach 1, 2, 4, 6, 7 i 8 lub podczas ostatniej obserwacji przeprowadzonej po wizycie wejsciowej
    • wyniki CGI-S dla depresji ocenianew tygodniach 1, 2, 4, 6, 7 i 8 lub podczas ostatniej obserwacji przeprowadzonej po wizycie wejsciowej
    • wyniki w skali GAF ocenianew tygodniach 4 i 8 lub podczas ostatniej obserwacji przeprowadzonej po wizycie wejsciowej
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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.8.2.4Number 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Brazil
    Croatia
    Finland
    Germany
    Hungary
    India
    Italy
    Slovakia
    South Africa
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Ostatnia wizyta ostatniego pacjenta
    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 months2
    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 months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 370
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 370
    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)
    Patients who complete the double-blind treatment period may be eligible to enroll in an open-label extension study (eg, study C10953/3074).

    Patients that do not complete the double-blind treatment period, are ineligible for inclusion or decline to pariticpate in the extension study will be treated as per normal standard of care.
    Pacjenci, którzy ukończą leczenie w badaniu prowadzonym metodą podwójnie ślepej próby, mogą zakwalifikować się do włączenia do badania otwartego, będącego przedłużeniem badania głównego (np. C10953/3074).


    Pacjenci, którzy nie ukończą leczenia w badaniu prowadzonym metodą podwójnie ślepej próby, lub
    odmówią uczestnictwa w badaniu będącym przedłużeniem badania głównego będą otrzymywać
    standardową opiekę medyczną.
    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 Decision2012-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-29
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