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    Summary
    EudraCT Number:2010-023001-36
    Sponsor's Protocol Code Number:BAY86-4875/14607
    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:2011-05-23
    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 number2010-023001-36
    A.3Full title of the trial
    Multicenter, open-label study to evaluate the safety and efficacy (by
    blinded reading) of contrast-enhanced magnetic resonance angiography
    (MRA) after a single intravenous injection of 0.1 mmol/kg gadobutrol in
    subjects with known or suspected vascular disease of the supra-aortic
    vessels
    Otwarte, wieloośrodkowe badanie oceniające bezpieczeństwo i skuteczność (poprzez interpretację zaślepionych wyników) angiografii rezonansu magnetycznego ze wzmocnieniem kontrastowym po pojedynczym, dożylnym podaniu 0.1 mmol/kg gadobutrolu u pacjentów z rozpoznaną lub podejrzewaną chorobą naczyniową w obrębie naczyń nadaortalnych.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Contrast-Enhanced MRI of the supra-aortic vessels
    A.3.2Name or abbreviated title of the trial where available
    Gadobutrol-enhanced MRA study of the supra-aortic vessels (GEMSAV)
    Badanie angio-RM naczyń nadaortalnych ze wzmocnieniem kontrastowym gadobutrolem (Gadobutrol Enhanced
    A.4.1Sponsor's protocol code numberBAY86-4875/14607
    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 SponsorBayer Health Care AG
    B.1.3.4CountryGermany
    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 supportBayer Health Care AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Bayer Health Care AG
    B.5.2Functional name of contact pointCTP Team / Ref: "EU CTR" / S102 - R
    B.5.3 Address:
    B.5.3.1Street AddressMüllerstr. 170-178
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post codeD-13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 Yes
    D.2.1.1.1Trade name Gadovist® 1.0
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 nameGadovist® 1.0
    D.3.2Product code BAY 86-4875
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgadobutrol
    D.3.9.1CAS number 138071-82-6
    D.3.9.2Current sponsor codeBAY 86-4875
    D.3.9.3Other descriptive nameGADOBUTROL
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/kg millimole(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with known or suspected vascular disease of the supra-aortic vessels
    Pacjenci z rozpoznaną lub podejrzewaną chorobą naczyń nadaortalnych.
    E.1.1.1Medical condition in easily understood language
    Known or suspected disease of the supra-aortic vessels
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10007687
    E.1.2Term Carotid artery stenosis
    E.1.2System Organ Class 10029205 - Nervous system 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 efficacy evaluation will be based on three primary efficacy variables:
    • Assessability
    • Sensitivity
    • Specificity
    which will be calculated for both gadobutrol-enhanced MRA and non-contrast ToF MRA.
    These will be used to evaluate five co-primary endpoints:
    - Proportion of assessable vascular segments
    - Sensitivity for detection of clinically significant disease [70 to 99%
    stenosis] on a segmental basis
    - Specificity for exclusion of clinically significant disease [70 to 99% stenosis]
    on a segmental basis
    - The two minimum gadobutrol performance criteria:
    Sensitivity > 50%
    Specificity > 50%
    Podstawowe zmienne oceny skuteczności będą dokonana w oparciu o trzy główne zmienne skuteczności:
    - możliwość oceny,
    -czułość,
    -swoistość,
    które będą wyliczane zarówno dla badania angiografii metodą rezonansu magnetycznego (angio-RM )ze wzmocnieniem kontrastowym z zastosowaniem gadobutrolu oraz badania ToF angio-RM.
    Dane te będą użyte do oceny pięciu równorzędnych punktów końcowych:
    - proporcji możliwych do oceny odcinków naczyń krwionośnych,
    - rozpoznawania klinicznie istotnej choroby na podstawie czułości [zwężenie 70-99%] w poszczególnych odcinkach
    - wykluczania klinicznie istotnej choroby na podstawie swoistości [zwężenie 70-99%] w poszczególnych odcinkach
    - dwa kryteria minimalnej skuteczności gadobutrolu:
    - czułość> 50%
    - swoistość >50%
    E.2.2Secondary objectives of the trial
    A further objective of this study is to confirm the safety profile of gadobutrol for this indication.

    The secondary efficacy assessments will include the following:
    • Minimum diameter of the segment
    • Location and length of stenotic segments with ≥ 70% stenosis
    • Secondary radiologic indicators for diagnosis of clinically significant disease
    • Artifacts by type (segmental)
    • Diagnostic confidence (segmental)
    • Additional imaging studies recommended (example: CTA, CE MRA,
    Ultrasound, Nuclear Medicine)
    Dodatkowym celem tego badania jest potwierdzenie profilu bezpieczeństwa gadobutrolu stosowanego w tym wskazaniu.
    Drugorzędowym celem jest ocena skuteczności, która określona będzie na podstawie::
    - minimalnej średnica segmentu
    - lokalizacji oraz długość segmentu ze zwężeniem ≥70 %
    - dodatkowym radiologicznym wskazaniu w diagnozowaniu klinicznie istotnej choroby
    - artefaktów według typu
    - potwierdzenia diagnostycznego
    - zalecenia wykonania dodatkowych badań obrazowych (np. badanie angio-RM z kontrastem, tomografia komputerowa, badanie ultrasonograficzne, badania z zastosowaniem metod medycyny nuklearnej)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subjects, aged 18 years and older
    - Any of the following:
    - Known or suspected supra-aortic arterial disease based on:
    - Prior stroke
    - Transient ischemic attack (TIA)
    - Amaurosis Fugax (transient monocular blindness)
    - Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis)
    - Follow-up for a stent in a supra-aortic vessel
    - Prior imaging study (CTA or ultrasound) showing ≥ 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). The proportion of subjects with positive disease (determined by the investigator, based on CTA or ultrasound) will be monitored during the study, and enrolment may be further restricted to require ≥ 70% stenosis to ensure that overall there are an adequate number of subjects with clinically significant disease for the evaluation of study endpoints
    - Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography [CE MRA] examination with gadobutrol
    - Willingness and ability to follow directions and complete all study procedures specified in the protocol
    - Females of childbearing potential only: Negative pregnancy test on the day of the MRA before the administration of study drug
    1. Mężczyzna lub kobieta w wieku ≥18 lat.
    2. Którekolwiek z poniższych kryteriów
    Rozpoznana lub podejrzewana choroba tętnic nadaortalnych, stwierdzona na podstawie:
    - wcześniejszego udaru,
    - przemijających ataków niedokrwiennych,
    - przejściowych objawów ślepoty,
    - skierowania na badanie naczyń nadaortalnych z powodu klinicznie istotnego
    zwężenia
    - obserwacji metalowego stentu w naczyniach nadaortalnych,
    - wykazanego zwężenia naczyń nadaortalnych ≥50% we wcześniejszym
    badaniu angio-TK lub badaniu ultrasonograficznym (wykonanym w okresie 60 dni przed wyrażeniem zgody).
    Uwaga: Badanie angio-TK musi spełniać wymagania określone w protokole. Jeżeli badanie angio-TK nie będzie spełniało wymagań protokołu, wówczas musi zostać powtórzone jako część badania klinicznego. W przeciwnym razie pacjent nie możne być zakwalifikowany do badania.
    3. Chęć poddania się rutynowemu badaniu angio-RM ze wzmocnieniem kontrastowym przy zastosowaniu gadobutrolu.
    4. Chęć i gotowość uczestnika badania co do przestrzegania otrzymanych instrukcji oraz wszystkich procedur badania określonych w protokole.
    5. W przypadku kobiet w okresie rozrodczym: ujemny wynik testu ciążowego wykonanego w dniu angio-RM przed podaniem badanego preparatu.
    E.4Principal exclusion criteria
    - Pregnant or nursing (including pumping for storage and feeding)
    - Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study
    - Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol
    - Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI)
    - Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF])
    - History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
    - Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.)
    - Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.)
    - Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
    - Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome
    - Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery)
    - Scheduled or potentially expected for the period between the CTA and gadobutrol MRA:
    - Any procedure that may alter the MRA or CTA interpretation, or
    - Any interventional or surgical procedure involving the supra-aortic vessels
    1. Ciąża lub karmienie piersią (włączając odciąganie pokarmu w celu przechowywania i karmienia dziecka).
    2. Otrzymywanie jakiegokolwiek innego produktu o charakterze eksperymentalnym lub udział w jakimkolwiek innym badaniu klinicznym w okresie 30 dni przed włączeniem do tego badania.
    3. Wcześniejszy udział w tym samym badaniu lub w jakimkolwiek innym badaniu z gadobutrolem sponsorowanym przez firmę Bayer.
    4. Przeciwwskazanie do badań RM (np. niezdolność do wstrzymania oddechu, ciężkie zaburzenia rytmu serca, bardzo niska pojemność minutowa, nasilona klaustrofobia, wszczepiony defibrylator lub inne metalowe urządzenia będące przeciwwskazaniem do badania RM).
    5. Przeciwwskazania do stosowania środków kontrastowych zawierających Gd (w tym także pacjenci z potwierdzonym lub podejrzewanym nerkopochodnym zwłóknieniem układowym- NSF).
    6. Stwierdzone ciężkie (w ocenie badacza, z uwzględnieniem nasilenia zdarzenia) reakcje alergiczne lub anafilaktyczne na jakikolwiek alergen, w tym leki i środki kontrastowe.
    7. Otrzymanie jakiegokolwiek środka kontrastowego w okresie 72 godzin przed badaniem angio-RM, bądź zaplanowane badanie wymagające użycia środka kontrastowego w okresie 24 godzin po wykonaniu badania angio-RM (Uwaga: Dotyczy to także procedury angio-TK, która może być potencjalnie zaplanowana w trakcie badania).
    8. Współczynnik przesączania kłębuszkowego(eGFR) < 30 ml/min/1,73 m2, obliczona na podstawie wyniku oznaczenia poziomu kreatyniny w surowicy w okresie 2 tygodni przed podaniem gadobutrolu. Wszyscy pacjenci poddawani hemodializom lub dializom otrzewnowym są wyłączeni z udziału w badaniu. (Jeżeli dostępnych jest kilka wyników oznaczeń kreatyniny, wówczas należy wziąć pod uwagę wartości uzyskane w najkrótszym czasie przed badaniem angio-RM. Nie należy wykorzystywać wyniku z laboratorium centralnego, jeżeli nie jest on dostępny przed wykonaniem angio-RM).
    9. Ostra niewydolność nerek o dowolnym stopniu nasilenia, spowodowana zespołem wątrobowo- nerkowym lub występująca w okresie okołooperacyjnym w związku z przeszczepieniem wątroby.
    10. Potwierdzona ciężka choroba sercowo-naczyniowa (np. ostry zawał serca [< 14 dni], niestabilna dławica piersiowa, zastoinowa niewydolność serca klasy IV [wg. NYHA]), bądź rozpoznanie zespołu wydłużonego odcinka QT.
    11. Spodziewana niestabilność kliniczna lub nieprzewidywalność stanu klinicznego pacjenta w okresie badania (np. z powodu przebytej operacji lub ostrego udaru).
    12. Procedury medyczne zaplanowane lub potencjalnie spodziewane w okresie pomiędzy wykonaniem badania angio-TK i badania angio-RM z gadobutrolem tj.:
    a. Procedura, mogąca zmieniać interpretację angio-RM lub angio-TK lub
    b. Procedura interwencyjna lub chirurgiczna obejmująca naczynia nadaortalne.
    E.5 End points
    E.5.1Primary end point(s)
    The following co-primary efficacy endpoints are based on the proportion of assessable vascular segments, and the sensitivity and specificity of clinically significant disease:
    - Superiority in the proportion of assessable segments with gadobutrol enhanced MRA compared to non-contrast MRA
    - Non-inferior detection of clinically significant disease based on sensitivity [70 to 99% stenosis] on a segmental basis
    - Non-inferior exclusion of clinically significant disease based on specificity [70 to 99% stenosis] on a segmental basis
    - The two minimum gadobutrol performance criteria (both sensitivity and specificity should exceed 50%)
    Ocena pięciu równorzędnych punktów końcowych oparta jest na proporcji możliwych do oceny odcinków naczyń krwionośnych, a także czułości i swoistości klinicznie istotnych zwężeń:
    • przewaga w proporcji możliwych do oceny odcinków naczyń krwionośnych w badaniu angio-RM z zastosowaniem gadobutrolu w porównaniu z badaniem angio-RM bez kontrastu
    • co najmniej taka sama skuteczność w zakresie rozpoznawania klinicznie istotnej choroby na podstawie czułości [zwężenie 70-99%] w poszczególnych odcinkach
    • co najmniej taka sama skuteczność w zakresie wykluczania klinicznie istotnej choroby na podstawie swoistości [zwężenie 70-99%] w poszczególnych odcinkach
    • dwa kryteria minimalnej skuteczności gadobutrolu (zarówno czułość, jak i swoistość powinny przekraczać 50%)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to two weeks
    E.5.2Secondary end point(s)
    The following secondary efficacy variables will be summarized:
    - Minimum diameter of the segment
    - Location and length of stenotic segments with ≥ 70% stenosis
    - Secondary radiologic indicators for diagnosis of clinically significant disease
    - Artifacts by type (segmental)
    - Diagnostic confidence (segmental)
    - Additional imaging studies recommended (example: CTA, CE MRA, Ultrasound, Nuclear Medicine)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to two weeks
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Australia
    Austria
    China
    Czech Republic
    France
    Germany
    Italy
    Korea, Republic of
    Poland
    Sweden
    Switzerland
    Turkey
    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
    For each participating EU country, the end of the study (according to the EU Clinical Trial Directive) will be reached when the last visit of the last subject for all centers in the respective country has occurred.
    As for this study, the primary outcome will be collected after last patient (or subject) last visit (LPLV), the end of the study as a whole will be the date when the clean data base is available.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-05-23. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If the subject is not capable of providing a signature, a verbal
    statement of consent can also be given in the presence of an impartial
    witness.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 265
    F.4.2.2In the whole clinical trial 398
    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)
    Not applicable for this diagnostic study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Not Applicable
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-28
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