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    Summary
    EudraCT Number:2009-013552-72
    Sponsor's Protocol Code Number:P05664
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-07-02
    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 ConcernedFinland - Fimea
    A.2EudraCT number2009-013552-72
    A.3Full title of the trial
    A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)
    A.3.2Name or abbreviated title of the trial where available
    PARADYSE - Monotherapy
    A.4.1Sponsor's protocol code numberP05664
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01155479
    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 SponsorSchering-Plough Research Institute, a division of Schering Corporation
    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 supportSchering-Plough Research Institute, a division of Schering Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSchering-Plough Research Institute, a division of Schering Corporation
    B.5.2Functional name of contact pointKenneth Wolski, MD
    B.5.3 Address:
    B.5.3.1Street AddressUG 4C-18, 351 Sumneytown Pike, PO Box 1000
    B.5.3.2Town/ cityNorth Wales, PA
    B.5.3.3Post code19454-2505
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 267 305-3104
    B.5.5Fax number001 267 305-6640
    B.5.6E-mailkenneth.wolski@merck.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 namePreladenant
    D.3.2Product code SCH 420814
    D.3.4Pharmaceutical form 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 INNPreladenant
    D.3.9.1CAS number 377727-87-2
    D.3.9.2Current sponsor codeSCH 420814
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Azilect
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck (Schweiz) AG
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameAzilect
    D.3.4Pharmaceutical form Capsule, hard
    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 INNRasagiline mesylate
    D.3.9.1CAS number 161735-79-1
    D.3.9.3Other descriptive nameRASAGILINE MESYLATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Azilect
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAzilect
    D.3.4Pharmaceutical form Capsule, hard
    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 INNRasagiline mesylate
    D.3.9.1CAS number 161735-79-1
    D.3.9.3Other descriptive nameRASAGILINE MESYLATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboCoated 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 placeboCapsule, hard
    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
    Parkinson's disease
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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 objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early Parkinson's disease as measured by the sum of UPDRS Parts 2 and 3 scores. The primary safety objective of this trial is to evaluate the safety and tolerability of preladenant compared to placebo in subjects with early PD.
    E.2.2Secondary objectives of the trial
    The Key Secondary Objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early PD as measured by the proportion of Responders and by the the UPDRS Part 2 score.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects with a diagnosis of idiopathic PD for less than 5 years based on the United Kingdom Parkinson’s Disease Society Brain Bank Criteria (see Appendix 1) and the inclusion/exclusion criteria for this protocol.
    a. Subject should have bradykinesia and at least one of the following symptoms:
    i. Muscular rigidity
    ii. Resting tremor (4 to 6 Hz; Please note that for the purposes of this study, a diagnosis based solely on bradykinesia and postural instability is insufficient for diagnosis of idiopathic Parkinson's Disease, and subjects diagnosed in this manner cannot be enrolled in the study)
    b. If resting tremor is not present at screening, the rigidity and/or bradykinesia must be asymmetric.
    • Subject who is receiving amantadine and/or anticholinergics must have been on a stable regimen of treatment for at least the 5 weeks before Screening.
    • Each subject must have a UPDRS Part 3 score of >= 10.
    • Each subject's Hoehn and Yahr Stage must be <= 3.
    • Each subject must be willing and able to provide written informed consent for the trial. For a subject who is unable to provide independent consent, a legal representative may provide written informed consent. Subjects who are unwilling to provide written informed consent for exploratory pharmacogenetic testing may be included in the trial; however, exploratory pharmacogenetic samples must not be obtained.
    • Each subject must be 30 to 85 years of age. A subject may be of either gender and any race/ethnicity.
    • Each subject must have results of Screening clinical laboratory tests (hematology, blood chemistries, and urinalysis) drawn within 5 weeks (which can be extended by no more than 7 days, if the Sponsor's approval is obtained for the extension) prior to Randomization, clinically acceptable to the investigator, and not within the parameters specified for exclusion (below).
    • All subjects that are sexually active or plan to be sexually active agree to use a highly effective method of birth control while the subject is in the study and for 2 weeks after the last dose of study drug. A male subject must also not donate sperm during the trial and within 2 weeks after the last dose of study drug. Complete details regarding contraceptive requirements are specified in protocol Section 7.7.2.7.
    E.4Principal exclusion criteria
    Subjects must not have/be:
    • A form of drug induced or atypical parkinsonism, cognitive impairment (MoCA score<22), bipolar disorder, schizophrenia or other psychotic disorder.
    • A history of repeated strokes; with stepwise progression of Parkinsonian features; repeated head injury; definitive encephalitis; oculogyric crises; neuroleptic treatment at onset of symptoms; more than one first degree relative affected; sustained remission; strictly unilateral features after 3 years; supranuclear gaze palsy; cerebellar signs; early severe autonomic involvement; severe symptomatic autonomic involvement unrelated to medications; early severe dementia with disturbances of memory, language, and; praxis; Babinski sign with clear, clinically significant pyramidal tract involvement; negative response to large doses of L-dopa (if malabsorption excluded) or failure to respond to an adequate previous treatment with dopaminergic therapy; MPTP or known neurotoxin exposure; hallucinations unrelated to medications; surgery for PD.
    • Treated with L-dopa or dopamine agonists for 30 days or more. A subject who has been treated with L-dopa or dopamine agonists for <30 days at any time will be allowed to enrol. Subjects who are still taking dopaminergic medication at Screening or who stopped taking dopaminergic medication within 30 days of Randomization must still wash out from dopaminergic medication for a total of 30 days prior Randomization. Motor scores (UPDRS Pt3) should be evaluated at wash out Day 15, at an unscheduled Visit during the mandatory 30 day washout period for those subjects who stop taking their dopaminergic medications at Screening.
    • At imminent risk of self-harm or to others (in the investigator’s opinion based on CSSRS).
    • A systolic BP >=150mm Hg OR diastolic BP >=95mm Hg at Screening and at a BP recheck prior Randomization. Measures to control/adjust BP can be taken to meet the BP entry criterion up to Randomization (Day 1), but if the subject's BP is not within range on Day 1 then s/he cannot enrol. Repeated BP measurements intended to obtain acceptable BP entry criteria are not allowed, ie if the subject’s BP is not within the range as per BP exclusion criterion on Day 1 then s/he cannot be randomized. If BP is elevated at the Screening Visit, initiation or alteration of the dose of antihypertensive medicine can be done to obtain 2 BP measurements meeting this criterion at consecutive separate visits (scheduled or unscheduled) between the Screening Visit and the Randomization Visit (which is 5 weeks and may be extended by no more than 7days if the Sponsor's approval is obtained for the extension).
    • An untreated major depressive disorder meeting Diagnostic and Statistical Manual of Mental Disorders IV Text Revision criteria or BDI II score ≥19. A subject is eligible to enrol if successfully treated with stable doses of allowed antidepressant medications for at least 5 weeks immediately before Screening.
    • Any clinically significant cardiovascular event/procedure for 6 months prior Randomization, including but not limited to, myocardial infarction, prolonged QTc interval (a subject must not have a QTcF result >500msec), angioplasty, unstable angina or heart failure (staged NYHA Class III or IV).
    • An ALT or AST >=3 x ULN or total bilirubin (T-BIL) >=1.5 x ULN. Should an LFT be abnormal (ALT/AST >ULN but <3 x ULN, T-BIL >ULN but <1.5 x ULN) at Screening, the investigator should attempt to characterize at entry the reason(s) for elevation(s), eg, alcohol abuse , metabolic syndrome with fatty liver, etc. No repeat testing is allowed. Subjects with suspected Gilbert's Syndrome who have isolated T-BILI ≥1.5 x ULN may enter the study upon genetic confirmation (UGT1A1 assessment).
    • Active serologically confirmed hepatic dysfunction (defined as viral infection [Hepatitis B, C, or E; EBV; CMV) or a history of diagnosis of drug or alcohol-induced hepatic toxicity or frank hepatitis. If a subject has abnormal ALT or AST at Screening (>1.5 x ULN), the subject must have serology testing to rule out active viral hepatitis. A subject with history of serologically confirmed EBV or CMV may enrol in the trial as long as his/her viral infection was not associated with hepatitis in the past and his/her ALT or AST are normal at Screening. Types of serology assays to be performed are specified in the table of Laboratory Tests.
    • A history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical/prostate cancer with a normal PSA post resection.
    • Received any treatment listed more recently than the indicated period before Randomization. Note: Subjects who have been treated with L-dopa or dopamine agonists for <30 days may enrol provided they washout for 30 days prior Randomization.
    • A female subject must not be breast-feeding or considering breast-feeding or be pregnant or intending to become pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Week 26 (End of Part 1 treatment) in the sum of the UPDRS Parts 2 and 3 scores.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2,4,8,16,20,26,
    E.5.2Secondary end point(s)
    The Key Secondary Efficacy Endpoints are:
    • The proportion of Responders, where a Responder is defined as a subject with at least a 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment).
    • The change from Baseline in the UPDRS Part 2 score (Activities of Daily Living [ADL]) at Week 26.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2,4,8,16,20,26,
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 trial5
    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 EEA65
    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
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    Finland
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Mexico
    Netherlands
    Peru
    Poland
    Portugal
    Russian Federation
    Spain
    Sweden
    Turkey
    United Kingdom
    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
    The overall trial ends when the last remaining subject has ended participation in the trial, by completing the trial, being discontinued from the trial, or being lost to follow-up. A subject is considered to have fulfilled participation when he/she has completed the last protocol-specified contact (eg, visits or telephone contacts).
    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 months7
    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 months7
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 1000
    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)
    No treatment with the IMP beyond the final scheduled visit will be allowed under the current protocol
    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 Decision2010-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-07-16
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