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    Summary
    EudraCT Number:2009-015162-57
    Sponsor's Protocol Code Number:P06153
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-11
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-015162-57
    A.3Full title of the trial
    A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Active-Controlled Extension Study to P04938 and P07037 (P06153)
    A.4.1Sponsor's protocol code numberP06153
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01215227
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme corp.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme corp.
    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 number001267305-3104
    B.5.5Fax number001267305-6640
    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 MESILATE
    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 MESILATE
    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 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
    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
    To assess the long-term safety and tolerability of preladenant in subjects with moderate to severe PD.
    E.2.2Secondary objectives of the trial
    To characterize the long-term efficacy of preladenant in subjects with moderate to severe PD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects must have completed P04938 or P07037.
    • Each subject (or subject’s legal representative) must be willing and able to provide written informed consent for P06153. For a subject who is unable to provide independent consent, a legal representative may provide written informed consent.
    • Subjects must be able to adhere to dose and visit schedules.
    • Subjects must be taking levodopa (L-dopa).
    • Subjects may be taking any of the following additional adjunct PD medications: Amantadine, Anticholinergics, Dopa decarboxylase inhibitors, Dopamine agonists, Entacapone, L-dopa. Note: Subjects taking only L-dopa are permitted to enroll in this trial.
    • Each subject must have results of clinical laboratory tests (hematology, blood chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator as evidenced by the last available test results from the parent study (P04938 or P07037), and no results fall within the parameters for exclusion described below in the exclusion criterion for liver-related findings.
    • There has been no change in, or there has been no finding to warrant checking, serology status (for cytomegalovirus [CMV], Epstein-Barr virus [EBV], and Hepatitis B, C, and E).
    • Each subject must have results of a physical examination within normal limits, including blood pressure, within normal limits or clinically acceptable limits to the investigator, and not within the parameters for exclusion described below in the exclusion criterion for blood pressure.
    • 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 not donate sperm within 2 weeks after the last dose of study drug. Complete details regarding contraceptive requirements are specified in protocol Section 7.7.1.7.
    E.4Principal exclusion criteria
    • A subject must not have discontinued from P04938 or P07037 for any reason
    • A subject must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence)
    • A subject must not have poorly controlled diabetes( eg, HbA1c >8.5) or significantly abnormal renal function (eg, creatinine >2.0 mg/dL) in the opinion of the investigator
    • As a continuation of the liver-related withdrawal criteria from the parent studies (P04938 and P07037), any subject with elevated values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (T-BIL), as evidenced by the most recent chemistry panel results in the parent study, meeting any one of the following criteria:
    ALT or AST >8 x ULN
    ALT or AST >5 x ULN for more than 2 weeks
    ALT or AST >3 x ULN and T-BIL >2 x ULN or international normalized ratio [INR] >1.5 that is not due to anti-coagulation at the same visit
    ALT or AST >3 x ULN with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%)
    • As a continuation of the blood pressure (BP) withdrawal criteria from the parent studies (P04938 and P07037), any subject meeting the following criteria for the second of two consecutive visits separated by 7 days (ie, the subject met one of the BP criteria once already, 7 days before the P06153 Screening visit):
    Systolic BP ≥180 mm Hg or diastolic BP ≥105 mm Hg, or
    An elevation from Baseline BP in the parent study (P04938 or P07037) of systolic BP ≥40 mm Hg or diastolic BP ≥20 mm Hg
    • A subject must not have 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 cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection
    • A subject must not have an average daily consumption of more than three 4-ounce glasses (118 mL) of wine or the equivalent
    • Prohibited Concomitant Medications: A subject should not take or start taking any treatment listed below. A subject must not have received any treatment listed in the table below more recently than the indicated period before Day 1 of P06153. Tolcapone; Irreversible MAO inhibitors, eg, rasagiline, selegiline, Zydis selegiline; Reversible MAOB or MAOA inhibitor; Centrally acting dopamine antagonist (including metoclopramide, sulpiride, tiapride, etc.); alpha-methyldopa; Methylphenidate; Reserpine; Amphetamines; Flunarizine; Cinnarizine; Diphenhydramine used to treat parkinsonism; Theophylline; Meperidine, tramadol, methadone, propoxyphene, cocaine, or local anesthesia containing sympathomimetic vasoconstrictors; Dextromethorphan; Mirtazapine (a tetracyclic antidepressant), and cyclobenzaprine (a tricyclic muscle relaxant); Sympathomimetic amines including cold products, nasal and oral decongestants, and weight-reducing preparations that contain vasoconstrictors (eg, ephedrine, pseudoephedrine, phenylephrine, and phenylpropanolamine); St. John’s wort tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and selective serotonin reuptake inhibitors with the following exceptions: citalopram ≤20 mg/day, escitalopram ≤20 mg/day, paroxetine ≤30 mg/day, amitriptyline or nortriptyline ≤50 mg/day, trazodone or sertraline ≤100 mg/day; High tyramine-containing aged cheeses (eg, Stilton); Other potentially hepatotoxic drugs (including amiodarone, azathioprine, felbamate, imatinib, isoniazid, isotretinoin, leflunomide, methotrexate, nevirapine, pioglitazone, rosiglitazone, pyrazinamide, valproic acid, and voriconazole); Potent CYP3A4 inhibitors (eg, ritonavir, nelfinavir, indinavir); macrolide antibiotics (eg, erythromycin, clarithromycin, troleandomycin, telithromycin, [azithromycin is allowed]); and systemically administered antifungal agents (eg, ketoconazole, itraconazole); CYP3A4 inducers (eg, phenytoin, phenobarbital, barbiturates, systemic glucocorticoids); Atypical and typical neuroleptics (including depot formulations) except low dose quetiapine fumarate and clozapine
    • A subject must not have allergy/sensitivity to the investigational products or their excipients
    • A female subject must not be breast-feeding or considering breast-feeding
    • A female subject must not be pregnant or intending to become pregnant
    • A subject must not have any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial
    • A subject must not be a member of or a family member of the personnel of the investigational or sponsor staff directly involved with this trial
    E.5 End points
    E.5.1Primary end point(s)
    The Safety Endpoints are related to the Primary Trial Objective. Efficacy Endpoints will include change from Baseline in each of the following: MoCA score; EQ-5D score; PDQ-39 score; BDI-II score; Apathy Scale score;
    Diary data which include the following efficacy endpoints:
    Mean hours per day spent in the “off” state;
    Mean hours per day spent in the “on” state;
    Mean hours per day spent in the “on” state without troublesome dyskinesias;
    Mean hours per day spent in the “on” state with troublesome dyskinesias;
    Proportion of “on” time with no dyskinesias;
    Proportion of “on” time without troublesome dyskinesias;
    Proportion of “on” time with troublesome dyskinesias;
    Mean total sleep time.
    Total UPDRS score in the “on” state.
    UPDRS score for Parts 1, 2, and 3 combined.
    UPDRS score for Parts 2 and 3 combined.
    UPDRS subscale scores for Parts 1, 2, 3, and 4.
    Tremor domain of the UPDRS Part 3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 2, 4, 8, 16, 24, 32, and 40
    E.5.2Secondary end point(s)
    Efficacy Endpoints will include change from Baseline in each of the following:
    • MoCA score
    • EQ-5D score
    • PDQ-39 score
    • BDI-II score
    • Apathy Scale score
    • Diary data which include the following efficacy endpoints:
    - Mean hours per day spent in the "off" state;
    - Mean hours per day spent in the "on" state;
    - Mean hours per day spent in the "on" state without troublesome dyskinesias;
    - Mean hours per day spent in the "on" state with troublesome dyskinesias;
    - Proportion of "on" time with no dyskinesias;
    - Proportion of "on" time without troublesome dyskinesias;
    - Proportion of "on" time with troublesome dyskinesias;
    - Mean total sleep time.
    • Total UPDRS score in the "on" state.
    - UPDRS score for Parts 1, 2, and 3 combined.
    - UPDRS score for Parts 2 and 3 combined.
    - UPDRS subscale scores for Parts 1, 2, 3, and 4.
    - Tremor domain of the UPDRS Part 3.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 2, 4, 8, 16, 24, 32, and 40
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    Croatia
    Czech Republic
    Finland
    France
    Germany
    India
    Israel
    Italy
    Latvia
    Lithuania
    Mexico
    Netherlands
    Peru
    Poland
    Portugal
    Russian Federation
    Serbia
    South Africa
    Spain
    Sweden
    Turkey
    Ukraine
    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
    Last Subject Last Visit
    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 months6
    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 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.1.1.1In 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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 750
    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 Decision2011-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-16
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