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    Summary
    EudraCT Number:2017-002495-20
    Sponsor's Protocol Code Number:000108
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-13
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002495-20
    A.3Full title of the trial
    A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix or Leuprolide
    A.4.1Sponsor's protocol code number000108
    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 SponsorFerring Pharmaceuticals A/S
    B.1.3.4CountryDenmark
    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 supportFerring Pharmaceuticals A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerring Pharmaceuticals A/S
    B.5.2Functional name of contact pointClinical Development Support
    B.5.3 Address:
    B.5.3.1Street AddressKay Fiskers Plads 11
    B.5.3.2Town/ cityCopenhagen S
    B.5.3.3Post codeDK-2300
    B.5.3.4CountryDenmark
    B.5.4Telephone number+1862-286-5200
    B.5.6E-mailDK0-Disclosure@ferring.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 FIRMAGON
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals A/S
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDegarelix
    D.3.9.1CAS number 934016-19-0
    D.3.9.3Other descriptive nameDEGARELIX ACETATE
    D.3.9.4EV Substance CodeSUB27749
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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 FIRMAGON
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals A/S
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDegarelix
    D.3.9.1CAS number 934016-19-0
    D.3.9.3Other descriptive nameDEGARELIX ACETATE
    D.3.9.4EV Substance CodeSUB27749
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Lupron Depot
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLupron Depot
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUPRORELIN ACETATE
    D.3.9.1CAS number 74381-53-6
    D.3.9.4EV Substance CodeSUB02900MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    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
    Advanced Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071119
    E.1.2Term Hormone-dependent prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 is to assess the effect of a gonadotropin-releasing hormone (GnRH) receptor antagonist (degarelix) on the risk of occurrence of major adverse cardiovascular events (MACEs) (a composite of death due to any cause, non-fatal myocardial infarction or non-fatal stroke) as compared to a GnRH receptor agonist (leuprolide) in patients with prostate cancer and concomitant cardiovascular disease (CVD)
    E.2.2Secondary objectives of the trial
    CV- and Death-Related Objectives:
    To assess the rate of specific MACEs (individual components of the composite MACE endpoint), i.e. myocardial infarction (fatal, non-fatal) or stroke (fatal, non-fatal), in patients randomized to degarelix versus leuprolide
    Prostate Cancer-Related Objectives:
    To monitor testosterone levels at Days 28, 168, and 336 in the degarelix and leuprolide treatment groups
    Health Economics and Patient Reported Outcome Objectives:
    To compare the effects of degarelix with leuprolide with regards to healthcare resource use
    Safety Objective:
    To evaluate and compare the overall safety and tolerability of degarelix with leuprolide
    Exploratory Objectives:
    To compare the effects of degarelix with leuprolide with regards to a second confirmed (adjudicated) occurrence of the composite MACE endpoint, in the subgroup of patients that survived the first CV event
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed informed consent obtained before any trial-related activity is performed.
    2.Histologically confirmed adenocarcinoma of the prostate.
    3.Clinical tumor staging (Tumor, Nodule and Metastasis [TNM]) available prior to treatment start; radiographic imaging (bone scan and/or CT scan and/or MRI) performed within 3 months prior to randomization. If no radiographic image is available at the time of screening, a bone scan should be performed.
    4.Investigator judgment to initiate continued androgen deprivation therapy (ADT) with an intended treatment duration of 12 months or longer including any of the following disease categories:
    A.Patients with metastatic prostate cancer at the time of diagnosis.
    B.Patients with prostate cancer who develop metastases after local therapy.
    C.Patients with prostate cancer with very high-risk, high-risk or intermediate-risk disease with features of unfavourable prognosis who are going to be treated with definitive radiation therapy in combination with at least 12 months of neoadjuvant/adjuvant ADT.
    D.Patients with biochemical recurrence after local therapy who have a PSA doubling time <12 months.
    E.Patients previously treated with definitive local therapy (without ADT combination) who due to risk features such as positive margins, seminal vesicle invasion, extracapsular extension, or detectable PSA, will be treated with salvage radiation therapy in combination with neoadjuvant/adjuvant ADT that is planned for 12 months or longer.
    F.Patients with locally advanced prostate cancer who are not candidates (who are unsuited) for definitive therapy with surgery or radiation and will be treated with primary ADT.
    5.Patients must be treatment-naïve with regard to ADT at time of randomization (with the exception of prior history of neoadjuvant/adjuvant ADT to definitive therapy for which the last administration, e.g., injection of a depot ADT formulation was at least 12 months prior to randomization).
    6.Patients must have a screening serum testosterone level above the lower limit of normal range, defined as >150 ng/dL (5.2 nmol/L), apart from those who had prior neoadjuvant/adjuvant ADT (>12 months prior to randomization) where non-castrate range (>50 ng/dL or ≥1.73 nmol/L) should be applied.
    7.Patients must have an Eastern Cooperative Oncology Group (ECOG) score of ≤2.
    8.Pre-existing CVD (confirmed diagnosis prior to randomization) with at least one of the following criteria documented with applicable medical source documents:
    A.Prior myocardial infarction ≥30 days before randomization.
    B.Prior revascularization procedure ≥30 days before randomization, specified as any of the following:
    Coronary artery stent placement or coronary artery balloon angioplasty
    Coronary artery bypass graft surgery
    Stent placement or balloon angioplasty to a carotid, iliac, femoral, or popliteal artery
    Carotid endarterectomy surgery
    Vascular bypass surgery of the iliac, femoral, or popliteal arteries
    C.Results from an angiogram or CT angiogram of the coronary, carotid, iliac, femoral, or popliteal arteries that documented at least one vascular stenosis ≥50% at any time point before randomization.
    D.Carotid ultrasound results that documented a vascular stenosis ≥50% at any time point before randomization.
    E.Ankle-brachial pressure index (ABPI) <0.9 at any time point before randomization.
    E.4Principal exclusion criteria
    1.Previous or current hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, ketoconazole, abiraterone and enzalutamide); except neoadjuvant/adjuvant ADT (in this case treatment has to be terminated at least 12 months prior to randomization).
    2.Hypersensitivity towards any component of the IMPs or excipients.
    3.Uncontrolled type 1 or type 2 diabetes mellitus (defined as hemoglobin A1c [HbA1c] >10%) at time of randomization.
    4.Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) at time of randomization.
    5.A history of congenital Long QT Syndrome or risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, concomitant medication known to cause QT prolongation).
    6.Myocardial infarction within 30 days prior to randomization.
    7.Stroke (hemorrhagic or ischemic) within 30 days prior to randomization.
    8.Coronary, carotid, or peripheral artery revascularization within 30 days prior to randomization.
    9.Planned or scheduled cardiac surgery or PCI procedure that is known at the time of randomization.
    10.Other clinically significant disorder (other than prostate cancer and CVD) including, but not limited to, renal, hematological, gastrointestinal, endocrine, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient’s health or the outcome of the trial as judged by the Investigator.
    11.Mental incapacity or language barrier precluding adequate understanding or co-operation.
    12.Treatment with an investigational drug within the last month prior to randomization or longer if considered to possibly influence the outcome of the current trial or planned or concurrent participation in a clinical trial for any investigational drug or device.
    E.5 End points
    E.5.1Primary end point(s)
    Time from randomization to the first confirmed (adjudicated) occurrence of the MACE composite endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For each patient randomized into the study, the endpoint is evaluated from the time of randomization until the patient either completes or discontinues from the trial, whichever occurs first.
    E.5.2Secondary end point(s)
    1.Time from randomization to occurrence of the individual components of the MACE composite endpoint, i.e. myocardial infarction (fatal, non-fatal) or stroke (fatal, non-fatal).
    2.Time from randomization to occurrence of unstable angina requiring hospitalization (fatal, non-fatal).
    3.Time from randomization to death due to any cause.
    4.Time from randomization to CV-related death.
    5. Testosterone levels.
    6. Time from randomization to PFS failure.
    7.Change from baseline in IPSS Total and QoL scores.
    8.Total number of CV-related hospitalization events over the duration of the trial.
    9.Total number of coronary artery by-pass grafting (CABG) or percutaneous coronary intervention (PCI) procedures over the duration of the trial.
    10.Total number of emergency room (ER) visit events over the duration of the trial.
    11.Change in utility, based on EQ-5D-5L.
    12.Change from baseline in DASI Global score.
    13.Change from baseline in CAQ Global score and score per domain.
    14.Incidence and intensity of adverse events
    15.Changes in vital signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4.For each patient(P) randomized into the study, the endpoint(EP) is evaluated from the time of randomiz until the (P) either completes or disc from the trial, whichever occurs first
    5.Days 28,168and336
    6.For each P rand into the study, the EP ev from the time of rand until the P either completes or disc from the trial, whichever occurs first
    7,8.Days 0,84,168,252,336 and/or end of treatment(EoT)
    9.For each P rand into the study, the EP is ev from the time of rand until the P either completes or disc from the trial, whichever occurs first
    10.For each P rand into the study, the EP is ev from the time of rand until the P either completes or disc from the trial, whichever occurs first
    11,13.Days 0,168 and 336 and/or EoT
    14,15.Days 0,28,56,84, 112,140,168,196,224,252,280,308,336

    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 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 Yes
    E.8.1.7.1Other trial design description
    assesor blind
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    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
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Slovakia
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 810
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 900
    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)
    NA as both test and comparator are Marketed Products
    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 Decision2018-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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