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    Summary
    EudraCT Number:2010-024244-15
    Sponsor's Protocol Code Number:RDG-10-251
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-024244-15
    A.3Full title of the trial
    Patient Preference Comparison of AZARGA versus COSOPT, in Patients with Open-Angle Glaucoma or Ocular Hypertension
    Valutazione della preferenza della somministrazione di Azarga nei confronti di Cosopt, in Pazienti affetti da Glaucoma ad angolo aperto o ipertensione oculare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ND
    ND
    A.4.1Sponsor's protocol code numberRDG-10-251
    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 SponsorALCON RESEARCH, LTD.
    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 supportALCON RESEARCH LTD
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALCON FRANCE
    B.5.2Functional name of contact pointSTUDY MANAGER - MEDICAL AFFAIRS
    B.5.3 Address:
    B.5.3.1Street Address4, RUE HENRI SAINTE-CLAIRE DEVILLE
    B.5.3.2Town/ cityRUEIL-MALMAISON CEDEX
    B.5.3.3Post code92563
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 47 10 1335
    B.5.5Fax number+33 1 47 10 4841
    B.5.6E-mailCAMILLE.GIRAULT@ALCONLABS.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 AZARGA*COLL 1FL5ML 10MG+5MG/ML
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBRINZOLAMIDE
    D.3.9.1CAS number 138890-62-7
    D.3.9.4EV Substance CodeSUB05892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIMOLOL MALEATE
    D.3.9.1CAS number 26921-17-5
    D.3.9.4EV Substance CodeSUB04875MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 COSOPT*COLL 2%+0,5% 1FL 5ML OC
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDORZOLAMIDE HYDROCHLORIDE
    D.3.9.1CAS number 130693-82-2
    D.3.9.4EV Substance CodeSUB01820MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.26
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIMOLOL MALEATE
    D.3.9.1CAS number 26921-17-5
    D.3.9.4EV Substance CodeSUB04875MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.83
    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
    Patients with Open-Angle Glaucoma or Ocular Hypertension
    Pazienti con una diagnosi di glaucoma ad angolo aperto o ipertensione oculare
    E.1.1.1Medical condition in easily understood language
    ND
    ND
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.2System Organ Class 10015919 - Eye 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 patient preference of AZARGA compared to COSOPT after one week instillation of each study medication is administered to both eyes, in patients with open-angle glaucoma or ocular hypertension.
    Valutare la preferenza di AZARGA rispetto a COSOPT dopo che per una settimana entrambi i trattamenti in studio vengono somministrati in entrambi gli occhi a pazienti con glaucoma ad angolo aperto o ipertensione oculare
    E.2.2Secondary objectives of the trial
    To assess differences in the ocular discomfort of the study medications.
    Valutare le differenze tra i due farmaci rispetto al non-confort oculare.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must be at least 18 years of age. 2. Must have a clinical diagnosis of ocular hypertension, open-angle with or without pseudoexfoliation or pigment dispersion glaucoma in both eyes. 3. Must be on a stable regimen IOP lowering medication within 30 days of Screening Visit. 4. Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. 5. Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye). 6. Must be willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the Screening Visit and for the entire course of the study. 7. Must be able to follow instructions and be willing and able to attend all study visits. 8. Local Ethics Committees reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating subject, as well as signed and dated by the individual (Principal Investigator or Sub-investigator) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
    1. una età ≥ di 18 anni. 2. diagnosi di ipertensione oculare, glaucoma ad angolo aperto o pigmentario con o senza pseudo esfoliazioni in entrambi gli occhi. 3. essere in un regime stabile di farmaco per la riduzione della PIO entro 30 giorni dalla visita di Screening. 4. avere una PIO considerata stabile ( secondo il parere dello Sperimentatore) in entrambi gli occhi, in modo da assicurare una stabilità clinica della vista e del nervo ottico durante tutto il periodo dello studio. 5. avere una PIO compresa tra 19-35 mmHg in almeno un occhio(che sarà l’occhio dello studio). 6. essere consenzienti ad interrompere l’uso di altri farmaci oculari (prescrivibili e non) prima di ricevere la dose di screening e per tutta la durata dello studio 7. essere in grado di seguire le istruzioni e essere disponibili a partecipare a tutte le visite dello studio. 8. I Comitati Etici locali abbiano esaminato ed approvato(per l’uso in questo studio) il modulo di consenso informato che deve essere letto, firmato e datato dai pazienti partecipanti e dalla persona che ottiene il consenso(Sperimentatore o Co-sperimentatore). Il consenso informato deve essere ottenuto prima della Visita di Screening e prima dell’inizio delle procedure dello studio.
    E.4Principal exclusion criteria
    1. Known history of hypersensitivity to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator. 2. Best corrected visual acuity that is worse than 20/80 Snellen in either eye. 3. Any abnormality preventing reliable applanation tonometry in either eye. 4. Corneal dystrophies. 5. Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye. 6. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed. 7. Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit. 8. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment. 9. Progressive retinal or optic nerve disease from any cause. 10. History of ocular herpes simplex. 11. History of hyperchloremic acidosis. 12. Severe allergic rhinitis or bronchial hypersensitivity that would preclude the safe use of a topical beta-blocker. 13. Severe renal impairment 14. Use of any topical carbonic anhydrase inhibitor (single or fixed combination) within a year of the Screening Visit. 15. Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. 16. Sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock that would preclude the safe administration of a topical beta-blocker. 17. Any clinically significant, serious, or severe medical or psychiatric condition. 18. Women of childbearing potential not using reliable means of birth control. A reliable effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. 19. Women who are pregnant or lactating 20. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject. 21. Participation in any other investigational study within 30 days prior to the Screening Visit.
    1. Storia di pregressa allergia, ipersensibilità a qualsiasi componente della preparazione utilizzata nello studio o che è considerata clinicamente significativa secondo il parere dello Sperimentatore Principale . 2. Acuità visiva corretta in entrambi gli occhi minore di 20/80 Snellen. 3. Qualsiasi anomalia che impedisca un’affidabile misurazione della pressione oculare in entrambi gli occhi. 4. Distrofie Corneali. 5. Qualsiasi opacità o non cooperatività del Soggetto che limita l’esame adeguato del fondo oculare o della camera anteriore di entrambi gli occhi . 6. Concomitanti congiuntivite infettive e non, cheratiti o uveite in entrambi gli occhi. Blefarite o iniezione congiuntivale non clinicamente significative sono consentite. 7. Chirurgia intraoculare convenzionale o laser in entrambi gli occhi da meno di tre mesi prima della visita di screening. 8. Rischio di peggioramento del campo visivo o peggioramento della acutezza visiva a seguito della partecipazione allo studio, o a giudizio dello Sperimentatore. 9. Malattia progressive della retina o del nervo ottico dovuto a qualsiasi causa. 10. Precedenti episodi di Herpex Simplex oculari. 11. Storia di acidosi ipercloremica. 12. Rinite allergica grave o ipersensibilità bronchiale che potrebbero precludere l’utilizzo sicuro di beta-bloccante topico. 13. Grave insufficienza renale. 14. L’uso di qualsiasi inibitore topico dell’anidrasi carbonica(singolo o in combinazione) entro un anno dalla visita di screening. 15. Asma bronchiale, storia di asma bronchiale, o grave malattia polmonare ostruttiva cronica che potrebbero precludere la gestione sicura di un beta-bloccante topico. 16. Bradicardia sinusale, blocco atrioventricolare di secondo terzo grado, insufficienza cardiaca conclamata, o shock cardiogeno che potrebbe precludere la gestione sicura di un beta bloccante topico. 17. Qualsiasi condizione medica o psichiatrica seria o clinicamente significativa. 18. Donne in età gestionale che non usano un mezzo affidabile di controllo della nascita. Un metodo efficace di controllo delle nascite è un metodo che garantisce un tasso di fallimento basso(cioè meno di 1% all’anno), quando utilizzato in modo coerente e corretto; come protesi , iniettabili, contraccettivi orali combinati, alcuni IUDs, l’astinenza sessuale o la vasectomia del partner. Per i Soggetti che utilizzano un metodo contraccettivo ormonale, le informazioni relative al prodotto utilizzato e il suo potenziale effetto contraccettivo dovrebbero essere valutati. 19. Donne in gravidanza o in allattamento. 20. Qualsiasi condizione che a parere dello Sperimentatore Principale potrebbe interferire con la partecipazione ottimale del paziente nello studio, o che potrebbe costituire un rischio particolare per il paziente. 21. La partecipazione a qualsiasi altro studio clinico nei 30 giorni precedenti la Visita di screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is the preferred treatment indicated on the Subject Preference Questionnaire after patients have been dosed with both study medication on Day 15.
    End point primario è la preferenza al trattamento indicato nel Questionario di Preferenza del Soggetto dopo che il paziente è stato trattato con entrambi i farmaci al giorno 15.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15
    Giorno 15
    E.5.2Secondary end point(s)
    The secondary efficacy parameter is assessed by results from the Ocular Discomfort Scale after patients have been dosed with each study medication on Day 7 and 15.
    End point secondario è valutato attraverso i risultati della scala di non fastidio oculare dopo che i pazienti sono stati trattati con entrambi i farmaci al giorno 7 e giorno 15
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7 and day 15
    Giorno 7 e giorno 15
    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 No
    E.6.4Safety No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    subjects will be masked to study medic received (single masked) but to min investigators bias
    Single Masked- double blind (to avoid bias of PIs)
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm 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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 112
    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)
    ND
    ND
    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 Decision2011-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-13
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