Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-005166-22
    Sponsor's Protocol Code Number:M2018
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-07
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-005166-22
    A.3Full title of the trial
    Effect of acetazolamide on the incidence of high altitude pulmonary edema at 4559 m
    Effekt von Acetazolamid auf die Inzidenz des Höhenlungenödems in 4559 m Höhe
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of acetazolamide on the frequency of high altitude pulmonary edema at 4559 m
    Wirkung von Acetazolamid auf die Häufigkeit des Höhenlungenödems in 4559 m Höhe
    A.3.2Name or abbreviated title of the trial where available
    Acetazolamide and HAPE
    Acetazolamid und HLÖ
    A.4.1Sponsor's protocol code numberM2018
    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 SponsorUK für Anästhesiologie und allgemeine Intensivmedizin
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUK für Anästhesiologie und allgemeine Intensivmedizin
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUK für Anästhesiologie und allgemeine Intensivmedizin
    B.5.2Functional name of contact pointSekretariat
    B.5.3 Address:
    B.5.3.1Street AddressMüllner Hauptstraße 48
    B.5.3.2Town/ citySalzburg
    B.5.3.3Post code5020
    B.5.3.4CountryAustria
    B.5.4Telephone number0043057255 57794
    B.5.5Fax number0043057255 24199
    B.5.6E-mailma.berger@salk.at
    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 Acemit 250 mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holdermedphano Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNACETAZOLAMIDE SODIUM
    D.3.9.1CAS number 1424-27-7
    D.3.9.2Current sponsor codeM2018
    D.3.9.4EV Substance CodeSUB00251MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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
    Healthy volunteer trial at 4459m to investigate the effect of acetazolamide on the incidence of high altitude pulmonary edema.
    Studie an gesunden Freiwilligen auf 4559m um den Effekt von Acetazolamid auf die Inzidenz des Höhenlungenödems zu untersuchen.
    E.1.1.1Medical condition in easily understood language
    High altitude pulmonary edema is a non-cardiogenic pulmonary edema. Symptoms are inappropriate dyspnea during exercise, reduced exercise performance, mild fever, orthopnea, pink frothy sputum.
    Das Höhenlungenödem ist ein nicht-kardiales Ödem, das sich durch Atemnot, eine inadäquate Leistungsminderung, leichtes Fieber, Orthopnoe sowie teilweise blutig schaumigen Auswurf äußert.
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020045
    E.1.2Term High altitude illness
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does acetazolamide reduce the incidence of high altitude pulmoanry edema after rapid and active ascent to 4559 m?
    Reduziert Acetazolamid die Inzidenz des Höhenlungenödems nach schnellem Aufstieg auf 4559 m?
    E.2.2Secondary objectives of the trial
    1. Does acetazolamide reduce the height of pulmonary artery pressure after rapid, active ascent to 4559 m?
    2. Does acetazolamide reduce the incidence of acute mountain sickness after rapid, active ascent to 4559 m?
    1. Reduziert Acetazolamid die Höhe des Lungenarteriendruckes nach schnellem Aufstieg auf 4559 m?
    2. Reduziert Acetazolamid die Inzidenz der Akuten Bergkrankheit nach schnellem Aufstieg auf 4559 m?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-64 years
    - Previous history of high altitude pulmonary edema
    - Good physical condition
    - No relevant pathologies upon the pre-examination prior to the study
    - Written informed consent to participate in the study
    - Permanent residency below 1000 m
    - Males and females are included without prioritization
    - Previous experience in the use of crampons and ice axe
    - Alter: 18-64 Jahre
    - Höhenlungenödem in der Vorgeschichte
    - Guter Gesundheitszustand (geistig/körperlich)
    - Keine klinisch relevanten pathologischen Befunde bei der Voruntersuchung
    - Freiwillig unterzeichnete Einverständniserklärung nach vollständiger Information bezüglich der Studie
    - Ansässig / Hauptaufenthaltsort in einer Höhe unter 1000 m
    - Bezüglich der Geschlechterverteilung gibt es keine Vorgaben und werden Männer und Frauen gleichermaßen berücksichtigt
    - Erfahrung in der Benutzung von Steigeisen und Pickel
    E.4Principal exclusion criteria
    - Acute and chronic lung diseases
    - Conventional systolic blood pressure (average of two measurements) ≥150 mmHg and conventional diastolic blood pressure ≥95 mmHg in untreated or treated subjects
    - Cardiovascular diseases other than systemic arterial hypertension (coronary heart disease, pulmonary hypertension, heart failure, atrial fibrillation, peripheral artery disease)
    - Chronic headache / migraine
    - Diabetes mellitus
    - Smoking (>6 cigarettes/day) or equivalent nicotine substitutes
    - Alcohol (>30 g/d) or drug abuse
    - Obesity (Body Mass Index >30)
    - Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders, pregnancy, lactation)
    - Sojourn >2000 m within the last 4 weeks before the 1st study day
    - Drug intake within the last 2 moth before the 1st study day if the drug intake could affect the data quality (eg. corticosteroids) or the safety of the participants (eg. anti-coagulants)
    - Hypersensitivity to acetazolamide, sulfonamides, or any component of the formulation
    - Blood donation within the last 2 month before the 1st study da
    - Akute und chronische Lungenerkrankungen
    - Arterielle Hypertonie mit systolischen Blutdruckwerten >150 mmHg und diatolischen Blutdruckwerten >95 mmHg
    - Weitere kardiovaskuläre Erkrankungen (koronare Herzerkrankung, Herzinsuffizienz, Vorhofflimmern, periphere arterielle Verschlusskrankheit)
    - Chronischer Kopfschmerz / Migräne
    - Diabetes mellitus
    - Weitere Erkrankungen mit Relevanz für die Studie (z.B. Leber-, Nieren- und Schilddrüsenfunktionsstörung, Schwangerschaft, Stillzeit)
    - Nikotinkonsum (>6 Zigaretten/Tag), Nicorette
    - Alkoholabusus (>30 g/Tag), Drogenabusus
    - Adipositas (Body Mass Index >30)
    - Aufenthalt über 2000 m innerhalb der letzten 4 Wochen vor dem Untersuchungstermin
    - Medikamenteneinnahme innerhalb der letzten 2 Monate, wenn sie die Probandensicherheit oder die Datenqualität beeinflussen könnte
    - Allerie / Unverträglichkeit bzgl. Acetazolamid, Sulfonamiden oder weiteren Bestandteile des Studien-Medikaments
    - Blutspende innerhalb der letzten 2 Monate
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of high altitude pulmonary edema
    Inzidenz des Höhenlungenödems
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 72 hours at 4559 m
    Nach 72 Stunden auf 4559 m
    E.5.2Secondary end point(s)
    1. Height of pulmonary artery systolic pressure
    2. Incidence of acute mountain sickness
    1. Höhe des systolischen pulmonalarteriellen Druckes
    2. Inzidenz der Akuten Bergkrankheit
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 72 hours at 4559 m
    Nach 72 Stunden auf 4559 m
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days14
    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: 20
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-02-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    After termination of the trial, we will contact the subjects by phone to evaluate the general state of health and potential side-effects.
    Nach Abschluss der Studie werden die Probanden nochmals telefonisch kontaktiert bezüglich Allgemeinzustand und möglichen Nebenwirkungen.
    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 Decision2018-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-08
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 22:12:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA