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   43854   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:2010-023586-22
    Sponsor's Protocol Code Number:BAY38-9456/12912
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-023586-22
    A.3Full title of the trial
    Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vision loss diagnosed as a Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
    A.3.2Name or abbreviated title of the trial where available
    Bayer NAION Study
    A.4.1Sponsor's protocol code numberBAY38-9456/12912
    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 SponsorBayer AG
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930300139003
    B.5.6E-mailclinical-trials-contact@bayer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    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.2.5The 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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVARDENAFIL
    D.3.9.1CAS number 224785-90-4
    D.3.9.4EV Substance CodeSUB20047
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSILDENAFIL
    D.3.9.1CAS number 139755-83-2
    D.3.9.4EV Substance CodeSUB10517MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTADALAFIL
    D.3.9.1CAS number 171596-29-5
    D.3.9.4EV Substance CodeSUB12602MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAVANAFIL
    D.3.9.1CAS number 330784-47-9
    D.3.9.4EV Substance CodeSUB34916
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
    E.1.1.1Medical condition in easily understood language
    Vision loss diagnosed as a Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the use of PDE5 inhibitors (vardenafil, sildenafil, tadalafil or avanafil) increases the risk for the development of NAION.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be enrolled in the study, subjects must meet all of the following criteria:
    1. NAION onset within 45 days before entry to the study defined as including all of the following: Note: The time point of onset was changed in amendment 2.
    a) Visual field defect consistent with optic neuropathy
    b) Relative Afferent Pupillary Defect (RAPD) Subjects without RAPD may be included in the study if: 1) optic neuropathy was present in the non-study eye, preventing an RAPD in the study eye, or 2) an RAPD could not be measured because the subject had a non-study prosthetic eye or postsurgical pupils. Note: The modification of this inclusion criterion is described under amendment 2.
    c) Optic disc edema. Subjects without optic disc edema may be included in the study if optic disc edema was documented by another qualified physician after the onset of NAION and before entry into the study. Note: The modification of this inclusion criterion is described under amendment 2.
    2. NAION onset definable by the subject within a 2 calendar day window. (If the subject specifies an exact day of onset, the risk period will include that day and the preceding day.)
    3. Men who have taken at least 1 dose of PDE5 inhibitor(s) at any time in the 1 year prior to enrollment in the study.
    4. Age 40 years or older
    5. Ability to complete a phone interview and recall history adequately
    6. Documented, signed and dated written Informed Consent
    E.4Principal exclusion criteria
    1. History of multiple sclerosis (MS) or suggestive for MS (probable or possible MS) or optic neuritis (or any of the following symptoms or signs suggestive of these diagnoses)
    a) Pain on motion of the globe within 3 days of loss of vision
    b) Marked recovery of field loss and vision
    c) Marked delays on visual evoked potential
    2. Evidence of temporal arteritis, as indicated by any of the following findings:
    a) Positive temporal artery biopsy
    b) Jaw claudication or temporal tenderness
    c) Polymyalgia rheumatica
    d) High ESR (40 mm/h) platelets (>400 x 109 L), and/or CRP (>10 mg/dL). Subjects with an ESR above 40 mm/hr are allowed to be included if 1) the elevated sedimentation rate could be attributed to some other cause and/or 2) the subject had no other symptoms or indications of temporal arteritis or if temporal arteritis has been excluded by appropriate diagnostic methods. Note: The modification of this exclusion criterion is described under amendment 2.
    e) Large cup in fellow eye with a >50% cup to disc ratio
    3. History of vasculitis or collagen vascular disease (eg, systemic lupus erythematosus, polyarteritis nodosa), or any other inflammatory disease associated with arteritic anterior ischemic optic neuropathy (AION) or disc swelling
    4. Evidence of elevated intracranial pressure
    5. Daily dosing of PDE5 inhibitor for benign prostatic hyperplasia and/or pulmonary arterial hypertension.
    Opthalmological
    1. Any of the following orbital signs
    a) Proptosis or resistance to retropulsion which may be associated with Graves eye disease or Graves-related exophthalmos
    b) Arterialized conjunctival vessels
    c) Choroidal folds
    d) Orbital mass
    2. Ocular inflammation that may be associated with any of the following conditions:
    a) Iritis or vitritis
    b) Evidence of active sarcoidosis
    c) Evidence of active syphilis
    3. Acute glaucoma or intraocular pressure (IOP) 30 mmHg
    4. Retinal vein occlusion
    5. Previous history of NAION
    6. Retinal detachment
    7. Uveitis
    8. Lens opacities (which prevent an adequate examination)
    9. Use of any drugs known to affect the optic nerve or retina that cannot be excluded
    E.5 End points
    E.5.1Primary end point(s)
    The primary study variable is the relative risk (as measured by the HR) of NAION, contrasting PDE5 inhibitor exposure in the risk period with PDE5 inhibitor exposure during the control periods for each NAION case.
    Any additional safety information provided by the subject will be collected through the medical history taken at Visit 1 and any adverse events reported at Visit 2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be assessed at 2 visits, as summarized in the Study Flow Chart (Appendix 10.1). Visit 1 (Day 1) will include screening, confirmation of the diagnosis of NAION (with date and time of onset), enrollment, and collection of data on PDE5 inhibitor and other concomitant medication use. Visit 2 (Day 90) will be a follow-up visit to document the persistence of vision loss and confirm the diagnosis of NAION.
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    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
    prospective Case Cross-Over
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    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 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
    Australia
    Canada
    Germany
    Italy
    Mexico
    United States
    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
    last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 284
    F.1.3Elderly (>=65 years) Yes
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 284
    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 Decision2012-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-28
    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-Tue Apr 23 11:19:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA