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    Summary
    EudraCT Number:2004-004862-33
    Sponsor's Protocol Code Number:BCBe/04/Neb-Gla/081
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-02-06
    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 number2004-004862-33
    A.3Full title of the trial
    INFLUENCE OF NEBIVOLOL ON OCULAR PERFUSION IN PATIENTS WITH ARTERIAL HYPERTENSION AND GLAUCOMA
    A mono-center, active-substance controlled, randomized, double-blind,
    prospective phase IV parallel-group trial comparing Nebivolol with Bisoprolol
    A.3.2Name or abbreviated title of the trial where available
    Influence of nebivolol on ocular perfusion in patients with arterial hypertension and glaucoma
    A.4.1Sponsor's protocol code numberBCBe/04/Neb-Gla/081
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBerlin-Chemie Menarini
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameNebivolol
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNebivolol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameConcor
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBisoprololhemifumarat
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Arterial hypertension and glaucoma
    MedDRA Classification
    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 influence of Nebivolol as compared to Bisoprolol on the peak systolic and end-diastolic blood flow velocity in the short and the long posterior ciliary artery. It is assumed that Nebivolol may influence the ocular perfusion positively by peripheral vasodilatation induced by the stimulation of the NO-system.
    E.2.2Secondary objectives of the trial
    To assess the influence of Nebivolol as compared to Bisoprolol
    - on the peak systolic and end-diastolic blood flow velocity in the central retinal artery
    - on the peak systolic and end-diastolic blood flow velocity in the ophthalmic artery
    - on the resistive index (RI) in the:
    a.short posterior ciliary artery
    b.long posterior ciliary artery
    c.central retinal artery
    d.ophthalmic artery
    - on the pulsatility index (PI) in the
    a.short posterior ciliary artery
    b.long posterior ciliary artery
    c.central retinal artery
    d.ophthalmic artery
    - on capillary blood flow in the retina
    - on the diameter of retinal vessels
    - on the Time average maximum velocity (TAMx)
    - on the Time average minimum velocity (TAMm)
    - on the blood pressure
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years or older
    2. Stable glaucoma associated with a pathological excavation of the
    optical nerve head and visual field defects
    3. No other previous eye surgery than cataract surgery and/or cyclophotocoagulation, deep sclerectomy, trabeculectomy or related surgical procedures which were performed > 4 weeks before study entry
    4. Refractive error between – 6 and + 6 dpt
    5. Arterial hypertension adequately and stable (≥ 3 months) treated
    in combination- or mono therapy with a beta-blocker except for current treatment with Nebivolol, Bisoprolol or Carvidilol (blood pressure prior to switch of the antihypertensive medication to the trial medication: < 140 mmHg SBP and < 90 mmHg DBP)
    E.4Principal exclusion criteria
    1. Secondary hypertension
    2. Untreated heart failure or uncompensated heart failure
    3. Sick-sinus-syndrome including heart blocks (SA node) and/or AV block 2nd and 3rd degree and/or significant arrhythmia and/or bradycardia < 50 bpm (in resting condition prior to treatment)
    4. Cardiogenic Shock
    5. Bradycardia (< 50 bpm prior to treatment)
    6. Hypotension with systolic blood pressure < 90 mmHg
    7. Known hypersensitivity to Nebivolol or Bisoprolol or any of the ingredients of the trial medication or any known hypersensitivity to ß-blockers
    8. Bronchial hyperreactivity, bronchial asthma, or history of bronchial spasm
    9. Patients with known SGPT (ALAT) and SGOT (ASAT) levels exceeding three times the upper limit of the investigator's normal range, known serum bilirubin > 1.75 mg/dl (> 30 µ mol/l) or clinical evidence of severe hepatic disease or hepatic failure
    10. Untreated pheochromocytoma
    11. Metabolic acidosis
    12. Peripheral arterial occlusive disease > IIa (PAOD) or Raynaud’s syndrome
    13. History of myocardial infarction within the last 3 months prior to study inclusion
    14. Unstable angina pectoris
    15. Prior or active malignancy in the previous 5 years except adequately treated basal cell/ squamous cell carcinoma of the skin or carcinoma in situ of the cervix
    16. Previous treatment within 30 days prior to the beginning of the study or concomitant treatment with substances which may decrease the efficacy of the test substance(s) or may lead to drug interactions, for example: MAO inhibitors, systemic sympathomi- metics, intravenous application of calcium-antagonists of verapamil- or diltiazem-type or other antiarrhythmic agents except for intensive care, aldosterone analogues
    17. Anticipated dose change of statins if patient is treated with statins already or anticipated need for statins if patient is currently not treated with statins
    18. Previous topical and/or systemic glaucoma medication not stable for > 14 days prior to visit 2
    19. Anticipated dose change of topical glaucoma medication (including dorzolamide) or anticipated dose change of magnesium-containing preparations
    20. Patients with psychiatric diseases
    21. Patients with a history of alcohol and/or drug abuse
    22. Patients who are currently participating in another clinical study or who have received an investigational drug within 30 days prior to entering the study
    23. Patients who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period
    24. Women of childbearing potential without adequate contraception; medically acceptable methods are contraceptive implant (contraceptive injection, intrauterine device (IUD), or oral contraceptives taken for at least 3 months, which the patient agrees to continue using during the study.
    25. Patients who are pregnant or lactate (Pregnancy should be ruled out by serum pregnancy test)
    26. Intake of coffee and/or smoking < 2 hours before Laser Doppler Flowmetry
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable:
    - Peak systolic blood flow velocity (PSV) in the short posterior ciliary artery
    - PSV in the long posterior ciliary artery
    - End diastolic blood flow velocity (EDV) in the short posterior ciliary artery
    - EDV in the long posterior ciliary artery

    Secondary efficacy variable(s):
    - Changes of the peak systolic and end systolic blood flow velocity in the central retinal artery after 6 weeks of treatment
    - Changes of the peak systolic and end systolic blood flow velocity in the ophthalmic artery after 6 weeks of treatment
    - Changes of the resistive index (RI) after 6 weeks of treatment in
    - short posterior ciliary artery
    - long posterior ciliary artery
    - central retinal artery
    - ophthalmic artery
    - Changes of the pulsatility index (PI) after 6 weeks of treatment in
    - short posterior ciliary artery
    - long posterior ciliary artery
    - central retinal artery
    - ophthalmic artery
    - Time average maximum velocity (TAMx)
    - Time average minimum velocity (TAMm)
    - Retinal capillary blood flow, velocity and volume in the para-papillary region and the fovea
    - Vessel diameter of the retinal arteries
    - Changes of Blood pressure after 6 weeks of treatment
    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 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 Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 patient 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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    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 2007-02-06. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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 Decision2006-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-12-31
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