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    Summary
    EudraCT Number:2006-005145-11
    Sponsor's Protocol Code Number:BAY 38-9456 / 12392
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-21
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-005145-11
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled, parallel group study of vardenafil 10 mg twice daily to assess the effect on urodynamics in patients with Overactive Bladder (detrusor overactivity).
    A.4.1Sponsor's protocol code numberBAY 38-9456 / 12392
    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 SponsorBayer Healthcare 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 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 Yes
    D.2.1.1.1Trade name LEVITRA
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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.3.1Product namevardenafil HCL
    D.3.2Product code BAY 38-9456
    D.3.4Pharmaceutical form Film-coated 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 INNvardenafil
    D.3.9.1CAS number 224785-91-5
    D.3.9.2Current sponsor codeBay 38-9456
    D.3.9.3Other descriptive nameVARDENAFIL HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.8Extractive medicinal product No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Overactive bladder (detrusor overactivity)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the therapeutic effect of vardenafil on Overactive Bladder by means of urodynamic measurements (filling cystometry and pressure flow investigations).
    In addition, a micturition diary will be used.
    E.2.2Secondary objectives of the trial
    In addition to other variables derived from the urodynamic measurements and the micturition diary, a Quality of Life-questionnaire will be used. Population pharmacokinetics will be performed by correlating the treatment effect as determined through urodynamics with the plasma levels of vardenafil.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female patients aged > 18 years. Women must either be aged > 55 years being menopausal since at least 12 months, or must use an adequate birth control method (Note: as adequate method of birth control hormonal contraception, sterilization, spiral/IUD or sexual abstinence is recommended. Furthermore, double-barrier methods consisting of two of the following measures may be considered at the discretion of the investigator: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
    •Diagnosis of Overactive Bladder (OAB), with and without urge incontinence, for at least six months prior to Visit 1
    •At least one out of the three criteria below (to be assessed at Visit 2):
    oEntire bladder capacity (= maximum cystometric bladder capacity) < 300 mL.
    OR
    oIn accordance with ICS-guidelines: Detrusor overactivity as defined as spontaneous involuntary detrusor contraction during filling phase
    OR
    oDetrusor contraction during filling phase leading to involuntarily initiated micturition before a normal bladder capacity is reached.
    •Symptoms of OAB are to be assessed during the unmedicated run-in by a 7-day micturition diary (in-between Visits 1 and 2).
    oEach patient must show on average over all days documented:
    at least 8 micturitions per day and
    at least 1 urgency episode per day
    oEach patient must document a minimum of 3 consecutive days out of 7 days.
    •Patients capable of understanding the given information and having signed and dated written Patient Informed Consent Form after full discussion of the research nature of the treatment and its risks and benefits
    •Patients able to swallow the study medication in accordance with the protocol
    E.4Principal exclusion criteria
    Concomitant Medication
    •Drugs known to affect urinary bladder function (e.g. anticholinergics, antispasmodics, serotonin-noradrenalin-reuptake-inhibitors) 21 days prior to Visit 2 and during study
    •Solifenacin 28 days prior to Visit 2 and during study
    •Botulinum toxin, capsaicin or resiniferatoxin in the last 6 months prior to Visit 2 and during study
    •Cholinergic agonists and cholinesterase inhibitors, e.g. bethanecol, donepezil, rivastigmine
    •Nitrates or nitric oxide donors
    •PDE5 inhibitors within 7 days prior to Visit 1
    •Alpha-blockers
    •potent inhibitors of cytochrome P450 3A4: HIV protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents itraconazole and ketoconazole (topical forms allowed) or erythromycin or clarithromycin.
    •Acenocumarol or heparin.
    •Drugs known to prolong the QT interval, eg Class IA (eg quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmics
    •Androgens

    Previous or Current Medical Conditions - General
    •Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study
    •Loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION)
    •Hereditary degenerative retinal disorders such as retinitis pigmentosa
    •Any severe cardiovascular condition including unstable angina pectoris and severe myocardial insufficiency defined as stages III or IV according to NYHA-classification
    •History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
    •Congenital QT prolongation
    •Left ventricular outflow obstruction, e.g .due to Aortic valve disorder
    •Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate ≥ 100 bpm).
    •Resting hypotension (resting systolic blood pressure of < 90 mm Hg) or hypertension (resting systolic blood pressure > 170 mm Hg or resting diastolic blood pressure > 110 mm Hg).
    •Symptomatic postural hypotension within 6 months of Visit 1
    •History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C.
    •Significant active peptic ulceration
    •Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
    •In men: Clinically significant chronic haematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma and leukemia
    •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
    •Bleeding disorder

    Previous or Current Medical Conditions – Urinary Tract
    •Bladder fibrosis (low compliance and detrusor hyporeflexia/hypocontractility), detrusor-sphincter-dyssynergia (DSD), detrusor hyporeflexia/areflexia and bradykinesia/tremor of the external urethral sphincter
    •Males with post-void residual (PVR) urinary volume >150 mL at Baseline
    •Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator
    •History of secondary vesico-uretheral reflux
    •Chronic persistent local pathology that in the opinion of the investigator may lead to urinary symptoms, such as one of the genito-urinary pain syndromes, interstitial cystitis
    •Urolithiasis
    •Unexplained macro- and micro-hematuria, as determined by the investigator
    •Any urogenital surgery (including thermotherapy, ultrasound or laser therapy of the prostate, prostatectomy, hysterectomy, incontinence surgery) within 12 months prior to Visit 1
    •Bladder or prostate biopsy 30 days prior to Visit 1
    •Instrumentation of the lower urinary tract (including cystoscopy, urodynamics) within 14 days prior to Visit 1
    •Any history of pelvic radiation therapy
    •Indwelling catheter
    •Any history of carcinoma of the urogenital tract

    Abnormal Lab Values
    •ALT or AST > 3 x upper normal limit
    •Serum Creatinine > 3.0 mg/dl
    •Serum creatinine clearance (calculated) < 30.0 ml/min

    Other Exclusions
    •Pregnant or breast-feeding women; women of childbearing potential not using adequate birth control methods.
    •Participation in a bladder-training program or any electro stimulation therapy within the 2 weeks prior to Visit 1 or at any time during study
    •Receipt of any investigational drug (including placebo) within 30 days prior to Visit 1
    •Known hypersensitivity to vardenafil, BAY 38-9456 (also known as SB-782528) or any component of the investigational medication
    •Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule of study procedures
    •Subjects who are unwilling or unable to independently complete the micturition diary or questionnaires.
    •Subjects who are illiterate or unable to understand the micturition diary or questionnaires.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in bladder volume at first detrusor contraction, demonstrated on urodynamic measurements (filling cystometry and pressure flow investigations) at Week 6 (in absolute values). Co-primary target variable will be the change in the number of daily micturitions as reported in the patient diaries.
    Because of the rather demanding and cumbersome urodynamic examinations which have to be conducted at baseline and end of study recruitment may be difficult. As outlined in Chapter 6.2 sample size adjustments in terms of increased screening numbers are defined. If actual patient enrollment and dropout rates endanger the pre-planned study objectives because of poor recruitment the sequence of the primary efficacy variables will be changed. Under these conditions the primary efficacy variable will be the number of diary-documented micturitions and the volume at first detrusor contraction will be analyzed in a second step provided the micturition data show a significant superiority in favour of vardenafil.
    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 Yes
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    E.8.9.2In all countries concerned by the trial days15
    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 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 state75
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 612
    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 Decision2007-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-13
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    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
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