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    Summary
    EudraCT Number:2005-002796-32
    Sponsor's Protocol Code Number:BAY 38-9456 / 11863
    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:2005-10-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-002796-32
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-center, parallel group study to assess the efficacy of vardenafil in the treatment of symtomatic Benign Prostatic Hyperplasia
    A.4.1Sponsor's protocol code numberBAY 38-9456 / 11863
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Levitra 10 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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.3.1Product nameLevitra 10 mg Filmtabletten
    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-HCL
    D.3.9.1CAS number 224785-91-5
    D.3.9.2Current sponsor codeBAY 38-9456 / SB-782528
    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 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
    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
    Benigne Prostatic Hyperplasia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10004446
    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 efficacy, tolerability and safety of vardenafil (10 mg BID) versus placebo in the two month treatment of men with symptomatic BPH.
    E.2.2Secondary objectives of the trial
    Secondary variables of efficacy are
    - the Post-void residual urine volume (PVR),
    - the Quality-of-life questionnaire 9 (QoL-9) and
    - the erectile function domain of the International Index of Erectile Function (IIEF-EF).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    At SCREENING
    - Males 45 to (including) 64 years of age
    - Lower urinary tract symptoms (LUTS) for >= 6 months
    - Documented, signed and dated written Informed Consent

    At RANDOMIZATION
    - IPSS total score >= 12
    E.4Principal exclusion criteria
    At SCREENING

    A) Previous or Current Medical Conditions

    - 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
    - Spinal cord injury
    - Hereditary degenerative retinal disorders such as retinitis pigmentosa
    - History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C
    - Severe chronic or acute liver disease, including history of moderate (Child-Pugh B)
    or severe (Child-Pugh C) hepatic impairment
    - Clinically significant chronic hematological disease which may lead to priapism
    such as sickle cell anemia, multiple myeloma or leukemia
    - Clinically significant bleeding disorder
    - Significant active peptic ulceration
    - Prostatitis (chronic or current)
    - Known vesical tumors (benign or malign)
    - History of prostate cancer
    - Clinically significant stricture of bladder or urethra
    - History of or current urinary retention
    - History of clinically significant pelvic trauma or surgery
    - Known stones or concrements in the urinary tract
    - Neurological diseases or symptoms that may interfere with voiding
    - Any underlying cardiovascular condition including unstable angina pectoris
    that would preclude sexual activity
    - History of myocardial infarction, stroke, or life-threatening arrhythmia
    within the prior 6 months
    - Uncontrolled atrial fibrillation/flutter at screening
    (ventricular response rate > 100 bpm)
    - Current macro-hematuria
    - Resting hypotension (a resting systolic blood pressure of <90 mm Hg)
    or hypertension (a resting systolic blood pressure >170 mm Hg
    or a resting diastolic blood pressure >110 mm Hg)
    - Symptomatic postural hypotension within 6 months of Visit 1
    - History of malignancy within the past 5 years (other than squamous or basal cell skin cancer)
    - Life expectancy <3 years
    - Previous episode of non arteritic ischemic optic neuropathy (NAION)

    B) Concomitant Medication

    - Nitrates or nitric oxide donors
    - Oral, injectable or trans-dermal androgens
    - Anti-androgens
    - Any of the following potent inhibitors of cytochrome P- 450 3A4:
    . HIV protease inhibitors such as ritonavir or indinavir;
    . anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed);
    . erythromycin
    - Any investigational drug (including placebo) within 30 days of Visit 1
    - Any treatment for ED other than study medication during the study,
    including oral medications, vacuum devices, constrictive devices, injections
    or urethral suppositories
    - Alpha1 adrenoceptor antagonists (alpha blockers) during entire course of the study
    - Previous or current use of inhibitors of 5-alpha-reductase
    (e.g. finasteride, dutasteride).

    C) Abnormal Laboratory Values

    - PSA >= 3 ng/ml
    - Creatinine Clearance < 30 mL/min
    - Elevation of AST and/or ALT >= 3 x the Upper Limit of Normal
    - Micro-hematuria (assessment by means of dipsticks)

    D) Other Exclusions

    - Known hypersensitivity to vardenafil, Bay 38-9456 (also known as SB-782528)
    or any component of the investigational medication
    - Illiterate or are unable to understand the questionnaires
    - Unwilling or unable to complete the questionnaires

    At RANDAMIZATION
    - All SCREENING Exclusion Criteria
    - Residual urine volume > 100 mL (sonographic assessment)
    - Micro- or macro-hematuria
    - If alpha-blockers were withdrawn at Visit 1 (Screening):
    significant (in the opinion of the investigator) deterioration of any BPH-related
    symptomatology during the run-in phase.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints of efficacy are
    - the International Prostate Symptoms Score (IPSS) and
    - the maximum urinary flow (Q max)
    which will be tested in a hierarchical order.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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
    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 days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    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 state280
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 280
    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 Decision2005-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-06-19
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