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    Summary
    EudraCT Number:2008-000536-40
    Sponsor's Protocol Code Number:BAY38-9456/12093
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-08
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-000536-40
    A.3Full title of the trial
    Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction (ED) - a fixed-dose, double-blind, raNdomized multi-center Trial - POTENT I
    A.3.2Name or abbreviated title of the trial where available
    POTENT I * including amendment 1 to Protocol
    A.4.1Sponsor's protocol code numberBAY38-9456/12093
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernone
    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, D-51368 Leverkusen, Germany
    B.1.3.4CountryNetherlands
    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 No
    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 ODT 10 mg
    D.3.2Product code BAY 38-9456
    D.3.4Pharmaceutical form Orodispersible tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 placeboOrodispersible 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
    Erectile Dysfunction (ED)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061461
    E.1.2Term Erectile dysfunction
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the efficacy and safety of vardenafil ODT 10 mg (PRN) after 12 weeks of treatment or LOCF with placebo in a general population of men with erectile dysfunction. In this study, 50% of the men on active treatment have to be 65 years-of-age or older.
    Primary efficacy variables are:
    - IIEF-EF Domain score at visit 4 (week 12) or LOCF
    - SEP 2 (success rates of penetration) and SEP 3 (maintenance of erection) at visit 4 (week 12) overall (co-primary variable)
    E.2.2Secondary objectives of the trial
    Secondary efficacy variables include:
    - Percentage of subjects achieving “back to normal” erectile function (IIEF-EF >= 26) at visit 4 (week 12) or LOCF;
    - All diary questions other than SEP 2 and 3 concerning erectile function administered over the entire treatment period;
    - Treatment Satisfaction Scale (TSS) to be administered at the randomization visit and the final visit (or at Premature Discontinuation).
    - A Global Assessment Question (GAQ) concerning the overall effect on erectile function to be administered at the final visit only.
    - Number of sexual attempts under medication till first successful attempts (SEP 3)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    24 Subjects will have PK- pharmacokinetic evaluations done at special selected sites.
    Details are in the protocol that also describes the main study, no additional documentation.
    E.3Principal inclusion criteria
    1) Males 18 years-of-age or older.
    2) Stable, heterosexual relationship for at least 6 months.
    3) A history of erectile dysfunction (ED) for at least 6 months, defined as “the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse” by the NIH Consensus Development Panel on Impotence.1
    4) The subject must make at least four attempts at sexual intercourse on four separate days during the untreated baseline period (according to the answer to the following question in the Subject Diary: “Was sexual activity initiated with the intention of intercourse?”) (to be fulfilled at visit 2).
    5) At least 50% of attempts at sexual intercourse during the untreated baseline period must be unsuccessful, according to the following questions from the Subject Diary (at least one question should be answered with a “No”): a)“Were you able to achieve at least some erection (some enlargement of the penis)?” b)“Were you able to insert your penis in your partner’s vagina?” c)”Did your erection last long enough for you to have successful intercourse?” (to be fulfilled at visit 2).
    6) Subjects highly motivated to obtain treatment for erectile dysfunction.
    7) Documented, dated, written informed consent.
    E.4Principal exclusion criteria
    1) Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report.1
    2) History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1 (= screening).
    3) Uncontrolled atrial fibrillation / flutter at screening (defined as ventricular response rate ≥ 100 bpm).
    4) Bleeding disorder.
    5) History of surgical prostatectomy because of prostate cancer, including nerve-sparing techniques. Clarification: Any surgical procedures for the treatment of benign prostate hypertrophy (BPH) are permitted, with the exception of cryosurgery, cryotherapy or cryoablation.
    6) Hereditary degenerative retinal disorders such as retinitis pigmentosa.
    7) History of loss of vision because of NAION, temporary or permanent loss of vision, including unilateral loss of vision.
    8) Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease) which, in the investigator’s opinion, would significantly impair sexual performance.
    9) Subjects who have been confirmed with phenylketonuria (PKU).
    10) Primary hypoactive sexual desire.
    11) Spinal cord injury.
    12) Severe chronic or acute liver disease, history of moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment.
    13) Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma, and leukemia.
    14) Active peptic ulceration.
    15) 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).
    16) History of syncope within the last 6 months prior to entry into the study.
    17) History of malignancy within the past 5 years (other than squamous or basal cell skin cancer).
    18) History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.
    19) Symptomatic postural hypotension within 6 months of Visit 1.
    20) 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.
    21) History of congenital QT prolongation.
    22) History of uni-or bilateral hearing loss
    4.2.2.2 Concomitant medication
    1) Subjects who are taking nitrates or nitric oxide donors.
    2) Subjects who are exposed to androgens irrespective of their mode of administration.
    3) Subjects who are taking anti-androgens. Clarification: 5alpha-reductase inhibitors, commonly not classified as anti-androgens, are permitted.
    4) Subjects who are taking alpha-blockers.
    5) Subjects who are taking the following potent inhibitors of cytochrome P450 3A4: HIV protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents itraconazole or ketoconazole (topical forms are allowed), and the macrolide antibiotics clarithromycin and erythromycin.
    6) Subjects who have received any investigational drug (including placebo) within 30 days of Visit 1.
    7) Use of any treatment for ED within 7 days of Visit 1 or during the study including oral medications, vacuum devices, constrictive devices, injections, urethral suppositories, gels, any over-the-counter or non-prescription medications, and products purchased via the internet.
    8) Subjects who are taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics.
    4.2.2.3 Abnormal laboratory values
    1) Subjects who have a total serum testosterone level of more than 25% below the lower limit of normal according to the range of the testing laboratory.
    2) Subjects with a serum creatinine clearance (calculated) < 30.0 mg/min.
    3) Elevation of AST and/or ALT > 3 times the upper limit of normal.
    4.2.2.4 Other exclusion criteria
    1) Subjects unwilling to cease use of any treatment for ED during the study, including oral medications, vacuum devices, constrictive devices, injections, urethral suppositories, gels, any over-the-counter or non-prescription medications, and products purchased via the internet.
    2) Subjects with known hypersensitivity to vardenafil, BAY 38-9456 (also known as SB-782528) or any component of the investigational medication.
    3) Subjects who are illiterate or unable to understand the questionnaires or the Subject Diary.
    4) Subjects who are unwilling or unable to complete the Subject Diary.
    5) Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    See objectives.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    fixed dose
    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.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    The end of the study is defined as the Last Patient Last Visit date. This is the date of the last follow-up telephone call after visit 4 (or visit 5 for PK subjects).
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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.1.3Elderly (>=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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 350
    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 the subject has ended his participation in the trial, he is treated according to local medical practice.
    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 Decision2008-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
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