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    Summary
    EudraCT Number:2005-001678-28
    Sponsor's Protocol Code Number:BAY 38-9456 / IMPACT 11875
    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:2005-08-02
    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 number2005-001678-28
    A.3Full title of the trial
    A randomized, explorative, double-blind, double-dummy, multi-center, parallel group study to assess sustainable efficacy of once daily vardenafil (10 mg) for 12 and 24 weeks versus vardenafil PRN in men with mild or mild to moderate erectile dysfunction
    A.3.2Name or abbreviated title of the trial where available
    RESTORE
    A.4.1Sponsor's protocol code numberBAY 38-9456 / IMPACT 11875
    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
    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
    Erectile Dysfunction
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10061461
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to explore the prophylactic (prophylaxis of deterioration) or curative efficacy and safety of long-term (12 and 24 weeks) daily administration of vardenafil therapy (administration at night) versus vardenafil PRN on erectile dysfunction in men with mild or mild to moderate, predominantly organic ED.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess descriptively whether this estimated treatment effect depends upon the duration of daily dosing of the PDE-5 inhibitor. Furthermore, it shall be assessed descriptively whether or not the immediate and the possible sustainable effect on ED corresponds with an effect on patients' satisfaction by using a validated ED-specific questionnaire (TSS).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Males 18-64 years of age
    Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
    History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
    Stable, heterosexual relationship for more than six months
    Documented, signed and dated written Informed Consent
    E.4Principal exclusion criteria
    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
    Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease) in the opinion of the Investigator would significantly impair sexual performance
    Primary hypoactive sexual desire
    Spinal cord injury
    History of glaucoma
    History of surgical prostatectomy (transurethral intervention not excluded)
    Hereditary degenerative retinal disorders such as retinitis pigmentosa
    History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C
    Known 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
    Any underlying cardiovascular condition including e.g. unstable angina pectoris or ventricular failure NYHA stages III or IV, that would preclude sexual activity; symptomatic angina pectoris
    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)
    Resting hypotension (a resting systolic blood pressure of <90 mm Hg or diastolic blood pressure of < 50 mmHg)
    Insufficiently controlled hypertension: In patients known to be hypertensive, hypertension has to be sufficiently controlled with antihypertensives in the opinion of the physician treating the hypertension. In addtion, resting blood pressure at visit 1 (singular measurement not appropriate to judge on control of hypertension) must not be >170 mmHg (systolic) or > 110 mmHg (diastolic) irrespective of a patient having been classified as hypertensive or not.
    Symptomatic postural hypotension within six months of Visit 1
    History of malignancy within the past 5 years (other than squamous or basal cell skin cancer)
    Life expectancy <3 years
    Clinical diagnosis of significant untreated sleep apnea or working night shifts (e.g. 23:00h to 7:00 h).
    Diabetes mellitus type 1

    B) Concomitant Medication
    Nitrates or nitric oxide donors
    Oral or injectable or transdermally applied androgens
    Anti-androgens
    Anti-coagulants, with the exception of anti-platelet agents
    Any of the following potent inhibitors of cytochrome P- 450 3A4:
    potent inhibitors: HIV protease inhibitors (indinavir, nelfinavir, ritonavir, atazanavir, lopinavir, amprenavir, saquinavir), makrolid/-ketolid antibiotics (clarithromycin, erythromycin, telithromycin), anti-mycotic agents (itraconazole, ketoconazole [topical forms are allowed]), anti-depressants (nefazodon)
    less potent inhibitors: quinupristin/-dalfupristin, fluconazol, amiodaron, diltiazem, fluvoxamin, verapamil, valproinic acid, fluoxetin; grapefruit juice
    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
    Alpha blockers during randomised treatment and wash-out.

    C) Abnormal Laboratory Values
    Serum total testosterone level >25% below the lower limit of normal (according to the range of the testing laboratory).
    HbA1c greater or equal 9 (“excessively uncontrolled diabetes”)
    Serum creatinine > 3.0 mg/dL
    Creatinine clearance < 30 ml/min
    Elevation of AST and/or ALT >3X the upper limit of normal

    D) Other Exclusions
    Known hypersensitivity to vardenafil, Bay 38-9456 (also known as SB-782528) or any component of the investigational medication
    Subjects unwilling to cease use of vacuum devices, intracavernosal invection, Viagra®, or other therapy for ED.
    Patients illiterate or are unable to understand the questionnaires or subject diary
    Patients unwilling or unable to complete the subject diary or questionnaires
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable will be the Erectile Dysfunction change score from baseline of the International Index of Erectile Function (IIEF-EF) as observed in week 24-28 (treatment ’24 weeks nightly’), and week 12-16 (treatment ’12 weeks nightly’), and week 24-28 (treatment ’24 weeks PRN’).
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different dosage regiment: daily dosing versus dosing if needed, i.e. before sexual activity
    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 months11
    E.8.9.1In the Member State concerned days
    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 state267
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 267
    F.4.2.2In the whole clinical trial 267
    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 Decision2005-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-03-20
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