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    Summary
    EudraCT Number:2009-010739-42
    Sponsor's Protocol Code Number:H6D-MC-LVID
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-26
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-010739-42
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia.
    A.3.2Name or abbreviated title of the trial where available
    LVID
    A.4.1Sponsor's protocol code numberH6D-MC-LVID
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 Cialis
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    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.3.4Pharmaceutical 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 INNtadalafil
    D.3.9.1CAS number 171596-29-5
    D.3.9.2Current sponsor code450190
    D.3.9.3Other descriptive nameTADALAFIL
    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 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.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 Yes
    D.2.1.1.1Trade name Omnic MR
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Modified-release capsule, hard
    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 INNTAMSULOSIN HYDROCHLORIDE
    D.3.9.1CAS number 106463176
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Benign Prostatic Hyperplasia (BPH)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10004446
    E.1.2Term Benign prostatic hyperplasia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of tadalafil 5 mg once daily for 12 weeks compared with placebo in improving the IPSS in men with signs and symptoms of BPH, also referred to as BPH-LUTS (lower urinary tract symptoms).
    E.2.2Secondary objectives of the trial
    To evaluate the:
    -efficacy of tamsulosin 0.4 mg daily compared with placebo in improving IPSS in men with BPH-LUTS.
    -efficacy of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo for in the treatment of men with BPH-LUTS.
    -efficacy of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo after 1 week and 4 weeks of treatment in men with BPH-LUTS as assessed by the modified IPSS (mIPSS).
    -efficacy of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo of treatment in men with BPH-LUTS and ED as assessed by the IIEF-EF Domain.
    -effect of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo in the treatment of men with BPH-LUTS as assessed by uroflowmetry measurements.
    -safety of tadalafil 5 mg daily and tamsulosin 0.4 mg daily in the treatment of men with BPH-LUTS.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sample Banking Addendum, H6D-MC-LVID(2), 22 April 2009.
    The collected samples are banked for research to identify the genes and/or gene products and/or biochemical markers associated with diseases and/or response to clinical trial medication or other medication taken during the trial. For example, in Study H6D-MC-LVID, the relationship among naturally occurring genetic variants in candidate genes, inflammatory serum markers such as C-reactive protein, and immunomodulation through a phosphodiesterase (PDE) inhibitor such as tadalafil may be investigated.
    E.3Principal inclusion criteria
    -Present with BPH (also referred to as BPH-LUTS) based on the disease diagnostic criteria at Visit 1.
    -Men 45 years of age or older at Visit 1.
    -Provide signed informed consent at Visit 1.
    -Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments, including alpha blockers, 5-alpha reductase inhibitors (5-ARIs), antimuscarinics, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at any time during the study.
    -Have not taken the following treatments within the indicated duration:
    [a] Finasteride therapy for at least 3 months prior to Visit 2.
    [b] Dutasteride therapy for at least 6 months prior to Visit 2.
    [c] Other BPH therapy (including herbal preparations) for at least
    4 weeks prior to Visit 2.
    [d] OAB therapy for at least 4 weeks prior to Visit 2.
    [e] ED therapy for at least 4 weeks prior to Visit 2.
    [f] Other experimental or off-label BPH therapy, such as injectable therapies with a protracted effect, for at least 1/2 year prior to Visit 2.
    -Have LUTS with a Total IPSS >=13 at Visit 2.
    -Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of >=4 to =<15 mL/second (from a prevoid total bladder volume [assessed by ultrasound] of >=150 to=<550 mL and a minimum voided volume of 125 mL) at Visit 2.
    -Demonstrate compliance with study drug administration requirements during the placebo lead-in period by administering >=70% of prescribed doses, confirmed by documentation that the subject returned <=30% of prescribed doses at Visit 3.
    E.4Principal exclusion criteria
    -PSA >10.0 ng/mL at Visit 1.
    -PSA >=4.0 to <=10.0 ng/mL at Visit 1 if prostate malignancy has not been ruled out to the satisfaction of an urologist.
    -Bladder PVR >=300 mL by ultrasound determination at Visit 1.
    -History of any of the following pelvic conditions:
    [a] Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection.
    [b] Pelvic radiotherapy.
    [c] Any pelvic surgical procedure of the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
    [d] Lower urinary tract malignancy or trauma.
    -Lower urinary tract instrumentation within 30 days of Visit 1.
    -History of urinary retention or lower urinary tract stones within 6 months of Visit 1.
    -History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
    -Clinical evidence of any of the following bladder conditions:
    [a] Mullerian duct cysts.
    [b] Atonic, decompensated, or hypocontractile bladder.
    [c] Detrusor-sphincter dyssynergia.
    [d] Intravesical obstruction.
    [e] Interstitial cystitis.
    -Clinical evidence of any of the following urinary tract conditions at Visit 1:
    [a] Urinary tract infection.
    [b] Urinary tract inflammation.
    [c] Current antibiotic therapy for urinary tract infection.
    [d] Clinically significant microscopic hematuria as determined by a urologist.
    -Clinical evidence of prostate cancer.
    -Current neurologic disease or condition associated with neurogenic bladder.
    -History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 mL/minute at Visit 1 as calculated by the central laboratory using the Cockroft-Gault Formula.
    -Clinical evidence of severe hepatic impairment at Visit 1.
    -History of any of the following cardiac conditions:
    [a] Angina requiring treatment with long-acting nitrates.
    [b] Angina requiring treatment with short-acting nitrates within 90 days of Visit 1.
    [c] Unstable angina within 90 days of Visit 1.
    [d] Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention.
    -History of any of the following coronary conditions within 90 days of Visit 1:
    [a] Myocardial infarction.
    [b] Coronary artery bypass graft surgery.
    [c] Percutaneous coronary intervention.
    -Any evidence of heart disease (New York Heart Association [NYHA] >=Class III within 6 months of Visit 1.
    -Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at Visit 1, or malignant hypertension.
    -Scheduled or planned surgery during the course of the study.
    -Scheduled or planned cataract surgery during the course of the study due to risk of intraoperative floppy iris syndrome (IFIS).
    -History of significant central nervous system injuries within 6 months of Visit 1.
    -History of drug, alcohol, or substance abuse within 6 months of Visit 1.
    -Any condition that would interfere with subject ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results.
    -Current treatment with nitrates, androgens, antiandrogens, estrogens, luteinizing
    hormone-releasing hormone agonists/antagonists, or anabolic steroids.
    -Current systemic treatment with any of the following:
    [a] Potent cytochrome P450 3A4 (CYP3A4) inhibitors, such as ketoconazole or ritonavir.
    [b] Potent CYP3A4 inducer, such as rifampicin.
    -Glycosylated hemoglobin (HbA1c) >9% at Visit 1.
    -Known or suspected hypersensitivity to tadalafil, tamsulosin or any study drug components.
    -History of symptomatic orthostatic hypotension, recurrent episodes of dizziness, vertigo, loss of consciousness, or syncope.
    -Are investigator site personnel directly affiliated with this study and/or their immediate families.
    -Are Lilly employees.
    -Previously completed or withdrawn from this study or any other study investigating tadalafil.
    -Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Subjects who have been screen failures in previous studies may be eligible.
    -History of loss of vision in 1 eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase type 5 (PDE5) inhibitor exposure.
    E.5 End points
    E.5.1Primary end point(s)
    Change in IPSS from baseline after 12 weeks.
    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 No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    See protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 370
    F.4.2.2In the whole clinical trial 453
    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)
    Not differentent from the expected normal treatment
    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 Decision2009-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-27
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