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    Summary
    EudraCT Number:2009-016800-22
    Sponsor's Protocol Code Number:I1A-MC-BPAE (b)
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-07-07
    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 ConcernedGreece - EOF
    A.2EudraCT number2009-016800-22
    A.3Full title of the trial
    A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 weeks in Men with Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH).
    A.3.2Name or abbreviated title of the trial where available
    BPAE
    A.4.1Sponsor's protocol code numberI1A-MC-BPAE (b)
    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 Limited
    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 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 nameLY500307
    D.3.2Product code LY500307
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeLY500307
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 nameLY500307
    D.3.2Product code LY500307
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeLY500307
    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: 3
    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 nameLY500307
    D.3.2Product code LY500307
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeLY500307
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    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 compare the effect of LY500307 once daily for 24 weeks versus placebo treatment in improving the IPSS in men with LUTS and prostatic enlargement secondary to BPH.
    E.2.2Secondary objectives of the trial
    - To compare the effect of 24 weeks of LY500307 versus placebo treatment on the TPV as measured by TRUS.
    - To evaluate the effect of 24 weeks of LY500307 versus placebo treatment on Qmax.
    - To evaluate the effect of 24 weeks of LY500307 versus placebo treatment on: BPH-related QoL assessed by IPSS-QoL Index; and IPSS storage, voiding, and nocturia subscores.
    - To evaluate the effect of 24 weeks of LY500307 versus placebo treatment on PSA.
    - To evaluate LY500307 PK and factors affecting LY500307 exposure in men with LUTS and prostatic enlargement secondary to BPH.
    - To evaluate the relationship between LY500307 exposure and clinical efficacy as well as safety measures.
    - To assess the safety of LY500307 once daily for 24 weeks in the treatment of men with LUTS and prostatic enlargement secondary to BPH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Only male patients are eligible to be included in the study and only if they meet all of the following criteria:
    [1] Present at Visit 1 with a history of BPH based on the diagnostic criteria (see Section 8.1.1).
    [2] Agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
    [3] Are at least 45 years of age at the time of screening (Visit 1).
    [4] Have an IPSS ≥13 at the placebo lead-in visit (Visit 2).
    [5] Have a TPV by TRUS ≥30 mL at the placebo lead-in visit (Visit 2).
    [6] Show signs of bladder outlet obstruction as defined by a peak urinary flow rate (Qmax) ≥4 and ≤15 mL/sec (from a prevoid total bladder volume [assessed by ultrasound or echography] of ≥150 to ≤ 550 mL and a minimum voided volume of 125 mL) at Visit 2.
    [7] Have a PSA ≥1.4 and ≤10 ng/mL at screening (Visit 1). If, at screening, the patient’s PSA is >4 ng/mL, prostate cancer must be excluded via a documented prostate biopsy within 12 months of Visit 1 or prior to the patient’s Visit 2.
    [7a] If the PSA criterion is not met at screening (Visit 1), the patient may undergo 1 retest if active new patient screening is ongoing.
    [8] Demonstrate a PVR ≤300 mL by ultrasound or echography at the placebo lead-in visit (Visit 2).
    [9] Have not received the following treatments within the specified time period (9a through 9f):
    [9a] Finasteride or dutasteride for at least 6 months prior to Visit 2.
    [9b] Any alpha-adrenergic antagonists for at least 4 weeks prior to Visit 2.
    [9c] Any other non-experimental BPH therapy (including an herbal preparation) for at least 4 weeks prior to Visit 2.
    [9d] Any other experimental or off-label BPH therapy such as injectable therapies with a protracted effect for at least 6 months prior to Visit 2.
    [9e] Any overactive bladder treatment for at least 4 weeks prior to Visit 2.
    [9f] Any ED treatment which may include oral PDE type 5 inhibitors or devices for at least 4 weeks prior to Visit 2.
    [10] Have a morning fasting TT concentration ≥300 ng/dL (≥3.0ng/mL, ≥10.40nmol/L) at screening (Visit 1).
    [10a] If the TT criterion is not met at screening (Visit 1), the patient may undergo 1 retest if active new patient screening is ongoing.
    [11] If currently taking statin treatment, must be stable on treatment as determined by the investigator for at least 2 months prior to Visit 2.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    General Exclusion Criteria
    [12] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    [13] Are Lilly employees.
    [14] Are currently enrolled in, or discontinued within the last 30 days (at Visit 1) from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    [15] Have completed or withdrawn from this study after exposure to study drug or have completed or withdrawn from any other study investigating LY500307 after exposure to study drug. Patients who previously screen failed from this study [based upon protocol version (a)] but who the investigator determines may now meet criteria will be allowed to rescreen for the study 1 time as long as the patient was not previously exposed to study drug (including placebo lead-in).
    [16] Are unable, unreliable, and/or unwilling to provide informed consent, make themselves available for the duration of the study, and refuse to comply with the procedures and study restrictions.
    Medical Condition Criteria
    [17] Have any history of BPH-related invasive procedures (for example, TURP, open prostatectomy, and minimally invasive procedures that include thermal-based therapies, transurethral microwave treatment, transurethral needle ablation, and stents).
    [18] Have active cardiovascular disease as evidenced by the following (18a through 18d):
    [18a] Recent MI, unstable angina, stroke or TIA within 6 months of Visit 2.
    [18b] Recent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of Visit 2.
    [18c] Recent history of positive stress tests without any written documentation of effective intervention within 6 months of Visit 2.
    [18d] Evidence of heart disease categorized as ≥Class III functional classification of NYHA (Attachment 10) within 6 months of Visit 2.
    [19] Have known or suspected history of prostate cancer, breast cancer, or other clinically significant neoplastic disease (other than squamous cell or basal cell carcinoma of skin).
    [20] Have a history of deep venous thrombosis or pulmonary embolism disease.
    [21] Have moderate to severe renal insufficiency (defined as an eGFR <50 mL/min/1.73m2 calculated from the MDRD formula [Huang et al. 2009]).
    [21a] If the eGFR criterion is not met at screening (Visit 1), the patient may undergo 1 retest of initial screening if new patient screening is ongoing.
    [22] Have a hemoglobin A1c (HbA1c) >9.0%.
    [23] Are on testosterone replacement therapy, or drugs that influence the hypothalamus-pituitary-gonadal axis, which may include any estrogen preparation, SERMs, GnRH agonists/antagonists, or androgen receptor antagonists (within 1 month prior to Visit 1); or are on long-acting formulations of testosterone replacement therapy, within 3 half-lifes prior to Visit 1. Patients on stable doses of thyroid replacement therapy will be allowed in this study.
    [24] Are on non-statin pharmacological agents for treatment of hyperlipidemia. Non-prescription strength fish oil use for prophylactic purposes is allowed.
    E.5 End points
    E.5.1Primary end point(s)
    The mean change in IPSS total score from baseline to endpoint.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Yes
    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
    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 years1
    E.8.9.1In the Member State concerned months7
    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 months11
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 575
    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)
    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 Decision2010-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-08-30
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