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    Summary
    EudraCT Number:2013-003397-27
    Sponsor's Protocol Code Number:BDB-AS-301
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-24
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-003397-27
    A.3Full title of the trial
    A Randomized, Double Blind, Double Dummy, Placebo Controlled, Parallel Group, 12 Week Clinical Study to Assess the Efficacy and Safety Of 320 or 640 mcg/Day of Beclomethasone Dipropionate Delivered via Breath Actuated Inhaler (BAI) or Metered Dose Inhaler (MDI) in Adolescent and Adult Patients 12 Years of Age and Older with Persistent Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12 Week Study to the Effectivenes and Safety Of 2 doses of Beclomethasone Dipropionate using a Breath Actuated Inhaler (BAI) or Metered Dose Inhaler (MDI) in Adolescent and Adult Patients 12 Years of Age and Older with Persistent Asthma
    A.4.1Sponsor's protocol code numberBDB-AS-301
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTeva Branded Pharmaceutical Products R&D, Inc.
    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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointKirsty Moore
    B.5.3 Address:
    B.5.3.1Street AddressGranta Park
    B.5.3.2Town/ cityGreat Abington, Cambridge
    B.5.3.3Post codeCB21 6GQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441406331204
    B.5.5Fax number441223374101
    B.5.6E-mailKirsty.Moore@ppdi.com
    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 nameBeclomethasone Dipropionate Delivered via Breath Actuated Inhaler (BAI) - 80 mcg
    D.3.4Pharmaceutical form Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.3Other descriptive nameBECLOMETASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 nameBeclomethasone Dipropionate Delivered via Breath Actuated Inhaler (BAI) - 40 mcg
    D.3.4Pharmaceutical form Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.3Other descriptive nameBECLOMETASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 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 Qvar 50 Aerosol
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK 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 Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.3Other descriptive nameBECLOMETASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 4
    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 Qvar 100 Aerosol
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK 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 Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.3Other descriptive nameBECLOMETASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboInhalation vapour, solution
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation vapour, solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Persistent Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    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 evaluate the efficacy of beclomethasone dipropionate (320 or 640 mcg/day) administered via BAI and MDI with placebo treatment in patients with persistent asthma as assessed by the change from baseline in trough morning forced expiratory volume in 1 second (FEV1) over the 12 week treatment period.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of beclomethasone dipropionate treatment administered via BAI and MDI compared with placebo treatment in patients with persistent asthma as assessed by the change from baseline in weekly average of daily trough morning and evening peak expiratory flow (PEF), in the time to patient withdrawal due to meeting stopping criteria for worsening asthma, in change from baseline in rescue medication use, and the change from baseline in the weekly average of the total daily asthma symptom score during the 12 week treatment period

    To evaluate the safety and tolerability of beclomethasone dipropionate treatment as assessed by the occurrence of treatment emergent adverse events (TEAEs) and vital signs assessments throughout the study; physical examination findings and clinical laboratory evaluations at SV and the final treatment visit (TV4/TdV); and oropharyngeal examination findings at every visit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Severity of disease: The patient has persistent asthma, with an FEV1 40% 85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at the screening visit (SV).
    b. Current asthma therapy: The patient must be on a stable dose of an inhaled corticosteroid (ICS) of at least 440 mcg/day of fluticasone propionate or equivalent for a minimum of 4 weeks before SV, or any ICS/long acting β2 agonist (LABA) combination for a minimum of 4 weeks before the prescreening visit.
    c. Reversibility of disease: The patient has demonstrated at least 12% reversibility and 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2 4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex actuator) or equivalent at SV. Reversibility values of 11.50 11.99 will be rounded to 12. A documented historical reversibility, including flow loops, of at least 12% and 200 mL increase from baseline FEV1 (patients age 18 and older) to a beta agonist in the previous 12 months before SV is also acceptable. Note: Patients who do not qualify for the study due to either failure to meet baseline spirometry, failure to meet reversibility, or failure to achieve spirometry consistent with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria will be permitted to perform a retest once within 7 days or will be permitted to rescreen once at least 7 days after the date of screening.
    d. Written informed consent/assent is obtained. For adult patients (age 18 and older, or as applicable per local regulations), the written informed consent form must be signed and dated by the patient before conducting any study related procedure. For minor patients (ages 12 to 17 years, or as applicable per local regulations), the written informed consent form must be signed and dated by the parent/legal guardian and the written informed assent form must be signed and dated by the patient before conducting any study related procedure.
    e. The patient is a male or female 12 years of age or older as of the visit when informed consent/assent is signed (screening or prescreening visit, as applicable).
    f. Asthma diagnosis: The patient has a diagnosis of asthma as defined by the NIH. The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days.
    g. The patient is able to perform acceptable and repeatable spirometry consistent with the ATS/ERS 2005 criteria.
    h. The patient is able to perform PEF with a hand held peak flow meter.
    i. The patient is able to use an MDI device without a spacer device and a BAI device.
    j. The patient is able to withhold (as judged by the investigator) his or her regimen of ICS or study drug, and rescue medication for at least 6 hours before SV and the treatment visits in which spirometry will be conducted (SV, randomization visit [RV], treatment visit [TV] 1, TV2, TV3, and TV4).
    k. The patient/parent/guardian/caregiver is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements.
    l. If patient is a female, she is currently not pregnant, breast feeding, or attempting to become pregnant (for 30 days before SV and throughout the duration of the study and for 30 days after the patient's last visit), or is of non childbearing potential, as defined by any of the following:
    -premenarche
    -at least 1 year postmenopausal
    -surgically sterile
    -congenitally sterile
    -diagnosed as infertile and not undergoing treatment to reverse infertility

    OR, if of childbearing potential, has a negative serum pregnancy test and is willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:
    -systemic contraception used for at least 1 month before screening, including birth control pills, transdermal patch, vaginal ring, levonorgestrel implant, or injectable progesterone
    -double barrier method (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide)
    -intrauterine device (IUD) with a low failure rate (defined as less than 1% per year)
    -monogamous with a vasectomized male partner or exclusively has same sex partners
    OR, if of childbearing potential, is not sexually active or has a negative serum pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event she becomes sexually active.
    If male and sexually active, the patient is willing to commit to an acceptable method of birth control for the duration of the study or exclusively has same sex partners.
    E.4Principal exclusion criteria
    a. The patient has a history of life threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
    b. The patient is pregnant or lactating, or plans to become pregnant or to donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days after the patient’s last study related visit (for eligible patients only, if applicable). Eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. Any patient becoming pregnant during the study will be withdrawn from the study.
    c. The patient has participated in any investigational drug study within the 30 days preceding SV (or prescreening visit, as applicable), or plans to participate in another investigational drug study at any time during this study.
    d. The patient has previously participated in a beclomethasone dipropionate BAI study as a randomized patient.
    e. The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
    f. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, clarithromycin) within 30 days before SV or plans to be treated with any strong CYP3A4 inhibitor during the study.
    g. The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before SV.
    h. The patient currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). A patient may not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco).
    i. The patient has a culture documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before SV.
    j. The patient has a history of alcohol or drug abuse within 2 years preceding SV.
    k. The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV
    l. Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients who initiated immunotherapy 90 days or more before the screening visit (SV) and have been on a stable (maintenance) dose for 30 days or more prior to SV may be considered for inclusion.
    m. The patient has used immunosuppressive medications within 4 weeks before SV.
    n. The patient is unable to tolerate or unwilling to comply with the required washout periods and withholding of all applicable medications.
    o. The patient has untreated oral candidiasis at SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study.
    p. The patient has had a positive test for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C infection.
    q. The patient is either an employee or an immediate relative of an employee of the clinical investigational center.
    r. A member of the patient’s household is participating in the study at the same time.
    s. The patient has historic or current evidence of a clinically significant disease, including but not limited to the following:
    -cardiovascular conditions (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, coronary artery disease)
    -hepatic, renal, hematologic, neuropsychologic, or endocrine conditions (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, Cushing’s syndrome)
    -gastrointestinal conditions (eg, poorly controlled peptic ulcer disease, gastroesophageal reflux disease)
    -pulmonary conditions (eg, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia)
    Note: Chronic obstructive pulmonary disease/chronic bronchitis is expressly prohibited.
    -current malignancy, excluding basal cell carcinoma
    -current or untreated tuberculosis
    -uncontrolled hypertension (systolic blood pressure of at least 160 mm Hg or diastolic blood pressure over 100 mm Hg)
    -stroke within 3 months before SV
    -immunologic compromise
    -ocular disturbances, including glaucoma, cataract, or herpes simplex infection
    -Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable for this study is the change from baseline in trough morning (pre dose and pre rescue bronchodilator) FEV1 over the 12 week treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary efficacy endpoint timeline is over the 12-week treatment period.
    E.5.2Secondary end point(s)
    The secondary endpoints include:
    • Change from baseline in weekly average of daily trough morning (pre dose and pre rescue bronchodilator) PEF over the 12 week treatment period
    • Change from baseline in weekly average of daily evening PEF over the 12 week treatment period
    • Time to patient withdrawal due to meeting stopping criteria for worsening asthma during the 12 week treatment period
    • Change from baseline in the weekly average of total daily (24 hour) use of albuterol/salbutamol inhalation aerosol (number of inhalations) over weeks 1-12
    • Change from baseline in the weekly average of the total daily asthma symptom score (the total daily asthma symptom score is the average of the daytime and nighttime scores) over weeks 1-12
    • Change from baseline in the percentage of rescue free days (defined as 24 hour periods with no rescue medication usage) during the 12 week treatment period
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Change from baseline in weekly average of daily trough morning (pre dose and pre rescue bronchodilator) PEF over the 12 week treatment period
    • Change from baseline in weekly average of daily evening PEF over the 12 week treatment period
    • Time to patient withdrawal due to meeting stopping criteria for worsening asthma during the 12 week treatment period
    • Change from baseline in the weekly average of total daily (24 hour) use of albuterol/salbutamol inhalation aerosol (number of inhalations) over weeks 1-12
    • Change from baseline in the weekly average of the total daily asthma symptom score over weeks 1-12
    • Change from baseline in the percentage of rescue free days during the 12 week treatment period
    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 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.8.2.4Number of treatment arms in the trial5
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Germany
    Hungary
    Poland
    United States
    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
    LVLS
    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 months5
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 5
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 77
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-04-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 500
    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)
    Patient will continue on normal standard of care.
    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 Decision2014-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-12
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