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    Summary
    EudraCT Number:2010-023382-22
    Sponsor's Protocol Code Number:9521-CL-0002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-06-06
    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 number2010-023382-22
    A.3Full title of the trial
    Phase I/II, multi-center, open label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ASP9521 in patients with metastatic castrate-resistant prostate cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) Patients
    A.3.2Name or abbreviated title of the trial where available
    PHASE I/II STUDY OF ASP9521 IN CRPC PATIENTS
    A.4.1Sponsor's protocol code number9521-CL-0002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01352208
    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 SponsorAstellas Pharma Europe B.V. (APEB)
    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 supportAstellas Pharma Europe B.V. (APEB)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V. (APEB)
    B.5.2Functional name of contact pointService Desk
    B.5.3 Address:
    B.5.3.1Street AddressGlobal Development Operations, Elisabethhof 19
    B.5.3.2Town/ cityLeiderdorp
    B.5.3.3Post code2353 EW
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 (0)715 455 878
    B.5.5Fax number+31 (0)715 455 224
    B.5.6E-mailcontact@nl.astellas.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 nameASP9521
    D.3.2Product code ASP9521
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNINN not available
    D.3.9.2Current sponsor codeASP9521
    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) 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 nameASP9521
    D.3.2Product code ASP9521
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNINN not available
    D.3.9.2Current sponsor codeASP9521
    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) 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 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 nameASP9521
    D.3.2Product code ASP9521
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNINN not available
    D.3.9.2Current sponsor codeASP9521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    metastatic castrate-resistant prostate cancer
    E.1.1.1Medical condition in easily understood language
    Metastatic castrate resistant prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10036911
    E.1.2Term Prostate cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 phase I/II three-part study is to evaluate the safety, tolerability, pharmacokineticpharmacodynamic (PK-PD) profile, maximum tolerated dose and antitumor activity of once daily dosing with ASP9521 in patients with metastatic castrate resistant prostate cancer (CRPC) whose cancers are resistant to one
    or more lines of hormonal treatment/androgen deprivation therapy (stratified into 2 groups: chemotherapy-naïve or post chemotherapy).
    Part 1
    -to evaluate the safety and tolerability of ASP9521.
    Part II
    -To evaluate PSA decline of ≥50% from baseline after 12 weeks of daily dosing with ASP9521.
    Part III
    -To evaluate the PK of single doses of ASP9521 under fed and fasted conditions.
    E.2.2Secondary objectives of the trial
    Part I
    -To determine the maximum tolerated dose, if possible.
    -To evaluate prostate specific antigen decline of ≥50% from baseline after 12 weeks of daily dosing with ASP9521.
    -To evaluate the PK of ASP9521 following single and multiple dose administration.
    -To evaluate the pharmacodynamics of ASP9521.
    Part II
    -To evaluate the safety and tolerability of ASP9521.
    -To evaluate the PK of ASP9521 following multiple dose administration.
    -To evaluate the PD effect of ASP9521.
    -To evaluate the effect of ASP9521 on pain palliation.
    -To explore pharmacogenetic differences.
    Part III
    -To evaluate the safety and tolerability of single doses of ASP9521 under fed and fasted conditions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient is eligible for the study if all of the following apply:
    1. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations must be obtained from the patient or legally authorized representative prior to any study-related procedures.
    2. Male aged 18 years or older. Female sexual partners of male participants in the study must be non-fertile, i.e., surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies. Adequate contraceptive methods are defined as: sexual abstinence from the day of partner’s dosing until 3 months after the last dose; the use of a condom in addition to having their partner use another acceptable method (oral or injectable hormonal contraceptives, contraceptive patch, intra-uterine devices, vaginal hormonal rings, or sterilization by surgery, a vaginal diaphragm or cervical caps) during the study and for up to 3 months after the last dose; patient’s sexual partner is of non-child bearing potential i.e., post-menopausal, surgically sterilized (e.g., tubal ligation), or hysterectomy in medical history.
    3. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
    4. Metastatic disease documented by 2 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
    5. Ongoing androgen deprivation with LHRH agonist/antagonist therapy or bilateral orchiectomy. For patients who have not had an orchiectomy, there must be a plan to maintain effective LHRH agonist/antagonist therapy for the duration of the study.
    6. Serum testosterone <1.7 nmol/L (50 ng/dL) at screening.
    7. Patients receiving bisphosphonates or other approved bone targeting therapy must have been on stable doses for at least 4 weeks prior to screening.
    8. Progressive disease at study entry defined as one or more of the following 3 criteria occurring in the setting of castrate levels of testosterone:
    ● PSA progression defined by a minimum of 2 rising PSA levels with an interval of >1 week between each determination. The PSA value at screening should be >2 ng/mL.
    ● Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST). Measurable disease is not required for entry. Lymph nodes >20 mm are considered measurable disease.
    ● Bone disease progression defined by at least 2 new lesions on bone scan.
    9. Life expectancy of >6 months according to the investigator’s judgment.
    The following inclusion criteria must be fulfilled by chemotherapy-naïve patients:
    10. Eastern Cooperative Oncology Group (ECOG) scores of 0 to 1.
    11. Asymptomatic or controlled symptomatic patients with metastatic CRPC who have failed one or more lines of hormonal treatment/androgen deprivation therapy but have not received chemotherapy or have refused chemotherapy.
    12. No prior chemotherapy for prostate cancer.
    13. Anti-androgen withdrawal patients receiving an anti androgen as part of primary androgen ablation must demonstrate disease progression following discontinuation of anti-androgen (>4 weeks since last flutamide dose or >6 weeks since last bicalutamide or nilutamide dose).
    The following inclusion criteria must be fulfilled by post chemotherapy patients:
    14. ECOG scores of 0 to 2.
    15. No more than 2 prior regimens of chemotherapy for prostate cancer, of which one is docetaxel-based to have been received at least 4 weeks prior to screening.
    E.4Principal exclusion criteria
    Patients will be excluded from participation in the study if any of the following apply:
    1. Concomitant treatment with the following is prohibited according to stratification as chemotherapy-naïve or post-chemotherapy patients:
    ● Chemotherapy-naïve patients:
    ● All chemotherapeutic agents.
    ● All biologic agents (except for sipuleucel T [Provenge®]), or other agents with anti-tumor activity against prostate cancer, including 5 alpha reductase inhibitors, androgens (e.g., testosterone), cytoproterone acetate and all other progestational agents, estrogens, and flutamide within 4 weeks prior to day of first dose of ASP9521.
    ● Bicalutamide or nilutamide within 6 weeks prior to day of first dose of ASP9521.
    ● Treatment with estramustine.
    ● Ketoconazole for treatment of prostate cancer.
    ● Treatment with abiraterone.
    ● Post-chemotherapy patients:
    ● All biologic agents (except for sipuleucel T [Provenge®]), or other agents with anti-tumor activity against prostate cancer, including 5 alpha reductase inhibitors, androgens (e.g., testosterone), progestational agents, estrogens, flutamide within 4 weeks prior to day of first dose of ASP9521.
    ● Bicalutamide or nilutamide within 6 weeks prior to day of first dose of ASP9521.
    ● Ketoconazole for treatment of prostate cancer.
    ● Treatment with abiraterone.
    2. Use of herbal products that may have hormonal anti prostate cancer activity and/or are known to decrease PSA levels or Prednisolone > 10 mg (or an equivalent) for the treatment of prostate cancer within 4 weeks of day of first dose of ASP9521, or plans to initiate the above within the study period.
    3. Radiation therapy for treatment of the prostate within 3 months prior to screening.
    4. Radiation therapy for the treatment of metastases within 3 weeks (if single fraction of radiotherapy then within 2 weeks) and radionuclide therapy for the treatment of metastases within 4 weeks prior to screening.
    5. Major surgery within 2 months prior to screening.
    6. Known or suspected intracerebral disease or brain metastasis.
    7. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer.
    8. Gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease).
    9. Any of the following significant ophthalmological abnormalities:
    a. Abnormal intraocular pressure (IOP).
    b. Abnormal fundus, like age-related macular degeneration (AMD) or other retinal damage
    10. Significant cardiovascular disease including:
    ● Myocardial infarction within 6 months prior to screening.
    ● Uncontrolled angina within 3 months prior to screening.
    ● Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥45%.
    ● History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes).
    ● History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place.
    ● Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) >170 mmHg or diastolic BP >105 mmHg at screening.
    11. Concurrent disease or any clinically significant abnormality following the investigator’s review of the pre-study physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory tests, which in the judgment of the investigator would interfere with the patient’s participation in this study or evaluation of study results.
    12. Absolute neutrophil count <1,500/µL, platelet count <100,000/µL, and hemoglobin <5.6 mmol/L (9 g/dL) at screening; (NOTE: patients must not have received any growth factors or blood transfusions within 7 days of the hematologic laboratory values obtained at screening).
    13. Total bilirubin >1.5 times the upper limit of normal (ULN) at screening. This will not apply to patients with Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly uncongugated in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with the sponsor.
    14. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times ULN or >5 times ULN in the presence of liver metastases at screening.
    15. Creatinine >177 µmol/L (2 mg/dL) at screening.
    16. Known or suspected hypersensitivity to ASP9521, or any components of the formulation used.
    17. Use of an investigational agent within 4 weeks prior to treatment allocation or a period required by local regulation, whichever is longer.
    18. Prior use, or participation in a clinical study, of an investigational agent that blocks androgen synthesis or targets the androgen receptor (like MDV3100 and TAK700).
    E.5 End points
    E.5.1Primary end point(s)
    -Safety and tolerability will be assessed in all patients by descriptive analysis.
    -The primary efficacy endpoint will be the proportion of patients in the full analysis set showing PSA decline of >50% from baseline at week 12, by dose and patient group (i.e., chemotherapy-native versus post chemotherapy patients)
    -The ASP9521 pharmacokinetics after single dose.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety variables- frequency and severity of AEs, clinical laboratory tests, physical examinations, vital signs, 12-lead and Holter ECGs will be collected as stated in protocol schedule of assessment. Adverse events will be collected from the time of signed informed consent, and will be assessed each time the patient visits the clinic.
    The time point of evaluation of the primary efficacy endpoint is at the week 13 visit.
    The ASP9521 pharmacokinetics after single dose.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoint will be determined in all study parts, based on the proportion of patients showing RECIST objective response (partial or complete response) will be reported by dose and patient group. In Part I, it will be done on the safety analysis set. In the expanded dose levels of Part I+II and in Part III, it will be calculated on the per protocol set and the full analysis set. The 95% CI will be reported in the Part I+II analysis.
    In addition in all parts PK and PD will be analyzed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints for secondary endpoints are given in the protocol.
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    DOSE ESCALATION
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    End of study is defined as last patient's last visit.
    When sponsor is aware of information regarding quality,efficacy,and safety of the drug,and other information that may affect proper trial conduct,the sponsor may discontinue the study and send a written notice of the discontinuation with the reasons to the investigator.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 156
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 186
    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)
    It is not different then expected normal treatment for this indication.
    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 Decision2011-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-10-03
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