Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39242   clinical trials with a EudraCT protocol, of which   6428   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-003062-32
    Sponsor's Protocol Code Number:B1271004
    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:2012-01-12
    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 number2011-003062-32
    A.3Full title of the trial
    A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF THE EFFICACY OF PF-04691502 AND PF-05212384 IN PATIENTS WITH RECURRENT ENDOMETRIAL CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 comparative study of two investigational agents, PF04681502 and PF05212384 respectively, in women with advanced tumour of the uterus.
    A.4.1Sponsor's protocol code numberB1271004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01420081
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    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 supportPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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.3.2Product code PF-04691502
    D.3.4Pharmaceutical form 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 INNPF-04691502
    D.3.9.2Current sponsor codePF-04691502
    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.3.2Product code PF-04691502
    D.3.4Pharmaceutical form 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 INNPF-04691502
    D.3.9.2Current sponsor codePF-04691502
    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) 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.3.2Product code PF-05212384
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-05212384
    D.3.9.2Current sponsor codePF-05212384
    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
    RECURRENT ENDOMETRIAL CANCER
    E.1.1.1Medical condition in easily understood language
    advanced tumour of the uterus
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10014736
    E.1.2Term Endometrial cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Arm A: To assess the clinical benefit rate (CBR) of the oral PI3K/mTOR inhibitor PF-04691502 in patients with recurrent endometrial cancer which is classified as PI3K basal.
    • Arm B: To assess the clinical benefit rate of the intravenous PI3K/mTOR inhibitor PF-05212384 in patients with recurrent endometrial cancer that is classified as PI3K basal.
    • Arm C: To assess the clinical benefit rate of the oral PI3K/mTOR inhibitor PF-04691502 in patients with recurrent endometrial cancer which is classified as PI3K activated.
    • Arm D: To assess the clinical benefit rate of the intravenous PI3K/mTOR inhibitor PF-05212384 in patients with recurrent endometrial cancer that is classified as PI3K activated.

    As of 09 October 2012, Pfizer decided to discontinue the clinical development of PF-04691502 and stop further enrollment of patients into study Arms A and C.
    E.2.2Secondary objectives of the trial
    • To evaluate the anti-tumor activity of PF-04691502 and PF-05212384 individually in patients with PI3K basal and PI3K activated tumors.
    • To further characterize the safety of PF-04691502 and PF-05212384 individually.
    • To characterize the pharmacokinetics for PF-04691502 and PF-05212384 individually.
    • To characterize the pharmacodynamic effects of PF-04691502 and PF-05212384 individually.
    • To characterize genetic and protein biomarkers of PI3K pathway alterations (PIK3CA mutation, PTEN protein levels, etc) in FFPE tumor specimens.
    • To explore the modulation of PI3K and mTOR pathways in pre and post dosing biopsies.

    As of 09 October 2012, Pfizer decided to discontinue the clinical development of PF-04691502 and stop further enrollment of patients into study Arms A and C.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Women aged ≥18 years.
    2. Histologically or cytologically confirmed diagnosis of endometrial carcinoma.
    3. Recurrent endometrial cancer that is not amenable to curative surgery and/or radiation.
    4. All patients must have tumor tissue available for central analysis of PI3K pathway activation status, performed by the sponsor-identified central laboratory prior to enrollment. Formalin fixed paraffin embedded (FFPE) block preferred, but freshly cut slides are acceptable.
    5. Disease progression on or following a platinum containing chemotherapy regimen (alone or in combination with radiation or hormonal therapy) for the treatment of endometrial cancer in the adjuvant or metastatic setting. Patients must not have progression during or immediately following (within approximately 3 months) this regimen.
    6. At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, V 1.1. Lesion must not have been previously irradiated.
    7. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 (not declining within 2 weeks prior to signing of informed consent).
    8. Adequate Bone Marrow Function, including:
    a. Absolute Neutrophil Count (ANC) ≥1,500/mm3 or ≥1.5 x 1000000000/L.
    b. Platelets ≥100,000/mm3 or ≥100 x 1000000000/L.
    c. Hemoglobin ≥9 g/dL.
    9. Adequate Renal Function, including:
    a. Serum creatinine ≤1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution.
    10. Adequate Liver Function, including:
    a. Total serum bilirubin ≤1.5 x ULN or ≤1.0 mg/dL.
    b. Aspartate and Alanine Aminotransferase (AST & ALT) ≤2.5 x ULN; ≤5.0 x ULN if there is liver involvement.
    c. Alkaline phosphatase ≤2.5 x ULN; (≤5 x ULN in case of bone metastasis).
    11. Adequate blood glucose control, as evidenced by fasting blood glucose of ≤126 mg/dL.
    12. Adequate Cardiac Function, including 12-Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention.
    13. Resolved acute effects of any prior therapy to baseline severity or Grade ≤1 CTC AE except for AEs not constituting a safety risk by investigator judgement.
    14. Serum/urine pregnancy test (for females of childbearing potential) prior to strating treatment. For patients participating in the PK lead in sub-study, pregnancy test must be performed immediately before the single dose.
    Female patients of childbearing potential must agree to use two highly effective methods of contraception throughout the study and for at least 90 days after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active. Female patients who are not of childbearing potential (ie, meet at least one of the following criteria):
    - Have undergone hysterectomy or bilateral oophorectomy;
    - Have medically confirmed ovarian failure or
    - Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause.
    15. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    16. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Patients who are investigational site staff members and directly involved with the conduct of the trial or patients who are Pfizer employees directly involved in the conduct of the trial.
    2. More than 2 prior cytotoxic chemotherapy regimens for endometrial carcinomain in the adjuvant or metastatic setting. Prior hormonal or biologic therapy is acceptable.
    3. Patients with known active brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable.
    4. Chemotherapy, radiotherapy (other than palliative radiotherapy to lesions that will not be followed for tumor assessment on this study, ie, non target lesions), hormonal, biological or investigational agents within 2 weeks of first dose of study drug (6 weeks for mitomycin C or nitrosoureas).
    5. Any surgery (not including minor procedures such as lymph node biopsy, needle biopsy, and/or placement of port-a-cath) within 4 weeks of first dose of study drug; or not fully recovered from any side effects of previous procedures.
    6. Prior therapy with an agent that is known or proposed to be active by action on PI3K, and/or mTOR, and/or AKT.
    7. Uncontrolled diabetes mellitus defined as HbA1c > 8%.
    8. Current use or anticipated need for food or drugs that are known potent CYP3A4 inhibitors. Because inhibition of CYP3A4 isoenzymes may increase study drug exposure leading to a potential increases in toxicities, the use of known strong inhibitors (Strong CYP3A4 Inhibitors: grapefruit juice or grapefruit/grapefruit related citrus fruits (eg, Seville oranges, pomelos), ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, erythromycin, clarithromycin, telithromycin, varapamil, indinavir, saquinavir, ritonavir, nelfinavir, nefazodone, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine, troleandomycin, mibefradil, conivaptan) are not permitted from 10 days prior to the first dose of study drug until study treatment discontinuation.
    9. Current or anticipated need for food or drugs that are known potent CYP3A4 inducers. Study drug metabolism may be induced when taking strong CYP3A4 inducers (eg, phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, clevidipine, St. John’s Wort) resulting in reduced plasma concentrations. Therefore co administration of study drug in combination with these and other strong CYP3A4 inducers is not permitted from 10 days prior to the first dose of stud drug until study treatment discontinuation.
    10. Concurrent administration of herbal preparations.
    11. Breast feeding: No studies have been conducted in humans to assess the impact of PF 04691502 or PF-05212384 on milk production, its presence in breast milk and its effects on the breast fed child. Because drugs are commonly excreted in human milk and because of the potential for serious adverse reactions in nursing infants, lactating female patients are excluded from this study.
    12. Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug, such as the inability to take oral medication in tablet or capsule form and malabsorption syndrome.
    13. Any mental disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol.
    14. Other severe acute or chronic medical condition or psychiatric condition (including cancer other than the cancer under study) or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
    15. Participation in other studies within 2 weeks before the current study begins and/or during study participation.
    16. Recent or active suicidal ideation or behavior.
    E.5 End points
    E.5.1Primary end point(s)
    • Clinical Benefit Response (CBR) (CR+PR+SD 16 weeks)

    As of 09 October 2012, Pfizer decided to discontinue the clinical development of PF-04691502 and stop further enrollment of patients into study Arms A and C. Therefore, although tumor assessment data for Arms A and C will be included as a listing in the final clinical study report, a formal efficacy analysis for those patients taking PF-04691502 will not be performed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Arms B and D only: Radiological tumor assessments will be conducted at baseline, during treatment as specified in the Schedule of Events, whenever disease
    progression is suspected (eg, symptomatic deterioration), and at the time of withdrawal from
    the study (if not done in the previous 6 weeks).
    Assessment of response will be made using RECIST version 1.1.
    E.5.2Secondary end point(s)
    • Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1.
    • Overall Survival (OS).
    • Progression Free Survival (PFS).
    • PFS at 6 months.
    • Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.0), timing, seriousness and relationship to study therapy.
    • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v. 4.0) and timing.
    • Pharmacodynamic endpoints: serum glucose, insulin, HbA1c, cholesterol, triglycerides.
    • Expression and/or phosphorylation in biopsied tumor tissue of PI3K pathway proteins (such as p-AKT, p-S6, p-S6K,p- mTOR, p-PRAS40, stathmin).
    • Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, PTEN protein levels, PIK3CA gene amplification, stathmin.
    • Pharmacokinetics of PF-04691502 and PF-05212384.

    As of 09 October 2012, Pfizer decided to discontinue the clinical development of PF-04691502 and stop further enrollment of patients into study Arms A and C.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Arms B and D only: Trial procedures are described in the ASSESSMENTS Section
    and in the Schedule of Activities. Safety laboratory studies (hematology, blood chemistry,
    urinalysis, pregnancy test (except for screen/baseline) if needed) and tumor assessments may
    be done up to 96 hours prior to scheduled Day 1 visit on any cycle to facilitate availability of
    results to investigator at the time of clinic visit.
    Exploratory "Omics" analyses will be conducted as described in the Molecular Supplement.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA42
    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
    Australia
    Austria
    Canada
    France
    Germany
    Japan
    Philippines
    Poland
    Russian Federation
    Slovakia
    Spain
    Switzerland
    Taiwan
    Turkey
    United Kingdom
    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
    End of Trial in all participating countries is defined as last patient having the End of Treatment visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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 months0
    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: 93
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 159
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    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 No
    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 142
    F.4.2.2In the whole clinical trial 252
    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)
    none
    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 Decision2012-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-25
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA