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    The EU Clinical Trials Register currently displays   35185   clinical trials with a EudraCT protocol, of which   5753   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-015082-31
    Sponsor's Protocol Code Number:M10-757
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-015082-31
    A.3Full title of the trial
    A Phase 2 Randomized Clinical Trial of ABT-888 in Combination with Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Subjects with Recurrent High Grade Serous Ovarian Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial of ABT-888 in Combination with Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Subjects with Recurrent High Grade Serous Ovarian Cancer
    A.4.1Sponsor's protocol code numberM10-757
    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 SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbott Laboratories
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Laboratories
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall Road,
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0) 1628 644475
    B.5.5Fax number+44 (0) 1628 644330
    B.5.6E-maileuclinicaltrials@abbott.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/830
    D.3 Description of the IMP
    D.3.1Product nameABT-888
    D.3.2Product code ABT-888
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVeliparib
    D.3.9.1CAS number 912444-00-9
    D.3.9.2Current sponsor codeABT-888
    D.3.9.3Other descriptive name1H-Benzimidazole-7-carboxamide, 2-[(2R)-2-methyl-2-pyrrolidinyl]-
    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) 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 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 Yes
    D.2.1.1.1Trade name Temodal Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderSP Europe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTEMOZOLOMIDE
    D.3.9.1CAS number 85622-93-1
    D.3.9.3Other descriptive nameTMZ
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTEMOZOLOMIDE
    D.3.9.1CAS number 85622-93-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTEMOZOLOMIDE
    D.3.9.1CAS number 85622-93-1
    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 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 Caelyx 2mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderSP Europe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDOXORUBICIN HYDROCHLORIDE
    D.3.9.1CAS number 25316-40-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent high grade serous ovarian cancer.
    E.1.1.1Medical condition in easily understood language
    Recurrent High Grade Serous Ovarian Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the objective response rate (ORR) of ABT-888 in combination with Temozolomide (TMZ) compared to Pegylated Liposomal Doxorubicin (PLD) alone in subjects with recurrent high grade serous ovarian cancer.
    E.2.2Secondary objectives of the trial
    To evaluate progression free survival (PFS), time to progression (TTP), overall survival (OS), 12-month survival rate, 6-month progression free survival rate, duration of response, safety, and tolerability.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subjects will have the option to participate in the following substudies:

    a) Tissue sample collection: Subjects may consent to providing fixed tissue samples taken from a most recent pathological analysis. These tissue samples may help researchers develop a diagnostic test to identify patients most likely to respond to the drug.

    b) Fluid aspirates collection: Subjects may consent to providing fixed samples taken from a most recent pathological analysis, if a paracentesis or thoracentesis is performed as standard of care treatment. These samples may help researchers develop a diagnostic test to identify patients most likely to respond to the drug.

    c) Genetic sub-study: Subjects may consent to an additional blood draw that will be used for genetic testing to help determine why some ovarian cancer patients may benefit from taking ABT-888 more than others do.



    E.3Principal inclusion criteria
    1. Subject must be at least 18 years of age.
    2. Subject must have histologically (or cytologically) confirmed recurrent high grade
    serous ovarian, fallopian tube, or primary peritoneal cancer.
    3. Subjects must have had at least 1 platinum containing chemotherapy regimen for ovarian cancer and no more than a total of 3 DNA damaging or cytotoxic regimens in the past 5 years. Less than a full dose of a DNA damaging agent, possibly due to reasons such as toxicity or documented allergic reaction will not be counted toward the limit of 3. Previous treatments with biologic agents (including catumaxomab, tigatuzuzumab, abagovomab and bevacizumab), vaccines, immunostimulants, hormonal agents and signal transduction inhibitors (e.g., pazoparib, sorafenib, sunitinib, temsirolimus) are allowed and are not counted towards the limit of 3.
    4. Subjects who are resistant to platinum-based therapy; or sensitive to, but are
    unable to tolerate platinum-based therapy (i.e., deemed toxic or have a
    documented platinum allergy). Subjects must have at least a ≥ 3 month treatment
    free interval from the last dose of platinum based therapy. They may have
    received other therapy since their last platinum therapy prior to enrolling in this
    study.
    5. Subject must be eligible to receive PLD treatment (e.g., no allergic reaction,
    normal cardiac function).
    6. Subject has either:
    ● Measurable disease, defined as at least 1 unidimensionally measurable lesion
    on a CT scan as defined by RECIST version 1.130 OR
    ● Non-measurable disease with an elevation of serum CA-125 level by GCIG
    criteria (baseline sample is at least twice the upper limit of normal and within
    2 weeks prior to starting treatment).31
    7. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
    8. Subject must have adequate hematologic, renal and hepatic function per
    institutional normal range as follows:
    ● Bone Marrow: Absolute neutrophil count (ANC ≥ 1,500/mm3 (1.5 × 109/L);
    Platelets ≥ 100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.5 g/dL (1.4 mmol/L);
    ● Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) range
    OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine
    levels above institutional normal;
    ● Hepatic function: AST and/or ALT ≤ 2.5 × the ULN range. For subjects with
    liver metastases, AST and/or ALT < 5 × the ULN range; Bilirubin ≤ 1.5 × the
    ULN range.
    ● Partial Thromboplastin Time (PTT) must be ≤ 1.5 × the ULN range and INR
    < 1.5. Subjects on anticoagulant therapy (such as Coumadin) are allowed on
    study and will have an appropriate PTT and INR as determined by the
    Investigator.
    9. Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study
    participation and for 90 days following completion of therapy. Women of
    childbearing potential must have a negative serum pregnancy test within 21 days
    prior to initiation of treatment and a negative urine pregnancy test on Cycle 1
    Day 1 and/or post menopausal women must be amenorrheic for at least 12 months
    to be considered of non-childbearing potential.
    ● Total abstinence from sexual intercourse (minimum one complete menstrual
    cycle);
    ● Vasectomized partner;
    ● Hormonal contraceptives (oral, parenteral or transdermal) for at least
    3 months prior to study drug administration;
    ● Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal
    ring with spermicidal jellies or cream);
    ● IUD (Intrauterine Device);
    10. Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by an
    Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to
    the initiation of any screening or study-specific procedures.
    E.4Principal exclusion criteria
    1. Subject has previously been treated with a PARP inhibitor except as a single dose
    from the CTEP Phase 0 (A06-161) study of ABT-888.
    2. Subjects who have a history of hypersensitive reaction to the conventional
    formulation of doxorubicin HCL, or the components of PLD.
    3. Subject has received anticancer agent(s) or an investigational agent within 28 days prior to study drug administration. Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.
    4. Subject has undergone major surgery within the previous 28 days prior to study
    drug administration.
    5. Subject with prior radiotherapy to any portion of the abdominal cavity and pelvis,
    unless for the treatment of ovarian, primary peritoneal or fallopian tube cancer.
    Subject must have completed radiation at least 28 days prior to study drug
    administration and have measurable disease outside the radiation field or
    documented progression of lesions within a previously radiated field.
    6. Subject with a known history of brain metastases.
    7. Clinically significant and uncontrolled major medical condition(s) including but
    not limited to:
    ● Active uncontrolled infection;
    ● Symptomatic congestive heart failure;
    ● Unstable angina pectoris or cardiac arrhythmia;
    ● Psychiatric illness/social situation that would limit compliance with study
    requirements.
    ● Any medical condition, which in the opinion of the Study Investigator, places
    the subject at an unacceptably high risk for toxicities.
    8. Subject is pregnant or lactating.
    9. Subject has been treated or hospitalized for bowel obstruction within 28 days prior to study drug administration.
    10. Subject who requires parenteral nutrition or tube feeding and has evidence of
    partial bowel obstruction or perforation.
    11. The subject has had another active malignancy within the past 5 years except for
    any cancer in situ considered cured or non-melanoma carcinoma of the skin.
    Questions regarding the inclusion of individual subject are to be directed to the
    Abbott Medical Monitor.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), time to progression (TTP), Overall Survival (OS), 12-month survival rate, 6-month PFS rate, duration of response and ECOG performance status. Analyses of these endpoints are described in Section 8.1.2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening to survival follow-up (approx. every 12 weeks or as needed for up to 3 yrs)
    E.5.2Secondary end point(s)
    Progression Free Survival, Time to Progression, Overall Survival, 12-month Survival Rate, 6-month Progression Survival Rate, Duration of Response, Safety and Tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening to survival follow-up (approx. every 12 weeks or as needed for up to 3 yrs)
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Argentina
    Australia
    Canada
    Israel
    New Zealand
    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
    The end-of-study is defined as the date of the last subject's last visit, or last follow- up visit, whichever is longer.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 150
    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)
    Upon completion of the study, the subject will be treated in accrodance with the investigator's best clincal judgement
    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 Decision2010-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-25
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