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    Summary
    EudraCT Number:2004-005276-16
    Sponsor's Protocol Code Number:ET743-OVA-301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2004-005276-16
    A.3Full title of the trial
    An open-label multicenter randomized Phase 3 study comparing the combination of DOXIL/CAELYX and YONDELIS with DOXIL/CAELYX alone in subjects with advanced relapsed ovarian cancer
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberET743-OVA-301
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorPHARMA MAR
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/171
    D.3 Description of the IMP
    D.3.1Product nametrabectedin
    D.3.2Product code ET-743; R279741; RWJ-680581
    D.3.4Pharmaceutical form Powder 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 INNTrabectedin
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CAELYX*INFUS 1FL 2MG/ML 10ML
    D.2.1.1.2Name of the Marketing Authorisation holderSCHERING PLOUGH SpA *
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder 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
    D.3.9.1CAS number 25316-40-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CAELYX*INFUS 1FL 2MG/ML 25ML
    D.2.1.1.2Name of the Marketing Authorisation holderSCHERING PLOUGH SpA *
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder 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
    D.3.9.1CAS number 25316-40-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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: 4
    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/3/03/171
    D.3 Description of the IMP
    D.3.1Product nametrabectedin
    D.3.2Product code ET-743; R279741; RWJ-680581
    D.3.4Pharmaceutical form Powder 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 INNTrabectedin
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Female subjects 18 years of age or older with advanced ovarian cancer who have met the specific inclusion and exclusion criteria will be enrolled in this study. Subjects must have histologically proven epithelial ovarian or primary peritoneal cancer previously treated with only 1 chemotherapy regimen (platinum-based) and have experienced either recurrence or progression more than 6 months after the beginning (first dose) of the initial line of platinum-based chemotherapy for ovarian cancer.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian cancer metastatic
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate that the combination of YONDELIS (trabectedin) for intravenous infusion + DOXIL/CAELYX (doxorubicin HCl liposome injection, hereafter referred to as DOXIL) improves overall survival (OS) over DOXIL alone in the management of ovarian cancer in second-line therapy. Another key primary objective of the study is to demonstrate that the combination of YONDELIS (trabectedin) for intravenous infusion + DOXIL/CAELYX improves progression free survival (PFS) over DOXIL alone in the management of ovarian cancer in second line therapy.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to demonstrate an increase of objective response rate (ORR) and to compare the safety profiles of the combination and monotherapy with DOXIL alone. The pharmacokinetics of DOXIL and YONDELIS in each treatment group will be characterized.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inclusion Criteria* Subjects must satisfy all of the following criteria to be enrolled in the study: Female, age 18 or older Histologically proven epithelial ovarian cancer or primary peritoneal cancer Prior treatment with only one chemotherapy regimen (including adjuvant therapy), which must be platinum-based and may include sequential maintenance therapy (no gaps in administration of initial therapy may occur other than a delay no longer than 1 cycle for treatment toxicity). Eastern Cooperative Oncology Group performance status is equal or less than 2 Estimated life expectancy of at least 3 months Recurrence or progression after 6 full cycles of a complete 6 cycle initial treatment regimen or 6 months after the beginning (first dose) of the initial treatment line of platinum-based chemotherapy for ovarian cancer to include &#8722; Platinum-resistant subjects (platinum-free interval from the end of first-line treatment less than 6 months) &#8722; Platinum-sensitive subjects (platinum-free interval from the end of first-line treatment equal or more than 6 months) who are not expected to benefit from or who are ineligible for or who are not willing to receive retreatment with platinum-based chemotherapy Measurable or non-measurable disease that can be evaluated by response evaluation criteria in solid tumors (RECIST) for response and/or progression and documented by radiographic methods such as magnetic resonance imaging (MRI) or computed tomography (CT) scan. Date of radiological evidence is the documented date of progression For subjects with non-measurable disease, in addition to appropriate imaging, CA-125 level 2 X upper limit of normal (ULN) on at least 2 measurements more than 1 week apart, the second assessment during the screening phase of this study (performed by central lab) Must be able to receive dexamethasone or its equivalent Adequate organ function as evidenced by the following peripheral blood counts or serum chemistry values within 7 days prior to randomization: hemoglobin &#8805;9 g/dL absolute neutrophil count (ANC) &#8805;1,500/µL, and platelet count &#8805;100,000/µL serum creatinine &#8804;1.5 mg/dL (&#8804;132.6 µmol/L) or creatinine clearance &#8805; 60 mL/min CPK &#8804; ULN Hepatic function variables Total bilirubin &#8804; 1.5 ULN, direct bilirubin &#8804; ULN Total alkaline phosphatase &#8804; 1.5 ULN, or if > 1.5 ULN, then alkaline phosphatase liver fraction or 5’ nucleotidase must be &#8804; ULN AST and ALT must be &#8804; 2.5 x ULN Left ventricular ejection fraction (LVEF) by baseline MUGA scan or 2 d echocardiogram must be within normal limits for the institution (if required at baseline, see section 6.2.2) Adequately recovered from the acute toxicity of any prior treatment Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. At investigative sites that are participating in the optional CellSearch, pharmacogenomic, or protein testing portion of this protocol, the subject (or their legally acceptable representative) must sign the informed consent forms for CellSearch enumeration alone, or for additional pharmacogenomic testing, utilizing CellSearch, additional blood or paraffin samples or serum for DNA, mRNA, and protein expression analysis. These informed consent documents will indicate whether or not the subject wishes to participate in these parts of the study. Participation in the pharmacogenomics and CellSearch aspects of this study is not mandatory.
    E.4Principal exclusion criteria
    Exclusion Criteria* Potential subjects who meet any of the following criteria will be excluded from participating in the study: Subjects treated with more than 1 prior chemotherapy regimen (including adjuvant therapy) Refractory disease, defined as disease progression within six months of the beginning (first dose) of the initial line of platinum-based chemotherapy for ovarian cancer Isolated rise in CA-125 without documented radiological evidence of disease progression Prior exposure to anthracyclines for ovarian cancer or to YONDELIS or hypersensitivity to the pharmacologically active substance or to any of the excipients Subjects unwilling or unable to have a central venous catheter (which is required if randomized to treatment with YONDELIS + DOXIL combination arm) Subjects of child-bearing potential not employing adequate contraception which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to subjects that are surgically sterile) or subjects who are lactating. Less than 4 weeks from radiation therapy or last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or more Known hypersensitivity to doxorubicin or to excipients in the formulations of either DOXIL or YONDELIS. Known clinically relevant CNS metastasis Active viral hepatitis or history of liver disease Myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities. Any other unstable medical conditions, such as: &#8722; Uncontrolled diabetes &#8722; Psychiatric disorder (including dementias) that prevents compliance with protocol &#8722; Uncontrolled seizures &#8722; Acute deep vein thrombosis requiring intravenous or subcutaneous therapeutic anticoagulant therapy (chronic coumadin or prophylactic subcutaneous heparin allowed) &#8722; Active infection
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint, OS, is defined as the time between the date of randomization and the date of death. Subjects who die, regardless of the cause of death, will be considered to have had an event. Subjects who withdraw consent for the study will be censored at the time of withdrawal. Subjects who complete the study and are still alive at the time of the clinical data cut-off date will be censored. All subjects who were lost to follow-up prior to the clinical data cut-off date will also be censored at the time of last contact. OS will be compared between both treatment arms by the unstratified log rank test. Another key primary endpoint, PFS, is defined as the time between the date of randomization and the date of disease progression or death. This analysis will utilize the determination of progression date documented by central review (Section 11.4.5). Subjects who progressed or died will be considered to have had an event. Subjects who complete the study without disease progression will be censored at the last tumor assessment prior to end of the study. Subjects who are lost to follow-up without disease progression will be considered censored at the time of last tumor assessment. PFS will be compared between both treatment arms by the un-stratified logrank test.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Yondelis + Doxil/Caelyx vs Doxil/Caelyx
    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.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female 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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state61
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 308
    F.4.2.2In the whole clinical trial 650
    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 Decision2006-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-12
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