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    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2006-006626-26
    Sponsor's Protocol Code Number:OSI3364g
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-23
    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 - PEI
    A.2EudraCT number2006-006626-26
    A.3Full title of the trial
    A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination with Tarceva (erlotinib) Compared With Tarceva Alone For Treatment of Advanced Non−Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy
    A.4.1Sponsor's protocol code numberOSI3364g
    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 SponsorGenentech, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTarceva
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNerlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRo 50-8231 / OSI-774
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25, 100, 150
    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: 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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.1Product nameAvastin
    D.3.2Product code RO4876646
    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 INNBevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMAb-VEGF, anti VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 mg/4 mL to 400 mg/16 mL
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant Humanised Monoclonal Antibody
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderF. Hoffman-La Roche Inc
    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.3.1Product nameTarceva
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNerlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRo 50-8231 / OSI-774
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25, 100, 150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-small-cell-lung-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 10066490
    E.1.2Term Progression of non small cell lung cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this Phase III study was to evaluate the efficacy of combining bevacizumab with Tarceva (erlotinib) relative to Tarceva monotherapy in patients receiving second-line therapy for advanced NSCLC. Efficacy will be assessed by measuring overall survival.
    E.2.2Secondary objectives of the trial
    •Evaluate the safety of combining bevacizumab with Tarceva in patients with previously treated advanced NSCLC, including patients with squamous cell carcinoma, treated brain metastases, and patients receiving full-dose anticoagulation with low-molecular-weight heparin or fondaparinux.
    •Evaluate the efficacy of combining bevacizumab with Tarceva relative to Tarceva monotherapy in patients with previously treated advanced NSCLC, as measured by PFS, objective response rate, disease control rate and duration of response
    •Evaluate the pharmacokinetic behavior of Tarceva and the combination of bevacizumab with Tarceva in a subset of patients with previously treated advanced NSCLC
    •Evaluate the association of survival, PFS, and treatment effect with markers of EGFR expression, as measured by immunohistochemistry (IHC), EGFR gene copy number measured by fluorescence in situ hybridization (FISH) and other molecular markers of EGFR pathway activity in archival tissue samples
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The sub-study is included in the main protocol in Appendix C (page 126). At least 17 patients in each treatment arm from selected institutions will be consented to participate in the intensive pharmacokinetic analysis and will undergo extensive sampling according to the schedule outlined below. Patients at participating institutions must sign the Pharmacokinetic Sample Informed Consent Form to indicate whether or not they consent to participate in the optional pharmacokinetic sampling.
    E.3Principal inclusion criteria
    Patients are eligible for this second-line therapy study if they have recurrent or refractory (progression through at
    least two cycles of a given chemotherapeutic
    regimen) NSCLC following standard first-line chemotherapy or chemoradiotherapy.
    • Signed written informed consent
    • Cytologically or histologically confirmed NSCLC
    Patients had to have histologically or cytologically confirmed NSCLC. Tumors of mixed histology were
    categorized by the predominant cell type unless small cell elements were present, in which case the patient
    was not eligible for study participation. Cytologic or histologic elements have been established on metastatic
    tumor aspirates or biopsy. Patients with squamous cell carcinoma were eligible provided that their disease
    was extrathoracic or that their intrathoracic disease consists of peripheral lesions only. A peripheral lesion was
    defined as a lesion (or lesions) in which the epicenter of the tumor was ≤ 2 cm from the costal or diaphragmatic
    pleura in a 3-dimensional orientation based on each lobe of the lung, and > 2 cm from the trachea, main,
    and lobar bronchi. Squamous cell carcinoma patients were eligible for study participation irrespective of
    the proximity of their adenopathy to the costal or diaphragmatic pleura or major airways. Patients with hilar
    adenopathy were eligible for study participation. Patients with squamous cell carcinoma had to have a copy of
    the screening computed tomography (CT) or magnetic resonance imaging (MRI) scans (either as copy films or
    digital images) reviewed by Genentech or its designee prior to randomization. Patients were not randomized until
    Genentech or its designee confirmed eligibility. Patients with a history of brain metastases were eligible for study
    participation, as long as their brain metastases had been treated and they did not have an ongoing requirement
    for treatment with dexamethasone at screening. Treatment had to be with WBRT (e.g., 3000 cGy over 2 weeks)
    and might include neurosurgery, or stereotactic radiosurgery. Radiotherapy and stereotactic radiosurgery had to
    be completed at least 4 weeks prior to Day 0 (see Section 4.3.2). Neurosurgery had to be completed at least 24
    weeks prior to Day 0, and brain biopsy must be completed at least 12 weeks prior to Day 0.
    • Clinical or radiographic progression during or after first-line chemotherapy
    or chemoradiotherapy for NSCLC. Patients receiving neo-adjuvant and adjuvant therapy for Stage I–IIIa disease
    prior to their first-line regimen were eligible for study participation provided they had also received first-line
    therapy (for unresectable, metastatic disease) and had demonstrated progression during or after that first-line
    therapy.
    • Consent to provide archival tissue for analysis was required for participation in this study. Patients who
    consented to provide tissue but whose archival tissue was found to be inadequate (e.g., stained slides) remained
    eligible for study participation.
    • ECOG performance status of 0, 1, or 2.
    • Age ≥ 18 years
    • Use of an acceptable means of contraception for men and women of childbearing potential
    • INR no greater than 1.3 and an aPTT no greater than the upper limits of normal within 28 days prior to
    enrollment for patients not on low-molecular-weight heparin or fondaparinux. Patients on low-molecular-weight
    heparin or fondaparinux were not required to meet INR or aPTT limits.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria were ineligible for study entry:
    • Squamous cell carcinoma, except for patients with no intrathoracic disease or small peripheral lesions only.
    • Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent
    Angiogenesis inhibitors include (but are not limited to) bevacizumab, thalidomide, CP 547632, SU 11248, and
    PTK 787.
    • Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior to randomization. Local
    palliative radiotherapy within 14 days prior to randomization or persistent adverse effects from radiotherapy that
    have not resolved to Grade 2 or less following completion of treatment
    • Whole brain radiotherapy or stereotactic radiosurgery for brain metastases within 4 weeks of Day 0
    • Neurosurgery for brain metastases within 24 weeks of Day 0
    • Brain biopsy within 12 weeks of Day 0
    • Current use of dexamethasone for treatment associated with brain metastases
    • History of gross hemoptysis (defined as bright red blood of at least 1/2 teaspoon or 2.5 mL per episode) within 3
    months prior to randomization unless definitively treated with surgery or radiation
    • History of any of the following within 6 months prior to Day 0: serious systemic disease, including myocardial
    infarction, uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100
    mmHg taken per the JNC 7 guidelines, unstable angina, New York Heart Association (NYHA) Grade 2 or
    greater CHF, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia,
    i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), clinically significant peripheral
    vascular disease, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess. Patients with
    evidence of hypertension during study screening were to be evaluated for uncontrolled hypertension in
    accordance with the JNC 7 guidelines.
    • Evidence of bleeding diathesis or coagulopathy or other serious or acute internal bleeding within 6 months prior
    to randomization
    • CNS bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic) within the last 6 months
    • Progressive neurologic symptoms in patients with a history of brain metastases
    • Full-dose anticoagulation with warfarin. Patients who required full-dose anticoagulation could be treated with
    low-molecular-weight heparin or fondaparinux. Patients fully anticoagulated with warfarin during the study were
    discontinued from bevacizumab/placebo.
    • Chronic daily use of aspirin (> 325 mg/day) or other full-dose NSAIDs with anti-platelet activity. Treatment
    with other antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, and/or cilostazol) was permitted.
    • In-patient surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
    (placement of a central line is not considered surgery, and could be placed on the same day as study drug
    administration)
    • Minor surgical procedure, fine needle aspirations or core biopsy within 7 days prior to randomization
    • Anticipation of need for a major surgical procedure during the course of the study
    • Serious, non-healing wound, ulcer, or bone fracture
    • Inability to take oral medication or requirement for IV alimentation or total parenteral nutrition with lipids, or
    prior surgical procedures affecting absorption
    • Any of the following abnormal hematologic values (within 1 week prior to
    randomization: ANC ≤ 1000 cells/μL; Platelet count ≤ 100,000 cells/μL; Hemoglobin ≤ 9.0 g/dL; INR ≥ 1.5 ×
    upper limit of normal (ULN)
    • Any of the following abnormal liver function tests (within 1 week prior to randomization): Serum bilirubin ≥
    1.5 × ULN; Albumin ≤ 2.5 g/dL; Serum ALT ≥ 2 × ULN (unless clearly due to liver metastases, then 5 × ULN);
    Serum AST ≥ 2 × ULN (unless clearly due to liver metastases, then 5 × ULN)
    • Other baseline laboratory values: Uncontrolled hypercalcemia (≥ 11.5 mg/dL); Urinary protein/creatinine ratio ≥
    1 (spot urine); Serum creatinine ≥ 2.0 × ULN
    • Pregnancy or breast-feeding. Because of the possible teratogenic effect. All women of childbearing potential
    must have a negative pregnancy test within 1 week prior to randomization.
    • Presence of another invasive cancer within 5 years prior to randomization, except for adequately treated basal or
    squamous cell skin cancer, or carcinoma in situ of the cervix
    • Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient’s
    understanding of the Informed Consent Form or their ability to comply with study requirements
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint was overall survival, defined as the period from the date of randomization (as
    entered in the IVRS) until the date of patient death from any cause. All deaths were included, regardless of
    whether they occur during treatment or following treatment discontinuation. For patients who have not died,
    survival data were censored at the date of last contact.
    The two-sided log-rank test, stratified by the randomization stratification factors, was used to perform hypothesis
    testing for assessing the primary study objective. The randomization stratification factors were ECOG
    performance status (0/1 vs. 2), smoking history (never vs. current/previous), sex (male vs. female), and study
    site; however, because of the large number of study sites in this trial, study sites will not be included in any
    efficacy analyses adjusted for randomization stratification factors. Levels of the stratification factors reported
    on the CRF were used in the analysis. A sensitivity analysis stratified using levels reported on the IVRS was
    performed. Both analyses were based on the treatment arm to which the patients have been randomized.
    An interim efficacy analysis was conducted when approximately 67% of the required deaths (280 deaths)
    occurred. Overall survival was tested at the significance level determined using the Lan-DeMets alpha spending
    function with an
    O’Brien-Fleming boundary so that the overall type I error rate will be maintained at
    the 0.05 level.
    The unstratified log-rank test was performed as a sensitivity analysis. The Kaplan-Meier methods were used to
    estimate median overall survival for each treatment arm. Cox proportional hazard models, using two models
    (with and without stratification by the randomization stratification factors), were employed to estimate the hazard
    ratio (i.e., the magnitude of treatment effect and 95% CI).
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 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 EEA33
    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 Yes
    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 years1
    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 years1
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-02-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    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 Decision2007-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-31
    P. End of Trial
    P.End of Trial StatusCompleted
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