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    Summary
    EudraCT Number:2006-002235-25
    Sponsor's Protocol Code Number:A1481131
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-13
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-002235-25
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA1481131
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorPfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom
    B.1.3.4CountryUnited Kingdom
    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/3/03/178
    D.3 Description of the IMP
    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 INNsildenafil (as citrate)
    D.3.9.1CAS number N/A
    D.3.9.3Other descriptive nameUK-92,480
    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 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 Revatio
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/03/178
    D.3 Description of the IMP
    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 INNsildenafil (as citrate)
    D.3.9.1CAS number N/A
    D.3.9.3Other descriptive nameUK-92,480
    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 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 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/3/03/178
    D.3 Description of the IMP
    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 INNsildenafil (as citrate)
    D.3.9.1CAS number N/A
    D.3.9.3Other descriptive nameUK-92,480
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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: 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/3/03/178
    D.3 Description of the IMP
    D.3.1Product nameSildenafil Citrate
    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 INNsildenafil (as citrate)
    D.3.9.1CAS number N/A
    D.3.9.3Other descriptive nameUK-92,480
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary Arterial Hypertension
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.0
    E.1.2Level LLT
    E.1.2Classification code 10064911
    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 this study is to assess the efficacy of 16 weeks of chronic treatment with oral sildenafil in pediatric subjects, aged 1 to 17 years, with PAH. Primary efficacy will be measured by exercise tolerance, bicycle ergometry testing in those subjects who are developmentally able to perform the exercise paradigm as described in Section 3.3.2 and Appendix E of the protocol. Secondary efficacy will be assessed in all subjects as described in Section 6.4.1.2. of the protocol.
    E.2.2Secondary objectives of the trial
    - To assess safety, tolerability, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil in pediatric subjects, aged 1 to 17 years with PAH.

    - To assess the survival status of subjects who have discontinued study drug
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subjects aged from 1 to 17 years old. Females of child bearing potential who are sexually active must be practicing a suitable method of birth control so that in the opinion of the investigator, they will not become pregnant during the study;
    - Subjects weighing ≥8 kg;
    - Subjects who have symptomatic pulmonary arterial hypertension due to one of the
    following conditions:
    • Primary pulmonary hypertension;
    • Pulmonary arterial hypertension in the presence of a small or hemodynamically insignificant congenital systemic to pulmonary shunt lesion that in the opinion of the investigator is not the cause of pulmonary hypertension;
    • Pulmonary arterial hypertension associated with collagen vascular disease (e.g.,
    scleroderma);
    • Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts with a baseline resting room air oxygen saturation ≥88%. If the defect(s) is repaired, it should have been repaired at least 6 months prior to screening. Note: Repairs can be either surgical or via interventional cardiac catheterization (eg, ASD closure device or coil of PDA);
    • Pulmonary arterial hypertension associated with d-transposition of the great arteries repaired within the first 30 days of life; or Pulmonary arterial hypertension in subjects who have undergone surgical repair of other congenital heart lesions at least 6 months prior to screening and do not have clinically significant residual left-sided heart disease consistent with the exclusion criteria.
    - Subjects with a mean pulmonary artery pressure ≥25 mmHg at rest, PCWP
    ≤15 mmHg, and PVRI ≥3 Wood units x m2. If PCWP is not available, then mean
    LA pressure ≤15 mmHg or LVEDP ≤15 mmHg in the absence of left atrial
    obstruction;
    Note: Hemodynamic measurements can be performed within 21 days prior to randomization for study purposes. These criteria must be within specified baseline limits for subject to qualify for randomization. Hemodynamic measurements from the retrospective right heart catheterization may be used for qualification provided the subject’s background therapy (class of drug) for PAH did not change for the 10 days prior to the procedure, and has not changed since the procedure was performed.
    - Subjects, developmentally able to exercise, whose CPX exercise test functional
    capacity is within the following parameters: Peak VO2 ≥10 mL/kg/min and
    ≤28 mL/kg/min during screening CPX test;
    - The investigator must obtain written informed consent and assent where applicable
    before the subject is screened for the study. The inclusion of a subject more than once in the same clinical trial is not permissible; and
    - Subjects who undergo a large shift in altitude in order to participate in the study (e.g., live at altitude and shift to sea level in order to participate) must reside at the “in study” altitude for at least 90 days prior to baseline and during the study period.
    Note: A “large shift is being defined as approximately 5000 feet or 1524 meters.
    E.4Principal exclusion criteria
    All exclusion criteria must be adhered to. Subjects with any of following conditions cannot be enrolled into the study.
    - Subjects with pulmonary hypertension secondary to sickle cell disease, any other
    disease known to be associated with PAH, or any etiology other than those specified in the inclusion criteria;
    - Left-sided heart disease, including any of the following:
    • Aortic or mitral valve disease (greater than mild);
    • Restrictive or congestive cardiomyopathy;
    • PCWP or LVEDP > 15mmHg;
    • LVEF <40% determined by MUGA, angiography or echocardiography;
    • LV shortening fraction <22% determined by echocardiography;
    • Symptomatic coronary disease (demonstrable ischemia)
    - Pericardial constriction;
    - Subjects with significant (2+ for regurgitation) valvular disease other than tricuspid or pulmonary regurgitation;
    - Acutely decompensated heart failure within previous 30 days from screening;
    - Subjects who have had an atrial septostomy within previous 6 months of screening;
    - Subjects with hemodynamic instability or hypo- or hypertension at screening, i.e., SBP outside of 70-140 mmHg;
    - Subjects with a history of stroke, myocardial infarction or life threatening arrhythmia
    within 6 months of screening;
    - Subjects with moderate to severe restrictive pulmonary disease (Total Lung Capacity or Forced Vital Capacity ≤60% of normal) or history of severe lung disease;
    - Subjects with bronchopulmonary dysplasia (BPD) and other chronic lung diseases;
    - Subjects with history of pulmonary embolism;
    - Subjects whose CPX test is limited by conditions other than pulmonary hypertensionassociated dyspnea or fatigue;
    - Subjects with known hereditary degenerative retinal disorders such as retinitis
    pigmentosa;
    - Subjects who are known to be HIV positive;
    - Subjects with impairment of renal function (serum creatinine >2.5 × ULN ) or hepatic
    function (ALT and/or AST >3 × ULN; and/or bilirubin ≥2 mg/dL). Hematological
    abnormalities (e.g., severe anemia, Hgb <10 g/dL, leukopenia, WBC <2500/µL);
    - Subjects who previously received bosentan and whose liver function tests taken at
    screening are >2 × ULN;
    - Subjects with any medical condition which in the opinion of the investigator may
    interfere with treatment, evaluation of safety, and/or efficacy. Abnormalities of
    questionable clinical significance must be discussed with a Pfizer clinician prior to
    inclusion of the subject;
    - Change in class of medication for CHF or PAH within the 10 days prior to qualifying
    right heart catheterization. (Note: Discontinuation of coumadin, start of heparin, and
    the re-starting of coumadin for cardiac catheterization is not considered change in dose or class.);
    - Subjects who are currently prescribed and/or taking nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or aerosols). Acute
    vasodilator testing with nitric oxide is permitted during hemodynamic evaluation;
    - Subjects taking chronic arginine supplementation including Heart Bar;
    - Subjects who within 3 months of screening have had therapy involving parenteral
    inotropic medication (e.g., dobutamine or milrinone) or parenteral vasodilators (e.g..
    nitroprusside);
    - Subjects on alpha-blockers or potent cytochrome P450 3A4 inhibitors (e.g.,
    erythromycin, ketoconazole, itraconazole and protease inhibitors);
    - Subjects who are currently receiving Ritonavir or Nicorandil;
    Subjects receiving chronic treatment with off-label sildenafil are excluded. Subjects
    receiving an endothelin antagonist (e.g., bosentan) or, prostacyclin/prostacyclin
    analogue within 30 days of randomization are excluded. Use of prostacyclin for acute
    vasodilator testing during cardiac catheterization is allowed;
    - Pregnant or lactating female;
    - Subjects who have any medical or psychological condition or social circumstances that would impair their ability to participate reliably in the study or who may increase the risk to themselves or others by participating;
    - Current or past illicit drug use or alcoholism excepting if abstinence can be
    documented for ≥1 year;
    - Participation in another clinical trial of an investigational drug or device (including
    placebo) within 30 days of screening for entry into the present study; or
    Note: If a subject has previously taken part in Study A1481134 or A1481157 at least 30 days prior to screening of this study and fulfills all inclusion criteria may be considered for entry into this study.
    - In the opinion of the investigator, a subject who is not likely to complete the study for any reason.
    - Subjects with known hereditary degenerative retinal disorders (such as retinitis
    pigmentosa) or history of non-arteritic anterior ischemic optic neuropathy (NAION).
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in peak VO2 normalized to body weight from baseline to Week 16 assessed by CPX testing (bicycle ergometry). As described previously, this endpoint will be evaluated in those subjects who are developmentally able to perform the CPX 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 EEA25
    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 years4
    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 years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The study subjects are between 1-17 years of age. A person with parental responsibility or a legal representative must give informed consent and may withdraw the young person at any time.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 204
    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 Decision2007-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
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