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    Summary
    EudraCT Number:2005-001895-11
    Sponsor's Protocol Code Number:AI424-138
    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:2005-11-25
    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 number2005-001895-11
    A.3Full title of the trial
    A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavir with Lopinavir/ritonavir, Each in Combination with Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment Naive Subjects.

    Revised Protocol 04 Incorporating changes from Amendment 03, 04, 05, 06 (Version 1.0, Date 03-Apr-2007), and Administrative Letter dated 31-Oct-2006. Pharmacogenetics Blood Sample Amendment 01, version 1.0, dated 21-Sep-05; and Metabolic Pharmacogenetics Substudy Amendment 02, version 1.0, dated 21-Sep-05
    A.4.1Sponsor's protocol code numberAI424-138
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 Yes
    D.2.1.1.1Trade name Reyataz
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Company
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameReyataz
    D.3.2Product code BMS-232632
    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 INNatazanavir
    D.3.9.1CAS number 229975-97-7
    D.3.9.2Current sponsor codeBMS-232632
    D.3.9.3Other descriptive nameATV
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Norvir
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories 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 nameNorvir
    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 INNRitonavir
    D.3.9.1CAS number 155213-67-5
    D.3.9.3Other descriptive nameRTV
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 Kaletra
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories 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 nameKaletra
    D.3.4Pharmaceutical form Capsule, soft
    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 INNLopinavir
    D.3.9.3Other descriptive nameLPV
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number133.3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRitonavir
    D.3.9.3Other descriptive nameRTV
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33.3
    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 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 Truvada
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameTruvada
    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 INNEmtricitabine
    D.3.9.3Other descriptive nameFTC
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTenofovir disoproxil fumarate
    D.3.9.3Other descriptive nameTDF
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    HIV-1 Infected Treatment Naive Subjects
    MedDRA Classification
    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 the study is to compare the proportion of subjects with HIV
    RNA < 50 c/mL at Week 48 between the ATV/RTV/TDF/FTC and LPV/RTV/TDF/FTC treatment regimens.
    E.2.2Secondary objectives of the trial
    To assess:
    -proportion of subjects with HIV RNA<400 c/mL at Week 48
    -proportions of subjects with HIV RNA<50 c/mL and <400 c/mL at Week 96
    -time to loss of virologic response
    -reduction of log10 HIV RNA from baseline through Weeks 48 and 96
    -change in CD4 cell count from baseline through Weeks 48 and 96
    -safety and tolerability of the regimens
    -changes from baseline in fasting lipids over time and proportion of subjects with NCEP-guided categories of fasting lipids over time
    -changes from baseline in fasting glucose and insulin
    -antiretroviral resistance profiles of subjects experiencing virologic failure
    -trough concentrations of ATV, LPV, and RTV and to explore correlations
    with efficacy and safety parameters

    To evaluate:
    -quality of life (as by MOS-HIV)
    -impact of gastro-intestinal toxicity on the quality of life (as by IBS-QOL questionnaire)
    -adherence to each drug and to the regimen (as by MACS adherence questionnaire)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    * LIPODYSTROPHY SUBSTUDY (Appendix 1 to Protocol v4.0, Dated 09-Oct-2006)

    Primary objective:
    To compare the changes in body fat redistribution, as assessed by the change from baseline in trunk-to-limb fat ratio measured by DEXA at Week 96.

    Secondary objectives:
    1) To assess the change in body fat redistribution using the change from baseline in trunk-to-limb fat ratio measured by DEXA at Week 48;
    2) To assess the changes from baseline in limb, trunk and total body fat measured by DEXA at Weeks 48 and 96;
    3) To assess the changes from baseline in VAT, SAT and total adipose tissue (TAT) measured by CT at Weeks 48 and 96;
    4) To assess the changes from baseline in spinal and hip bone mineral density measured by DEXA at Weeks 48 and 96;
    5) To evaluate changes from baseline in physical measurements at Weeks 48 & 96; 6) To evaluate changes from baseline in exploratory markers including adipocytokines, hormones and inflammatory proteins including adiponectin, leptin, resistin, TNF-alpha, IL-6, PAI-1, Hs-CRP, HbA1c and fibrinogen over time.


    * INTENSIVE PHARMACOKINETIC SUBSTUDY (Appendix 1 to Protocol v4.0, Dated 09-Oct-2006)

    Objectives: The following objectives will be evaluated at Week 4:
    • To assess the steady state pharmacokinetics of ATV/RTV in ARV naïve HIV-infected subjects in the presence of an ARV regimen including TDF.
    • To assess the steady state pharmacokinetics of LPV/RTV in ARV naïve HIV-infected subjects in the presence of an ARV regimen including TDF.
    • To assess the differential effect of ATV/RTV and LPV/RTV on the pharmacokinetics of tenofovir.
    • To compare inhibitory quotient (IQ) of ATV and LPV (when dosed with RTV) using the concentration at the end of the dosing interval relative to the protein binding-corrected HIV EC90 values for the respective protease inhibitor derived from individual subject clinical isolates collected at baseline.


    * METABOLIC PHARMACOGENETIC SUBSTUDY (Protocol Amendment 2, v1.0, Dated 21-Sep-2005):

    To explore the relationship between the changes from baseline at Weeks 48 and 96 in fasting lipid profiles, insulin resistance, fat redistribution, and atherogenic and inflammatory markers associated with variant alleles of APOC3, APOE, TNF╬▒ in HIV-infected individuals treated with ATV/RTV or LPV/RTV, both in combination with TDF/FTC.
    E.3Principal inclusion criteria
    1) Provide written informed consent and assess whether the subject is capable of reading and comprehending the informed consent;
    2) Qualifying plasma HIV RNA ≥ 5000 c/mL obtained at screening;
    3) Men and women, ages 18 years and older (or minimum age as determined by local regulatory or as legal requirements dictate).
    4) Women of childbearing potential (WOCBP) must be using an adequate method of
    contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized. Both females and males must utilize effective barrier contraception.
    E.4Principal exclusion criteria
    1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study;
    2) WOCBP using a prohibited contraceptive method (see Protocol Appendix 8);
    3) Women who are pregnant or breastfeeding;
    4) Women with a positive pregnancy test on enrollment or prior to study drug administration;
    5) Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment;
    6) Suspected primary (acute) HIV infection;
    7) Any antiretroviral therapy within 30 days prior to screening
    8) Prior antiretroviral therapy ≥ 1 week.
    However in specific settings of antiretroviral treatment including
    a/ post exposure prophylaxis (PEP)
    b/ pre-exposure prophylaxis (PREP) and/or
    c/ HAART exposure for reduction of risk of mother-to-child transmission,
    the following prior antiretroviral exposure exceptions will apply, allowing the subject entry into the study:
    •< 6 weeks of triple antiretroviral therapy (3 drugs of any class)
    or
    •< 4 weeks of dual antiretroviral therapy (2 drugs of any class)
    or
    •<1 week of mono-antiretroviral therapy (1 drug of any class)
    9) Subjects with Cushing’s syndrome;
    10) Untreated hypothyroidism or hyperthyroidism;
    11) Recent therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment; or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4 (see Protocol Section 6.4 and Appendix 8);
    12) Subjects with obstructive liver disease;
    13) Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis;
    14) Proven or suspected acute hepatitis in the 30 days prior to study entry;
    Note: Chronic co-infection with hepatitis C and/or B are not exclusion criteria.
    Subjects with acute hepatitis infection may have the option to be screened after the
    event has evolved into a chronic infection.
    HBV co-infected subjects participating in this trial; and interrupting study therapy are
    at an increased risk of developing elevations in hepatic transaminases due to prior
    reports of exacerbations of hepatitis in patients after the discontinuation of
    TDF/FTC.15 Subjects with HBV co-infection are required to have an additional
    6 months of follow-up after stopping study medications.

    15) Intractable diarrhea (≥ 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry;
    16) Inability to swallow capsules;
    17) Active peripheral neuropathy;
    18) Presence of cardiomyopathy or any significant cardiovascular disease;
    19) Known, clinically significant cardiac conduction system disease. This includes severe first degree atrioventricular block (PR interval > 0.26 seconds) as well as second and third-degree atrioventricular block;
    20) Moderate to Severe hepatic insufficiency
    • If hepatic insufficiency is demonstrated at screening then the subject will have the
    Child-Pugh Score calculated.
    • Subject will not meet eligibility if the screening Child-Pugh Score = > 6 (Classes B or
    C) (Appendix 13);
    21) Screening laboratory values measured as follows;:
    a) Calculated creatinine clearance < 60 mL/min as estimated by the Cockcroft-Gault equation:
    For men, (140 – age in years) x (body weight in kg) ÷ (serum
    creatinine in mg/dL x 72) = CrCl (mL/min)
    For women, multiply the result by 0.85
    b) total serum lipase ≥ 1.4 times the upper limit of normal,
    c) liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal,
    d) total serum bilirubin ≥ 1.5 times the upper limit of normal.
    22) Hypersensitivity to any component of the formulation of study drug;
    23) Prohibited therapies and/or medication (see Protocol Appendix 8);
    24) Subjects who have conditions that would lead the investigator to believe that there is
    a significant likelihood that the subject will need prohibited therapies or medications
    (e.g. Proton Pump Inhibitors) while on study therapy;
    25) Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements;
    26) Prisoners or subjects who are compulsorily detained.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with HIV RNA < 50 c/mL at Week 48.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Outcomes Research Assessments (QoL); Tolerability of the regimens
    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) 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) Yes
    E.8.2.2Placebo No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    LPLV
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero 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.1.3Elderly (>=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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 297
    F.4.2.2In the whole clinical trial 1200
    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 Decision2005-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-28
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