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    Summary
    EudraCT Number:2004-003793-29
    Sponsor's Protocol Code Number:INTAPP - 087700 (health Canada)
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-12-20
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2004-003793-29
    A.3Full title of the trial
    INternational Trial

    of Antioxidants for the Prevention of Preeclampsia

    (INTAPP)
    A.3.2Name or abbreviated title of the trial where available
    INTAPP
    A.4.1Sponsor's protocol code numberINTAPP - 087700 (health Canada)
    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 SponsorSte-Justine Hospital - Montréal in the name of Canadian Institute of Health Research (Canada)
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Information not present in EudraCT
    D.2.1.1.1Trade name E-GEMS with C
    D.2.1.1.2Name of the Marketing Authorisation holderJR Carlson Laboratories, Inc, USA
    D.2.1.2Country which granted the Marketing AuthorisationCanada
    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 nameE-GEMS with C
    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.3.11 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 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 Yes
    D.3.11.13.1Other medicinal product typedietary supplement
    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 placeboCapsule, soft
    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
    Gestational (pregnancy induced) hypertension with or without significant proteinuria
    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
    To demonstrate that Vitamin C and Vitamin E daily supplementation reduces the incidence of gestational hypertension (with or without proteinuria) and its adverse condition(s) .
    E.2.2Secondary objectives of the trial
    1. To demonstrate that Vitamin C and Vitamin E daily supplementation reduces the incidence of pre-eclampsia.
    2. To demonstrate that Vitamin C and Vitamin E daily supplementation reduces the incidence of the following maternal and neonatal outcomes :
    Maternal Outcomes: maternal death, severe preeclampsia (severe gestational hypertension plus proteinuria), preterm delivery before 37 weeks of pregnancy (gestational age corrected by early ultrasound scan), premature rupture of membranes antenatal inpatient days.
    Neonatal Outcomes: intrauterine growth restriction (IUGR); < 3rd centile, perinatal mortality, spontaneous abortion, neonatal morbidity indicators, retinopathy of prematurity, leukomalacia, thrombocytopenia, neutropenia, early onset sepsis, necrotising enterocolitis, intraventricular haemorrhage, ventilation, need for O2 at 28 days, length of stay in Neonatal Intensive Care Unit.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Women with age of majority who are between 12 and 18 completed weeks of pregnancy would be assigned to one of two strata (See Table I). Gestational age of patients will be based on the last menstrual period and confirmed by early ultrasound examination.

    Table 1 : INTAPP Risk Strata Participants
    Strata I Low Risk Stratum Women who are having their first baby.
    Strata II High Risk Stratum Women who are having their first or second (or more) baby with pre-pregnancy chronic hypertension (or diastolic blood pressure 90 mmHg before 20 gestational weeks or use of antihypertensive medication), or pre-pregnancy diabetes (insulin-dependent or hypoglycemic agents), or multiple pregnancy, or women with a history of preeclampsia in the previous pregnancy.
    E.4Principal exclusion criteria
    a. Women who regularly consume supplements greater than 200 mg/day for vitamin C and/or 50 IU/day for vitamin E.
    b. Women who take warfarin (because of theoretical potentiation of warfarin by vitamin E).
    c. Women who have known foetal abnormalities (e.g. hydatidiform mole), or known fetal chromosomal or major malformations in the current pregnancy.
    d. Women who have a history of medical complications including:
    •endocrine disease such as thyroid disease
    •renal disease with altered renal function
    •epilepsy
    •any collagen disease such as lupus erythromatosus and scleroderma
    •active and chronic liver disease (hepatitis)
    •heart disease
    •serious pulmonary disease
    •cancer
    •haematologic disorder (patient with anaemia or thrombophylias will be included)
    e. Women with repeated spontaneous abortion. .Woman with a previous bleeding in the first trimester, can be included if the site documents a viable fetus at the time of recruitment.
    f. Women using illicit drug or alcohol regular use of during current pregnancy. Smokers are eligible. We will capture the number of cigarettes per day the patient smokes. In addition, information on the exposition to second-hand smoking will be also captured.
    E.5 End points
    E.5.1Primary end point(s)
    Gestational hypertension (with or without proteinuria) and its adverse condition(s).
    The adverse conditions must include :
    Diastolic pressure > 110 mmHg or systolic pressure > 160 mmHg;
    Proteinuria > 300 mg/ 24 hours urine collection;
    Convulsion (eclampsia);
    Thrombocytopenia;
    Elevated liver enzyme levels;
    Creatinine > 180 µmol/L;
    Hematocrit < 24 and blood transfusion;
    Intrauterine growth restriction <3rd centile;
    Perinatal death.
    Gestational hypertension with adverse conditions occurring during labour and postpartum will be included.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    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
    Last visit of the last patient (immediate post-partum of the last patient).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years4
    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 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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 Yes
    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 state3000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 12500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    non applicable
    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 Decision2005-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
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