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    Summary
    EudraCT Number:2012-004112-63
    Sponsor's Protocol Code Number:DutchSTRIDER
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-07-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-004112-63
    A.3Full title of the trial
    The Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset intrauterine growth Restriction) Trial
    The Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset intrauterine growth Restriction) Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sildenafil for early severe fetal growth restriction
    Sildenafil voor vroege ernstige foetale groeivertraging
    A.3.2Name or abbreviated title of the trial where available
    Dutch STRIDER
    STRIDER
    A.4.1Sponsor's protocol code numberDutchSTRIDER
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    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 supportZonMw
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointObs/gyn Consortium
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31205663857
    B.5.6E-mailinfo@studies-obsgyn.nl
    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 Viagra
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboTablet
    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
    Fetal growth restriction
    foetale groeivertraging
    E.1.1.1Medical condition in easily understood language
    Fetal growth restriction
    foetale groeivertraging
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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
    We aim to evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy perinatal survival, in women with singleton pregnancies with severe fetal growth restriction of placental origin.
    We willen de effectiviteit onderzoeken van sildenafil om gezonde perinatale overleving te bereiken bij vrouwen met een eenlingzwangerschap met ernstige foetale groeivertraging met placentaire oorzaak.
    E.2.2Secondary objectives of the trial
    The secondary objectives of study are
    1) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of improved fetal growth velocity assessed by ultrasound abdominal circumference measurements (AC);
    2) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score);
    3) to assess co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome
    De secundaire doelstellingen van de studie zijn te onderzoeken of Sildenafil citraat tov placebo
    1) de foetale groeisnelheid doet toenemen, beoordeeld door echoscopische buikomtrek metingen
    2) de ontwikkeling op 2 jaar doet verbeteren, beoordeeld door Bailey testen.
    3) de incidentie van maternale hypertensieve syndromen verbetert
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria ((I OR II) AND III):
    I. at 200-276 weeks: an ultrasound measurement of the fetal abdominal circumference (AC) <3rd percentile for gestational age or an ultrasound estimate of fetal weight (EFW) <5th percentile
    OR
    II. at 280-296 weeks: an ultrasound estimate of fetal weight (EFW) <700 grams
    AND
    III. likely placental origin defined by (a AND/OR b AND/OR c AND/OR d)
    a. the presence of uterine artery notching
    b. abnormal flow velocity patterns of the umbilical artery or middle cerebral artery
    c. maternal hypertensive disorders
    d. low PlGF in point-of-care assessment
    Inclusion criteria ((I OR II) AND III):
    I. at 200-276 weeks: an ultrasound measurement of the fetal abdominal circumference (AC) <3rd percentile for gestational age or an ultrasound estimate of fetal weight (EFW) <5th percentile
    OR
    II. at 280-296 weeks: an ultrasound estimate of fetal weight (EFW) <700 grams
    AND
    III. likely placental origin defined by (a AND/OR b AND/OR c AND/OR d)
    a. the presence of uterine artery notching
    b. abnormal flow velocity patterns of the umbilical artery or middle cerebral artery
    c. maternal hypertensive disorders
    d. low PlGF in point-of-care assessment
    E.4Principal exclusion criteria
    Exclusion criteria:
    I. Plan to terminate pregnancy for maternal or fetal indication within days
    II. Known multiple pregnancy
    III. identified congenital anomalies or congenital infection
    IV. Maternal age at eligibility <18 years
    Exclusion criteria:
    I. Plan to terminate pregnancy for maternal or fetal indication within days
    II. Known multiple pregnancy
    III. identified congenital anomalies or congenital infection
    IV. Maternal age at eligibility <18 years
    E.5 End points
    E.5.1Primary end point(s)
    The Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) Trial is a double-blind randomised controlled trial (RCT) designed to evaluate whether in pregnant women with severe early-onset FGR of placental origin, Sildenafil citrate compared with placebo increases the likelihood of intact perinatal survival until term age. This is defined by the survival to term age without evidence of either severe central nervous system (CNS) injury (by ultrasound and/or magnetic resonance imaging [MRI]) or non-CNS severe morbidity (bronchopulmonary dysplasia, retinopathy of prematurity, or necrotising enterocolitis requiring surgery).

    The Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) Trial is a double-blind randomised controlled trial (RCT) designed to evaluate whether in pregnant women with severe early-onset FGR of placental origin, Sildenafil citrate compared with placebo increases the likelihood of intact perinatal survival until term age. This is defined by the survival to term age without evidence of either severe central nervous system (CNS) injury (by ultrasound and/or magnetic resonance imaging [MRI]) or non-CNS severe morbidity (bronchopulmonary dysplasia, retinopathy of prematurity, or necrotising enterocolitis requiring surgery).

    E.5.1.1Timepoint(s) of evaluation of this end point
    Term age
    Uitgerekende datum
    E.5.2Secondary end point(s)
    The secondary objectives of study are
    1) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of improved fetal growth velocity assessed by ultrasound abdominal circumference measurements (AC);
    2) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score);
    3) to assess co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome

    Announced subgroup analyses:
    to evaluate the effect of Sildenafil on the abovementioned outcome measures, in subgroups defined by a) an abnormal or normal serum level of placental growth factor (PlGF); b) absent/reversed umbilical arterial end diastolic flow (REDF) at commencement of treatment; c) other patient characteristics available at baseline such as gestational age, estimated fetal weight;
    The secondary objectives of study are
    1) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of improved fetal growth velocity assessed by ultrasound abdominal circumference measurements (AC);
    2) to evaluate whether Sildenafil citrate, compared to placebo, increases the likelihood of age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score);
    3) to assess co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome

    Announced subgroup analyses:
    to evaluate the effect of Sildenafil on the abovementioned outcome measures, in subgroups defined by a) an abnormal or normal serum level of placental growth factor (PlGF); b) absent/reversed umbilical arterial end diastolic flow (REDF) at commencement of treatment; c) other patient characteristics available at baseline such as gestational age, estimated fetal weight;
    E.5.2.1Timepoint(s) of evaluation of this end point
    Term age and 2 years
    Uitgerekende datum en 2 jaar
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned10
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    LVLS
    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 days0
    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.1.2.1Number of subjects for this age range: 354
    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 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 No
    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 state354
    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)
    None
    Geen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Dutch Obs/Gyn Consortium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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