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    Summary
    EudraCT Number:2012-005330-10
    Sponsor's Protocol Code Number:987654321
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-03-13
    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 number2012-005330-10
    A.3Full title of the trial
    Maternal pharmacokinetics and pharmacodynamics of nicardipine (iv) during treatment of severe hypertension in pregnancy.
    Maternale pharmacokinetiek en pharmacodynamiek van intraveneus nicardipine bij de behandeling van ernstige hypertensie in de zwangerschap.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    What is the effect of nicardipine on the pregnant woman with severe hypertension and how is nicardipine excreted?
    Wat is het effect van nicardipine op de zwangere vrouw met ernstige hoge bloeddruk en hoe wordt nicardipine uitgescheiden?
    A.4.1Sponsor's protocol code number987654321
    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 SponsorErasmus University Medical Centre
    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 supportnone
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus University Medical Centre
    B.5.2Functional name of contact pointS.W.A. Nij Bijvank
    B.5.3 Address:
    B.5.3.1Street AddressDr Molewaterplein 60
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GJ
    B.5.3.4CountryNetherlands
    B.5.6E-mails.w.a.nijbijvank@isala.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 Cardene IV
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas
    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.3.1Product namenicardipine
    D.3.2Product code RVG 14835
    D.3.4Pharmaceutical form Concentrate and diluent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pregnant patients with preeclampsia (hypertension and protein/creatinine ratio ≥ 30mg/mmol or ≥ 300mg protein/24hours) complicated with severe hypertension (systolic bloodpressure ≥ 160mmHg and/or diastolic blood pressure ≥ 110mmHg). Gestational age ≥ 20 weeks
    Zwangere patienten met preeclampsie (hoge bloeddruk en eiwit/kreatinine ratio ≥ 30mg/mmol of ≥ 300mg eiwit/24uur) gecompliceerd door ernstige hoge bloeddruk (systole ≥ 160mmHg en/of diastole ≥ 110mmHg. Zwangerschapsduur ≥ 20 weken
    E.1.1.1Medical condition in easily understood language
    Pregnant patients with high blood pressure and kidney damage complicated with severe hypertension with an gestational age ≥ 20 weeks
    Zwangere Patienten met zwangerschapsvergiftiging met als complicatie ernstige hoge bloeddruk. De zwangerschapsduur is meer dan 20 weken.
    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
    Our aim is to determine a Pharmacokinetic/Pharmacodynamic (PkPd) based dosing model for nicardipine used for treatment of severe hypertension in preeclamptic patients. The model is based upon determination of maternal, fetal and neonatal plasma levels of nicardipine, and the corresponding changes in maternal haemodynamic parameters after administration of nicardipine.
    Het doel van deze studie is het ontwikkelen van een doserings schema gebaseerd op pharmacokinetisch/pharmacodynamisch (PkPd) parameters. Het model is gebaseerd op bepalen van maternale, foetale en neonatale plasma spiegels van nicardipine, gecombineerd met de veranderingen in haemodynamische parameters na toediening van nicardipine.
    E.2.2Secondary objectives of the trial
    not applicable
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pregnant patients with preeclampsia (hypertension and protein/creatinine ratio ≥ 30mg/mmol or ≥ 300mg protein/24hours) complicated with severe hypertension (systolic bloodpressure ≥ 160mmHg and/or diastolic blood pressure ≥ 110mmHg)

    gestational age ≥ 20 weeks

    working knowledge of Dutch language
    Zwangere patienten met preeclampsie (hoge bloeddruk en eiwit/kreatinine ratio ≥ 30mg/mmol of ≥ 300mg eiwit/24uur) gecompliceerd door ernstige hoge bloeddruk (systole ≥ 160mmHg en/of diastole ≥ 110mmHg.

    Zwangerschapsduur ≥ 20 weken

    Goede kennis Nederlandse taal
    E.4Principal exclusion criteria
    Fetal indication for immediate delivery, ie. signs of fetal distress: spontaneous repeated persistent unprovoked decelerations on CTG

    Fetal death or major fetal congenital anomalies or estimated fetal weight below 500 grams

    Placental abruption

    Concomitant medication: nifedipine, cimetidine, labetalol

    Clinically relevant pulmonary edema, defined as clinically relevant respiratory failure or severe respiratory distress requiring oxygen supplementation (more than 10 litres), with rales and/or pulse oximetry of <94% on room air

    Eclampsia

    Suspicion of (sub)capsular liverhematoma on physical examination

    Renal failure (creatinine clearance < 40 mL/min)
    • Suspicion of cerebro-vascular incident on physical examination
    • Suspicion of trombo-embolism on physical examination
    • Other severe maternal complications
    • Maternal age <16 years
    • Mentally incapacitated patient
    • Impossible to place an intra-arterial catheter.
    Foetale nood

    Foetale sterfte of ernstige foetale afwijking of geschat foetaal gewicht < 500gr

    Solutio placentae

    Tegelijkertijd gebruik van: nifedipine, cimetidine, labetalol

    Longoedeem

    Eclampsie

    Overige ernstige maternale complicatie
    E.5 End points
    E.5.1Primary end point(s)
    Maternal first half life (1st 24 hours after initiation), second half life (24hours after administration), distribution half time, elimination half time, assessing risk of accumulation. Changes in blood pressure, heart rate, cardiac output, cardiac index, stroke volume, peripheral resistance, and NT-proBNP values after administration of nicardipine.
    Maternale 1e halfwaarde tijd ( 1e 24 uur na starten van de therapie), 2e halfwaarde tijd (na 24uur na starten therapie), distributie halfwaarde tijd, eliminatie halfwaarde tijd, schatting risico op accumulatie. Veranderingen in bloeddruk, hartslag, cardiac output, slagvolume, perifere vaatweerstand en bepalen NT-proBNP waarde na toediening van nicardipine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A blank blood sample will be obtained before the start of nicardipine infusion and just before each dosage change. After initiation of nicardipine therapy and following each dosage change 1 ml blood will be drawn at 15 min, 30 min, 1 hour and 2 hours.
    After target blood pressure is reached 1mL blood will be withdrawn every 6 hours from the arterial catheter until 48 hours after each dosage adjustment or until the end of infusion.One mL blood will be sampled 1, 2, 4, 8, 12, 24 and 48 hours after termination of nicardipine infusion. Just before delivery 1mL blood will be withdrawn. Haemodynamic monitoring is continuous. NT-proBNP will be taken before initiation, during steady state, before delivery, post delivery and 6 months post partum.
    Bloedmonsters worden afgenomen voor start nicardipine en voor iedere dosis verandering. Na start en na iedere dosis veranderingen wordt bloed afgenomen na 15, 30min, 1 en 2uur. Indien streefbloeddruk behaald is wordt bloed afgenomen elke 6uur gedurende maximaal 48uur. Na beeindigen van nicardipine infusie wordt bloedafgenomen na 1,2,4,8,12,24 en 48uur. Net voor de bevalling wordt bloedafgenomen. Haemodynamische monitoring is continue. NT-proBNP bepalingen worden gedaan voor start nicardipine, tijdens stabiele situatie, net voor de partus, net na de partus en 6 maanden post partum.
    E.5.2Secondary end point(s)
    Determine concentration gradient to breastmilk. Determine pharmacokinetic parameters in the neonate and if appropriate correlate neonatal pharmacokinetic parameters to neonatal pharmacodynamic changes. Exploring haemodynamic changes in preeclamptic patients with severe hypertension and exploring the haemodynamic transfer to normal in the puerperium.
    Bepalen concentratie gradient naar borstvoeding. Bepalen pharmacokinetische kenmerken bij de neonaat en, indien mogelijk, bepalen van de correlatie tussen pharmacokinetsiche en farmacodynamische parameters bij de neonaat. Onderzoeken van haemodynamische veranderingen ten gevolge van preeclampsie gecompliceerd door ernstige hypertensie. Onderzoeken van haemodynamische veranderingen naar normaal in het kraambed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After delivery breast milk is collected with a maximum of one sample per day with a maximum period of 72 hours.
    After cord clamping both arterial and venous cord samples (1mL) are taken. A maximum of 3% of the total neonatal circulating volume will be used for this research with blood samples equally distributed in the sample period. The maximum period of neonatal blood sampling is 72 hours. In this period 3 to maximal 6 samples will be taken depending on the weight of the neonate. Haemodynamic parameters will be taken 3 and 6 months post delivery and single measurements will be done in the control group A blood sample for measurement of NT-proBNP will be taken 3 and 6 months post partum and in the control group.
    Na de bevalling wordt borstvoeding verzameld (1 sample per dag) gedurende maximaal 72uur. Na afklemmen van de navelstreng wordt veneus en arterieel bloed afgenomen. Bij de neonaat wordt maximaal 3% van het circulerend volume afgenomen voor dit onderzoek gedurende een maximale periode van 72uur. In deze periode worden maximaal 3 to 6 samples afgenomen afhankelijk van het gewicht van de neonaat. haemodynamische parameters worden bepaald 3 en 6 maanden post partum en een enkele meting wordt gedaan in de controle groep. NT-pronBNP bepaling wordt gedaan eenmalig 3 en 6 maanden post partum en eenmalig in de controle groep.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    prospectief observationeel
    prospective observational
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 20
    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 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 Yes
    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 state20
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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