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    Summary
    EudraCT Number:2017-003180-35
    Sponsor's Protocol Code Number:R04725
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-04-30
    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 number2017-003180-35
    A.3Full title of the trial
    Feasibility study on the effects of postnatal enalapril on maternal cardiovascular function following preterm pre-eclampsia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Enalapril to improve heart function following preterm pre-eclampsia.
    A.3.2Name or abbreviated title of the trial where available
    PICk-UP
    A.4.1Sponsor's protocol code numberR04725
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03466333
    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 SponsorManchester University NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportMedical Research Council
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLynne Webster
    B.5.2Functional name of contact pointSponsor's representative
    B.5.3 Address:
    B.5.3.1Street AddressManchester University NHS Foundation Trust
    B.5.3.2Town/ cityManchester
    B.5.3.3Post codeM13 9WL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01612764125
    B.5.6E-maillynne.webster@mft.nhs.uk
    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 UKPAR enalapril maleate
    D.2.1.1.2Name of the Marketing Authorisation holderMedreich plc
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameUKPAR enalapril maleate
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 INNEnalapril maleate
    D.3.9.1CAS number 76095-16-4
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 20
    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 placeboCapsule
    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
    Postnatal (PN) cardiovascular dysfunction following preterm pre-eclampsia (pPE)
    E.1.1.1Medical condition in easily understood language
    Heart and vessel dysfunction following preterm pre-eclampsia.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10036485
    E.1.2Term Pre-eclampsia
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10036485
    E.1.2Term Pre-eclampsia
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040444
    E.1.2Term Severe pre-eclampsia
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10007648
    E.1.2Term Cardiovascular disease, unspecified
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Process outcome:
    - Recruitment rate (number of women eligible, recruited and completing the study per month).
    Primary Clinical outcome:
    - Reduction in total vascular resistance (TVR) (from baseline to 6 months post-randomisation following treatment with enalapril, compared with placebo). Whilst TVR is the nominated primary endpoint for this feasibility study, the choice of primary outcome for the definitive trial remains uncertain.


    E.2.2Secondary objectives of the trial
    Secondary process outcome:
    1. Acceptability of the intervention to postnatal women.
    Secondary clinical outcomes:
    1. A change in other parameters of cardiac function (including: E/E’ ratio, tricuspid valve regurgitation, left atrial volume index (LAVi), left ventricular function (LVEF), cardiac output (CO), stroke volume (SV), relative wall thickness (RWT), left ventricular mass index (LVMi), concentric/eccentric remodelling, global longitudinal strain (GLS), left ventricular (LV) basal strain, LV apical strain);
    2. A change in biomarkers (high sensitivity troponin (hs-cTnT), placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFlt1), N-terminal pro-brain natriuretic peptide (NTproBNP), nitric oxide end products (NOx));
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Excretion of enalapril in breastmilk (V1.0, 14.02.2018).
    Objectives: to quantify the amount of enalapril excreted into breastmilk.
    This sub-study is dependent on adequate funding and therefore may not be able to be completed.
    E.3Principal inclusion criteria
    - Diagnosis of preterm pre-eclampsia (pPE) in this pregnancy requiring delivery <37 weeks gestation: new or worsening hypertension >20 weeks with proteinuria or other features suggestive of PE (abnormal haematological, biochemical parameters, fetal growth restriction and/or low PlGF)
    • Biochemical / haematological cut-offs:
    - Platelet count <100 x109/L
    - Alanine amino transferase > 50units/L
    - Creatinine >90mmol/L

    • FGR:
    - Abdominal circumference (AC) / estimated fetal weight (EFW) <3rd centile
    - Or 2 of the following:
    - AC/EFW <10th centile
    - AC/EFW crossing centiles by >2 quartiles
    - Cerebroplacental ratio <5th centile
    - Umbilical artery PI >95th centile

    - At time of randomisation:
    • Postpartum, within 3 days of delivery
    • Aged 18 years or over
    • Able to provide informed consent
    • Serum creatinine <100 mmol/l
    E.4Principal exclusion criteria
    • Inability to consent
    • Known cardiac disease
    • Contraindication to ACE inhibitors
    • Current ACE inhibitor / ARB use
    • Renal artery stenosis
    E.5 End points
    E.5.1Primary end point(s)
    Process outcome:
    Recruitment rate (number of women eligible, recruited and completing study per month).

    Clinical outcome:
    Reduction in total vascular resistance (TVR) from baseline to 6 months post-randomisation following treatment with enalapril, compared with placebo. Whilst TVR is the nominated primary endpoint for this feasibility study, the choice of primary outcome for the definitive trial remains uncertain.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be assessed at 6 months (26 weeks) post-randomisation.
    E.5.2Secondary end point(s)
    Process outcomes
    1. Acceptability of intervention in postnatal women
    Clinical outcomes:
    1. A change in other parameters of cardiac function (E/E’ ratio, tricuspid valve regurgitation, LAVi, LVEF, CO, SV, RWT, LVMi, concentric/eccentric remodelling, GLS, LV basal strain, LV apical strain)
    2. A change in biomarkers (hs-cTnT, PlGF, sFlt, NTproBNP, NOx)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary process outcome will be evaluated 6 months post-randomisation.

    Longitudinal analysis of the secondary clinical endpoints (using each participant as her own control) will be assessed at 6 weeks and 6 months post-randomisation.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    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
    The end of the trial is the date of database lock, as defined in the PICk-UP Data Management Plan. At the time of database lock, data entry privileges are withdrawn from the trial database. End of trial unblinding will be performed by the Clinical Trials Pharmacy (once approved by Sponsor and TSC statistician). The trial may be closed prematurely by the TSC. The end of trial is not defined as last visit of the last patient because there will still be data queries following this point.
    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 months6
    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 months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    Participants will be asked if they would consent to be contacted in the future, as part of a cohort study. After the 6 month intervention, participants will be followed up by their GP with at least annual BP checks and will be offered a pre-conception appointment with the clinical team prior to any future potential pregnancy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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