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    Summary
    EudraCT Number:2020-003410-12
    Sponsor's Protocol Code Number:RG_19-169
    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:2020-12-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-003410-12
    A.3Full title of the trial
    Pregnancy ANtihypertensive Drugs: which Agent is best?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pregnancy ANtihypertensive Drugs: which Agent is best? (Giant PANDA)
    A.3.2Name or abbreviated title of the trial where available
    Giant PANDA
    A.4.1Sponsor's protocol code numberRG_19-169
    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 SponsorUniversity of Birmingham
    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 supportNational Institute of Health Research - The Health Technology Assessment Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointProfessor Lucy Chappell
    B.5.3 Address:
    B.5.3.1Street Address10th Floor North Wing, St. Thomas' Hospital
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.6E-maillucy.chappell@kcl.ac.uk
    D. IMP Identification
    D.IMP: 1
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Labetalol
    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 nameLabetalol
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLabetalol hydrochloride
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 2400
    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.IMP: 2
    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 Nifedipine
    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 nameNifedipine
    D.3.4Pharmaceutical form Modified-release tablet
    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 INNNifedipine
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 90
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypertension in pregnancy (chronic hypertension, gestational hypertension or pre-eclampsia)
    E.1.1.1Medical condition in easily understood language
    High blood pressure in pregnancy
    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
    RESEARCH QUESTION
    In women with pregnancy hypertension (P), what is the effect of treatment with nifedipine (I) versus labetalol (C) on severe maternal hypertension (O) and a composite of fetal or neonatal death, or neonatal unit admissions (O)?

    AIM
    To evaluate the effect of different antihypertensive drugs in pregnancy hypertension on maternal and fetal/neonatal outcomes.

    PRIMARY OBJECTIVE
    Primary objective: To evaluate if treatment with nifedipine (calcium channel blocker), compared to labetalol (mixed alpha/beta blocker) in women with pregnancy hypertension, reduces severe maternal hypertension without increasing fetal or neonatal death, or neonatal unit admission.
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVES
    • To investigate the effect of treatment with nifedipine versus labetalol on other secondary maternal and fetal/neonatal outcomes including patient reported outcome measures.
    • To evaluate the cost-effectiveness of nifedipine versus labetalol as antihypertensive drugs from an NHS perspective.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Embedded Study Within A Trial (SWAT)
    Giant PANDA Observational study
    E.3Principal inclusion criteria
    TRIAL INCLUSION CRITERIA:
    -Pregnancy 11+0 and 34+0 weeks’ gestation inclusive
    -Diagnosis of pregnancy hypertension (chronic/gestational hypertension or pre-eclampsia)
    -Clinician decision to initiate or continue use of antihypertensive drugs
    -Aged 18 years or over
    -Able to give informed consent

    OBSERVATIONAL STUDY INCLUSION CRITERIA:
    Women will be eligible to participant in the observational study at any gestational age up to and including 34+0 weeks. Women are able to take part in the observational study prior to 11+0 weeks gestation where use of any antihypertensive drugs prescribed in clinical care will be recorded but will not form part of the interventional trial.
    E.4Principal exclusion criteria
    TRIAL EXCLUSION CRITERIA:
    -Contraindication to either labetalol or nifedipine
    -Already taking both labetalol and nifedipine, and not able to be randomised to a single drug

    OBSERVATIONAL STUDY EXCLUSION CRITERIA:
    Neither exclusion criterion for the trial are relevant for the observational study. Women contraindicated to either labetalol or nifedipine and/or women already taking both labetalol and nifedipine and not able to be randomised to a single drug, are eligible for the observational study.
    E.5 End points
    E.5.1Primary end point(s)
    Maternal: Severe hypertension (proportion of days with a healthcare professional measured systolic blood pressure reading ≥160mmHg between randomisation and birth).

    Fetal/neonatal: Composite of fetal loss before birth or known neonatal death, or neonatal unit admission involving separation of the baby from the mother between randomisation up to primary hospital discharge or 28 days post-birth, whichever occurs sooner (with no double counting of outcomes).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to primary hospital discharge for each of the mother or baby post-birth, or 28 days post-birth, whichever occurs sooner.
    E.5.2Secondary end point(s)
    Clinical outcomes
    Maternal:
    Up to birth:
    •Mean antenatal systolic blood pressure (using highest systolic blood pressure per day as collected for the primary outcome)
    •Mean antenatal diastolic blood pressure (using highest diastolic blood pressure per day as collected for the primary outcome)
    •Proportion of days with an antenatal systolic hypertension blood pressure reading ≥140mmHg
    •Proportion of days with an antenatal diastolic hypertension blood pressure reading ≥90mmHg
    •New diagnosis of pre-eclampsia
    •Diagnosis of eclampsia
    •Diagnosis of Haemolysis, Elevated Liver enzymes, Low Platelets syndrome
    •Placental abruption
    •Severe maternal morbidity (fullPIERS consensus definition)
    o Components of severe maternal morbidity
    •Maternal death
    •Maternal stroke
    •Prescription of additional antihypertensive drug(s)
    •Prescription of alternative antihypertensive drug(s)
    •Persistence with allocated antihypertensive (time from randomisation to first discontinuation)
    •Discontinued allocated antihypertensive drug
    •Undesirable effects of allocated (and other) antihypertensive drug(s) (number of women and number of undesirable effects)
    •Total number of antenatal hospital inpatient days

    Medication-related self-reported outcomes:
    •Treatment satisfaction with allocated antihypertensive drug
    •Beliefs about allocated antihypertensive drug
    •Adherence to allocated (and other) antihypertensive drug(s)

    At delivery/birth:
    •Indicated delivery (induction of labour or prelabour rupture of membranes (PROM) with stimulation of labour or pre-labour Caesarean section)
    •Mode of onset of birth (spontaneous, induction of labour, PROM with stimulation of labour, pre-labour Caesarean section)
    o Indication for onset of birth

    Between birth and primary hospital discharge or 28 days post-birth, whichever occurs sooner:
    •New episodes of severe maternal morbidity (fullPIERS consensus definition)
    o Components of severe maternal morbidity
    •Maternal death

    Fetal and neonatal:
    Between birth and primary hospital discharge or 28 days post-birth, whichever occurs sooner, using denominator of all fetuses/ infants:
    •Fetal loss prior to 24 weeks’ gestation
    •Fetal loss ≥24+0 weeks’ gestation (stillbirth)
    •Known early neonatal death (up to 7 days from birth)
    •Known late neonatal death (between 7 and up to 28 days from birth)
    •Neonatal unit admission (separation of baby from mother)
    o Principal recorded indication for neonatal unit admission
    o Length of stay in neonatal unit (and level of care)
    •Major congenital abnormality as defined by EUROCAT
    •Mode of birth (spontaneous vaginal, assisted vaginal, Caesarean section)
    o Indication for mode of birth
    •Gestational age at birth
    •Preterm birth (<37 completed weeks’ gestation)
    •Preterm birth (<32 completed weeks’ gestation)
    •Birthweight
    •Birthweight centile
    •Birthweight small for gestational age (<10th centile for gestational age)
    •Umbilical arterial pH <7 at birth
    •Apgar score at 5 mins after delivery
    •Need for additional resuscitation at birth: intubation in the delivery room, resuscitation drugs or chest compressions
    •Need for respiratory support
    o Type of respiratory support needed
    •Need for treatment for neonatal hypoglycaemia (in those having blood glucose monitoring)
    o Type of treatment for hypoglycaemia
    •Lowest blood glucose measurement
    •Neonatal seizures
    •Intracranial haemorrhage
    •Necrotising enterocolitis
    •Number of days to reach full feeds without intravenous /parenteral nutrition support

    Process outcome:
    •Number of babies in whom blood glucose monitoring was indicated at birth
    •Indication for blood glucose monitoring
    •Blood glucose test performed

    Adverse events:
    •Adverse event recorded (number of women and number of adverse events)

    Health economic outcomes
    Maternal:
    Up to birth:
    •Health-related quality of life (EQ-5D-5L)
    •Number of outpatient contacts
    •Hospital inpatient length of stay by level of care (ITU, HDU, or ward)

    Between birth and primary hospital discharge or 28 days post-birth, whichever occurs sooner:
    •Hospital inpatient length of stay by level of care (ITU, HDU, or ward)

    Neonatal:
    Between birth and primary hospital discharge or 28 days post-birth, whichever occurs sooner:
    •Hospital inpatient days by level of care (NICU, HDU, SCBU, and postnatal ward)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to primary hospital discharge for each of the mother or baby post-birth, or 28 days post-birth, whichever occurs sooner.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number 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 concerned50
    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
    The end of study will be 3 months after the database lock.
    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 months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 2300
    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 state2300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2300
    F.4.2.2In the whole clinical trial 2300
    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)
    Both study drugs are recommended for use in the latest NICE guidelines for management of hypertension in pregnancy, which followed consultation with MHRA. Antihypertensive treatment is often switched immediately after birth in usual clinical care. The decision to continue or switch drugs after birth will sit with clinicians within the woman’s usual care team.
    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 Decision2020-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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