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    Summary
    EudraCT Number:2009-012968-13
    Sponsor's Protocol Code Number:UCL08/0350
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-30
    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 number2009-012968-13
    A.3Full title of the trial
    A Proof of Principle, Double-Blind, Randomised Placebo-Controlled,Multi-centre Trial of pravaStatin to Ameliorate Early Onset Pre-eclampsia
    A.3.2Name or abbreviated title of the trial where available
    StAmP
    A.4.1Sponsor's protocol code numberUCL08/0350
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN23410175
    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 SponsorUniversity College London
    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 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 Yes
    D.2.1.1.1Trade name Pravastatin
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA UK Ltd
    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 namePravastatin
    D.3.4Pharmaceutical form Capsule
    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 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
    Pre-eclampsia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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 16.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the trial is to establish whether pravastatin will lead to a significant reduction of circulating anti-angiogenic factors in women with early-onset pre-eclampsia. To test this hypothesis, we will ask the following questions:
    1. Does pravastatin cause a greater inhibition of circulating anti-angiogenic factors in women with early-onset pre-eclampsia compared with placebo?
    2. Are there any beneficial or adverse clinical effects to the mother or the baby following gestational exposure to pravastatin?
    3. If pravastatin appears to safely inhibit circulatating anti-angiogenic factors, how best can a substantive trial/health technology assessment be undertaken to develop guidance for routine use of statins to prevent or ameliorate pre-eclampsia?
    E.2.2Secondary objectives of the trial
    Should data from this trial suggest that statins are a promising therapy for pre-eclampsia, a larger substantive trial will be developed in asymptomatic women at risk of pre-eclampsia to answer the following questions:
    1. Can statins delay progression to pre-eclampsia in women at high-risk of the condition?
    2. Can pravastatin reduce the severity of early-onset pre-eclampsia and if so, how much additional gestational time can be gained?
    2. Do statins improve fetal and maternal outcome?
    3. What are the rates of any adverse effects to the mother or the baby?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be randomised into the StAmP trial, all eligibility criteria must be satisfied. Investigators will be asked to confirm each eligibility criteria at randomisation.
    Inclusion Criteria:
    To be eligible for the StAmP Trial, the women must:
    1. Aged above 16 years
    2. Be between 24+0 weeks’ and 31+6 weeks’ gestation
    3. Have a singleton pregnancy
    4. Have a diagnosis of early onset Pre-eclampsia (according to definition below)
    5. Be considered capable of safely continuing the pregnancy for 48 hours or more, as determined by the attending clinician
    6. Obstetrician and neonatologist believe the fetus is likely to be viable
    7. No major anomalies evident on the 20-week anomaly scan. Any anomaly should be assessed by the Principal Investigator and discussed with the Chief Investigator, following classification of the anomaly according to the ICD10 codes. All major anomalies will be excluded, but minor anomalies, subject to agreement between the PI and CI will be included
    8. Be capable of understanding the information provided, with use of an interpreter if required
    9. Give written informed consent

    Definition of Pre-eclampsia (24-31+6 weeks gestation)
    The minimum clinical criteria required to establish a diagnosis of pre-eclampsia are the first two criteria below. The third criterion is relevant if there is chronic hypertension, preceding pregnancy. The other criteria (4-6) are often present in early pre-eclampsia, but are not essential for diagnosis for pre-eclampsia.
    1. New onset hypertension after 20 weeks gestation defined as diastolic BP greater than 90 mmHg, using Korotkoff sound 5 to define the diastolic level.
    2. New onset proteinuria 2+ or more on standard urinary dipstick tests confirmed by proteinuria PCR ratio of greater than 30mg/mmol on spot urine test or >300mg/24 hours on a 24 hour urine collection.
    3. Women who have chronic hypertension, the appearance of new onset proteinuria, (defined above), a sudden increase of blood pressure, thrombocytopenia (platelets <100), elevated transaminases, or a sudden increase in proteinuria in those who have pre-existing proteinuria.
    4. Liver transaminases may be increased
    5. Serum creatinine (SCr) may be increased
    6. Platelet count may be decreased
    E.4Principal exclusion criteria
    Any women, who at the point of randomisation, exhibit any of the following are not eligible for the trial:
    1. Eclampsia
    2. Current use of statins
    3. Contraindications to statin use (other than pregnancy) including:
    - Hypersensitivity to pravastatin or any of its excipients
    - Active liver disease or elevation of serum transaminases not thought to be related to pre-eclampsia
    - Pre-pregnant renal insufficiency (creatine clearance <30ml/min)
    - Concomitant administration of potent CYP3A4 inhibitors
    4. Imminent transfer to a non-trial centre due to unavailability of neonatal cots.
    5. Participation in any other blinded, placebo-controlled trials of investigational medicinal products in pregnancy.
    6. Significant uncertainty regarding gestational age. Under 24 weeks' gestation, pregnancies are often not considered viable and therefore women with pre-eclampsia less than 24 weeks gestation will be excluded. Women with pre-eclampsia around 32 weeks’ gestation are often delivered when the mother is stable and therefore we will exclude women who develop pre-eclampsia over 32 weeks’ gestation. For this reason, if there is any uncertainty about the gestational age, the mother should not be approached for randomisation.
    7. Women who are HIV or hepatitis B positive
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure will be the effect of pravastatin on sFlt-1 individually during the first 72 hours post-randomisation.
    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 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 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.8.4.1Number 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
    The interventional phase of the trial will end when the last participant has delivered her baby. The observational phase of the trial will cease when the 6 week follow-up has been completed for the last participant recruited.
    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 days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    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: 0
    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 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 state64
    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)
    Study drug treatment will continue until delivery of the baby, so no long term provision of study drug is required.
    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 Aston University
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-09
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