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    Summary
    EudraCT Number:2012-002136-90
    Sponsor's Protocol Code Number:JH/TJ1_NAT_2012
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-18
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-002136-90
    A.3Full title of the trial
    Treatment of hypertension at nigth in type 1 diabetes patients with no 24 hour variation of thier bloodpressure.
    Natlig hypertenson behandling hos type 1 diabetespatienter med nedsat døgnvariation i blodtryk
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of hypertension at nigth in type 1 diabetes patients with no 24 hour variation of thier bloodpressure.
    Natlig hypertenson behandling hos type 1 diabetespatienter med nedsat døgnvariation i blodtryk
    A.4.1Sponsor's protocol code numberJH/TJ1_NAT_2012
    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 SponsorRigshospitalet
    B.1.3.4CountryDenmark
    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 organisationRigshospitalet
    B.5.2Functional name of contact pointKaren Lisa Hilsted
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4535459502
    B.5.5Fax number+4535452950
    B.5.6E-mailkaren.lisa.hilsted@rh.regionh.dk
    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 Enalaprilmaleat
    D.2.1.1.2Name of the Marketing Authorisation holderPhamaCoDane
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameEnacodan
    D.3.4Pharmaceutical form 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 INNEnacodan
    D.3.9.1CAS number 76095-16-4
    D.3.9.3Other descriptive nameENALAPRIL MALEATE
    D.3.9.4EV Substance CodeSUB01884MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20mg
    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
    Patients with type 1 diabetes with autonomic neuropathy or no 24h variation in bloodpressure.
    Patienter med type 1 diabetes med autonom neuropati eller ophævet døgnvariation i blodtryk
    E.1.1.1Medical condition in easily understood language
    Patients with insulin dependant diabetes and nervesystem disorders and no 24h variation in bloodpressure
    Patienter med insulinkrævende sukkersyge og nerveforstyrrelser og ingen 24 timers variation i blodtryk.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    Treatment of hypertension at nigth in patients with type 1 diabetes - with no 24h variation in bloodpressure implies a more suitable bloodpressure management, compared with conventional treatment (administration of drugs in the morning)
    Hypotese 1:
    Natlig antihypertensiv behandling hos type 1 diabetes patienter med nedsat døgnblodtryksvariation giver en øget og mere hensigtsmæssig variation i døgnblodtrykket, sammenlignet med administration om morgenen.
    E.2.2Secondary objectives of the trial
    Nocturnal bloodpressure treatment has a measurable effect on cardiovasculare risk factors, including left ventricular mass.
    Hypotese 2:
    Natlig antihypertensiv behandling har en målbar effekt på kendte kardiovaskulære risikofaktorer, herunder ventre ventrikels masse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Type 1 diabetes
    Age 18-65 years
    HbA1C < 1%
    Reduced heart rate variability
    Reduced 24h bloodpressure variability
    Normoalbinuria and no sigs of heartdisease
    Type 1 diabetes mellitus
    Alder 18-65 år
    HbA1C under 1%
    Nedsat hjertefrekvensvariabilitet
    Nedsat døgnvariation i blodtryk
    Normoalbuminuri og ingen tegn på hjertesygdom

    E.4Principal exclusion criteria
    Albinuria
    Se-createnine>120 mikromol/l
    Sleep apnea
    Workload at nigth
    A history of renal arthery stenosis or renal disease/nephrectimy
    Primor angiooedema or serius sideeffects during treatment with ACE-inhibitors or ANG11 - antagonist
    Everyday use of NSAID up to 4 weeks before inclusion
    Bad compliance
    Cancer or any other significant disease that could effect the trial
    Women planning a pregnancy, are pregnant or nursing
    Women who do not use contraception (contraceptive pill or IUD(Intra uterine device)
    Albuminuri
    Serumcreatinin > 120 mikromol/l
    Søvnapnø
    Arbejdsforhold med stort antal nattevagter
    Anamnese for nyreatreriestenose eller nyresygdom/nefretomi
    Tidligere forekomst af angioødem eller alvorlige bivirkninger under behandling med Ace-hæmmer eller ANGII - antagonist
    kronisk brug af NSAID, indtil 4 uger inden eventuel inklusion i forsøget
    Enhver tilstand der vanskeliggør samarbejde omkring efterfølgelse af protokollen, udfra investigators vurdering.
    Cancer eller anden klinisk signifikant sygdom eller lidelse, som efter investigators mening kan påvirke undersøgelsens resultater.
    Kvinder der planlægger graviditet, er gravide, eller ammer
    Kvinder, der ikke anvender præventionsmidler (p-piller eller IUD [intra uterine device])
    E.5 End points
    E.5.1Primary end point(s)
    Noctuenal bloodpresure reduction by antihypertensive treatment at nigth comperred with drug administration in the morning
    Natlig blodtryksfald ved medicinadministration til natten i forhold til medicinadminstration om morgenen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 uger
    E.5.2Secondary end point(s)
    Left ventricular mass
    Cardiac risk factors
    Vibrationperception threshold
    Venstre ventrikels masse
    Kardiologiske risikomakører i blodet
    Tærskel værdi for vibrationssans på benene
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 uger
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 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.8.5.1Number of sites anticipated in the EEA0
    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
    Date for First patient first visit 1.6.2012
    Date for Last patient last visit 1.10.2013

    Dato for Første patients første besøg 1.6.2012
    Dato for Sidste patienst sidste besøg 1.10.2013
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    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: 24
    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 Yes
    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 Yes
    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 state24
    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)
    Will be discussed with the doctor after end trial
    Vil blive besluttet i samråd med lægen efter endt forsøg
    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 Decision2012-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-19
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