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    Summary
    EudraCT Number:2015-001092-49
    Sponsor's Protocol Code Number:VPA-03
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-03-30
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-001092-49
    A.3Full title of the trial
    Valproic acid regulation of plasma PAI-1
    Valproinsyras reglering av plasma PAI-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    How valproic acid affects the body's own ability to dissolve blood clots
    Hur valproinsyra påverkar kroppens egen förmåga att lösa upp blodproppar
    A.4.1Sponsor's protocol code numberVPA-03
    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 SponsorSahlgrenska Akademien Wallenberglaboratoriet
    B.1.3.4CountrySweden
    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 supportSahlgrenska University Hosptal
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska Akademien
    B.5.2Functional name of contact pointWallenberglaboratoriet
    B.5.3 Address:
    B.5.3.1Street AddressBruna Stråket 16
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code413 45
    B.5.3.4CountrySweden
    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 Ergenyl Retard
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi, Box 30052 104 25 Stockholm
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameErgenyl Retard 500 mg
    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 INNVALPROIC ACID
    D.3.9.1CAS number 99-66-1
    D.3.9.4EV Substance CodeSUB00015MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    The fibrinolytic system
    Fibrinolytiska systemet
    E.1.1.1Medical condition in easily understood language
    A bodily process that prevents blood clots
    En process i kroppen som motverkar blodets koagulation.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10016611
    E.1.2Term Fibrinolytic activity increased
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary purpose of this study is to examine the mechanisms with VPAs down-regulating effect on PAI-1 in humans
    Det primära syftet med studien är att att undersöka vilka mekanismer som ligger bakom VPAs nedreglerande effekt på PAI-1 i människa
    E.2.2Secondary objectives of the trial
    Not applicable
    Ej tillämpligt
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For all subjects:
    1.Subect has given informed consent
    2.Men and women aged 20 -85 years
    3.Non smoker
    Additional for patients with coronary artery disease:
    4.Pronounced atherosclerosis
    5.Treatment for acute myocardial infarction for more than a year ago
    6.Only Trombyl (no other anticoagulant therapy)
    För samtliga försökspersoner:
    1.Försökspersonen har givit sitt informerade samtycke
    2.Män och kvinnor i åldrarna 20 –85 år
    3.Ickerökare
    Dessutom för patienter med kranskärlssjukdom:
    4.Utalad åderförkalknings sjukdom
    5.Behandlats för akut hjärtinfarkt för mer än ett år sedan
    6.Ingen annan antikoagulantiabehandling frånsett Trombyl
    E.4Principal exclusion criteria
    1.Smoking
    2.BMI (body mass index) >35 kg / m²
    3.Epilepsy
    4.Uncontrolled hypertension
    5.Malignancy
    6.Mental disorder
    7.Alcoholism
    8.All forms of chronic illness with medications that are contraindicated to combine with Ergenyl
    9.Acute infection
    10.Difficulties in implementing the study with regard to the inability to lie still on a gurney because of the general condition or obvious difficulty with putting vein / artery catheter
    11.Interaction with Ergenyl
    12.Known hypersensitivity to valproic acid or other component included
    13.Ongoing or planned pregnancy within the next 3 months
    14.Breastfeeding women
    15.Suspected or actual inability to perceive the study of information and instruction
    1.Rökning
    2.BMI (body mass index) > 35 kg/m²
    3.Epilepsi,
    4.Okontrollerad hypertoni
    5.Malignitet
    6.Psykisk störning
    7.Alkoholism
    8.All form av kronisk sjukdom med mediciner som är kontraindicerat att kombinera med Ergenyl
    9.Akut infektion
    10.Svårigheter att genomföra studien med hänsyn till oförmåga att ligga still på en brits pga allmäntillståndet eller uppenbara svårigheter med att sätta ven/artär-kateter
    11.Interaktion med Ergenyl (se FASS)
    12.Känd överkänslighet mot Valproinsyra eller annan ingående komponent
    13.Pågående eller planerad graviditet inom närmaste 3 månaderna
    14.Ammande kvinnor
    15.Misstänkt eller konstaterad oförmåga att uppfatta studieinformation och instruktion
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the analysis of PAI-1 during VPA treatment
    Primär endpoint är analyser av PAI-1 under VPA behandling
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples will be drawn at 08, 12 and 17 at each visit for the analysis of study parameters
    Blodprover dras kl. 08, 12 och 17 vid varje besök för analys av studieparametrar
    E.5.2Secondary end point(s)
    Fibrinolysfaktorer (PAI-1, t-PA, u-PA, D-dimer, fibrinogen etc.), blood flow, blood pressure, heart rate and lactate levels will be analyzed
    Fibrinolysfaktorer (PAI-1, t-PA, u-PA, d-dimer, fibrinogen etc), blodflöde, blodtryck, hjärtfrekvens, och laktatnivåer kommer att analyseras
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples will be drawn at 08, 12 and 17 at each visit for the analysis of study parameters
    Blodprover dras kl. 08, 12 och 17 vid varje besök för analys av studieparametrar
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Mechanistic explorative pharmacokinetic study
    Utforskande studie
    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 Yes
    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 No
    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
    The study duration for each subject will vary between 2-4 weeks. The last visit of the last subject is defined as the completion of trial
    Studiens längd för varje enskild försöksperson varierar mellan 2-4 veckor. Sista besöket för sista försökspersonen i studien definieras som avslutad prövning
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state100
    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)
    General stopping criteria: anaphylactic reaction, hypersensitivity to study medication, unwanted effects of the study drug.
    At each visit: Blood pressure, ECG, safety blood tests. Possible side effects will be registered and immediately taken care of
    Patients will be treated in the usual manner within the medical and health care after finalised study.
    Generella stoppkriterier: anafylaktisk reaktion, överkänslighet mot studieläkemedlet, oönskade effekter av studieläkemedlet.
    Vid varje besök: Blodtyck, ECG, rutinblodprover. Eventuella biverkningar noteras och åtgärdas direkt.
    Patienterna kommer efter avslutad undersökning att behandlas på sedvanligt sätt inom sjuk-och hälsovården.
    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 Decision2015-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-25
    P. End of Trial
    P.End of Trial StatusOngoing
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