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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-004950-27
    Sponsor's Protocol Code Number:VAL-02
    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:2012-11-13
    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 number2012-004950-27
    A.3Full title of the trial
    Effect of valproic acid on fibrinolysis in humans with atherosclerosis
    Effekt av valproinsyra på fibrinolysen i människa med åderförkalkningssjukdom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of valproic acid on fibrinolysis in humans with atherosclerosis
    Effekt av valproinsyra på fibrinolysen i människa med åderförkalkningssjukdom
    A.3.2Name or abbreviated title of the trial where available
    Valproinsyra, fibrinolys och åderförkalkning
    A.4.1Sponsor's protocol code numberVAL-02
    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 universitetssjukhuset
    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 universitetssjukhuset/SU Göteborg
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportSahlgrenska akademien, Göteborg
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska universitetssjukhuset
    B.5.2Functional name of contact pointKristina Svennerholm
    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
    B.5.4Telephone number+46(0)31342 1000
    B.5.6E-mailKristina.svennerholm@vgregion.se
    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-aventis AB, Box 14142, 167 14 Bromma
    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
    D.3.4Pharmaceutical form Prolonged-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 INNVALPROIC ACID
    D.3.9.1CAS number 99-66-1
    D.3.9.3Other descriptive nameErgenyl Retard
    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.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 Yes
    D.2.1.1.1Trade name Isuprel
    D.2.1.1.2Name of the Marketing Authorisation holderLicensförskrivning
    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 nameIsuprel
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNISOPRENALINE
    D.3.9.1CAS number 7683-59-2
    D.3.9.3Other descriptive nameIsuprel
    D.3.9.4EV Substance CodeSUB08330MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.2 to 0.4
    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 Yes
    D.3.11.13.1Other medicinal product typeIsoprenaline
    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
    Atherosclerosis
    Åderförkalkningssjukdom
    E.1.1.1Medical condition in easily understood language
    Atherosclerosis
    Åderförkalkningssjukdom
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10003601
    E.1.2Term Atherosclerosis
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine whether upregulation of tPA production by valproic acid results in increased tPA release from the endothelium in humans
    Att att undersöka om uppreglering av tPA-produktionen genom valproinsyra resulterar i ökad tPA-frisättning från endotelet i människa
    E.2.2Secondary objectives of the trial
    No
    Nej
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Given informed consent
    2. Men and women aged 50 -85 years
    3. Treated for acute myocardial infarction for ≥ 1 year ago
    4. Severe artherosclerosis (3-vessel disease, syntax score > 20)
    5. Non-Smoker
    6. No other anticoagulants except Trombyl
    1. Patienten har givit sitt informerade samtycke
    2.Män och kvinnor i åldrarna 50 –85 år
    3.Behandlats för akut hjärtinfarkt för ≥ 1 år sedan
    4.Utalad åderförkalknings sjukdom (3-kärlssjuka, syntax score över 20)
    5.Ickerökare
    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. Any form of chronic disease contraindicated to combine with Ergenyl
    9. Acute infection
    10.Inability to stay in a hospital bed because of general condition or due to obvious difficulties with putting vein/artery catheter
    11.Interaction between Ergenyl and the patient's medications
    12.Known hypersensitivity to valproic acid or any components contained
    13.Inability to understand study information and/or instructions
    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.Interaktionsproblematik mellan Ergenyl och patientens övriga medicinering
    12.Känd överkänslighet mot Valproinsyra eller annan ingående komponent
    13.Misstänkt eller konstaterad oförmåga att uppfatta studieinformation och instruktion
    E.5 End points
    E.5.1Primary end point(s)
    tPA release.
    Blood flow, blood pressure, heart rate, lactate levels and fibrinolysis fakcors will also be measured
    tPA-frisättning.
    Blodflöde, blodtryck, hjärtfrekvens, fibrinolysfaktorer och laktatnivåer kommer även att mätas
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks after Valpolic acid treatment
    Efter 4 veckors behandling med Valporinsyra
    E.5.2Secondary end point(s)
    No
    Nej
    E.5.2.1Timepoint(s) of evaluation of this end point
    No
    Nej
    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 Yes
    E.6.13.1Other scope of the trial description
    This is a hypothesis-generating research study, a methodology and model study
    Detta är en hypotesgenererande forskningsstudie; en metod och modellstudie
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Kontrollgruppen startar med aktivt läkemedel efter 6 veckor
    The control group starts with active drug after 6 weeks
    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.8.5The 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
    Study is defined as complete ("end-of-study") when the last patient completes the final study day
    Studien definieras som klar ("slut") när sista patienten genomgått sista studiedagen
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 state30
    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)
    Patients will be followed up according to routines within the health sector after study is completed.
    Patienterna kommer efter avslutad undersökning att behandlas på sedvanligt sätt inom sjuk-och hälsovården. Om patienterna måste uppsöka akut sjukvård pga blödningsproblematik från artärkatetriseringen efter avslutad undersökning kommer de ha en informationslapp avseende studieupplägget att visa till den behandlande läkaren.

    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 Decision2013-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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