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    The EU Clinical Trials Register currently displays   37227   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-000896-26
    Sponsor's Protocol Code Number:ETLAS
    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:2016-03-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-000896-26
    A.3Full title of the trial
    Effect of Tadalafil on cerebral large arteries in stroke patients.
    Effekten af Tadalafil på hjernens store arterier i patienter med apopleksi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tadalafil and stroke.
    Tadalafil og slagtilfælde.
    A.3.2Name or abbreviated title of the trial where available
    Tadalafil and apoplexia.
    Tadalafil og apopleksi.
    A.4.1Sponsor's protocol code numberETLAS
    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 SponsorHerlev Gentofte Hospital
    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 supportHerlev Gentofte Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHerlev Gentofte Hospital
    B.5.2Functional name of contact pointChristina Rostrup Kruuse
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.4Telephone number4538681233
    B.5.6E-mailchristina.rostrup.kruuse@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 Cialis
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly
    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.3.4Pharmaceutical form Capsule
    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 INNTADALAFIL
    D.3.9.1CAS number 171596-29-5
    D.3.9.4EV Substance CodeSUB12602MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Stroke and small vessel disease.
    Apopleksi og småkarssygdomme.
    E.1.1.1Medical condition in easily understood language
    Stroke.
    Slagtilfælde.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10070879
    E.1.2Term Cerebral small vessel ischemic disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10076994
    E.1.2Term Lacunar stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to investigate the effect of the phosphodiesterase-5-inhibitor (PDE-5-inhibitor) tadalafil on blood flow velocity in the brain's large arteries and cortical brain oxygenation in patients with former lacunar strokes caused by small vessel diseases.
    Formålet med forsøget er at undersøge phosphodiesterase-5-hæmmeren (PDE-5-hæmmeren) tadalafils virkning på blodgennemstrømningen i hjernens store arterier samt kortikal iltmætning i hjernen hos patienter som tidligere har haft små blodpropper i hjernen forårsaget af småkarssygdomme.
    E.2.2Secondary objectives of the trial
    Secundary objectives is to investigate if tadalafil improves the peripheral endothelial function measured as an improved blood vessel respons in the fingers after a short occlusion of blood suply to the arm measured with EndoPAT2000.
    Besides that there will be a change in endothelial function markers in the blood after a single dosis of tadalafil and that these changes correspond to the measured peripheral or central blood vessel function.
    Feasibility of applying tadalafil in stroke patients.
    Sekundære formål er at undersøge om tadalafil forbedrer den perifere endothelfunktion målt som forbedret blodkarrespons i fingrene efter kortvarig afklemning af blodforsyningen til armen målt med EndoPAT2000.
    Derudover at der sker en ændring af endothelfunktionsmarkører i blodet efter en enkelt dosis tadalafil og at disse ændringer svarer til den målte perifere eller centrale blodkarsfunktion.
    Praktisk mulighed for at bruge tadalafil hos apopleksipatienter.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Radiological evidence of cerebral small vessel disease defined as: MRI evidence of lacunar infarct(s) (≤ 1.5 cm maximum diameter) and/or confluent deep white matter leukoaraiosis (≥ grade 2 on Fazekas scale).
    2. Clinical evidence of cerebral small vessel disease defined as:
    a) lacunar stroke syndrome with symptoms lasting >24 hours, occurring at least 5 months previously;
    OR
    b) transient ischaemic attack lasting < 24 hours with limb weakness, hemi-sensory loss or dysarthria at least 5 months previously AND with MR DWI performed acutely showing lacunar infarction, OR if MRI is not performed within 10 days of TIA, a lacunar infarction in an anatomically appropriate position is demonstrated on a subsequent MRI;
    3. Age ≥ 50 years.
    4. Imaging of the carotid arteries with Doppler ultrasound, CT angiography or MR angiography in the previous 12 months, demonstrating < 70% stenosis in both internal carotid arteries.
    1. Radiologiske beviser for cerebral småkarssygdom defineret som: MR-skanning visende lakunær infarkt(er) (≤ 1.5 cm maksimal diameter) og/eller konfluent dyb hvid substans leukaraiosis (≥ grad 2 på Fazekas skala).
    2. Kliniske beviser for cerebral småkarssygdom kan være:
    a. lakunær stroke syndrom med symptomer varende >24 timer, opstået for minimum 5 måneder siden;
    eller:
    b. transient iskæmisk attak (TIA) varende < 24 timer med ekstremitetsvaghed, hemi-sensorisk udfald eller dysartri for minimum 5 måneder siden OG med MR-DWI-skanning udført akut visende lakunær infarkt, ELLER hvis MR-skanning ikke er udført indenfor 10 dage efter TIA, er en lakunær infarkt påvist i en anatomisk korrekt position ved en efterfølgende MR-skanning.
    3. Alder ≥ 50 år
    4. Billeddiagnostik af karotis arterierne med Doppler ultralyd, CT angiografi eller MR angiografi i de foregående 12 måneder visende < 70 % stenose i begge a. carotis interna.
    E.4Principal exclusion criteria
    1. Known diagnosis of dementia
    2. Pregnancy or nursing women
    3. Cortical infarction (>1.5 cm maximum diameter)
    4. Systolic BP < 90 and/or diastolic BP < 50
    5. eGFR < 30 ml/min/1,73 m2
    6. Severe hepatic impairment
    7. History of Lactose intolerance
    8. Concomitant use of PDE5 inhibitors e.g. sildenafil, tadalafil, vardenafil
    9. Patients receiving nicorandil and nitrates e.g. isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate
    10. Body weight > 130kg
    11. Uncontrolled cardiac failure
    12. Persistent or paroxysmal atrial fibrillation
    13. History of ‘sick sinus syndrome’ or other supraventricular cardiac conduction conditions such as sinoatrial or atrioventricular block
    14. Uncontrolled COPD
    15. Stroke or TIA within the last 5 months.
    16. MRI not tolerated or contra-indicated : MRI exclusion criteria -Participant has a cardiac pacemaker; recent surgery; vascular clips; metal implants or joint replacements that are not compatible with MRI; have had metal fragments in their eyes; has ever worked on a lathe; has shrapnel from a war injury; possibility of pregnancy
    17. Known monogenic causes of stroke i.e. CADASIL
    18. The patient does not wish to know important results from MRI
    19. Unable to provide informed consent
    20. Not possible to localise a. cerebri media bilaterally on inclusion day with Transcranial Doppler.
    1. Diagnosticeret med kendt demens
    2. Graviditet eller ammende
    3. Kortikal infarkt (>1.5 cm i maksimal diameter)
    4. Systolisk blodtryk <90 mmHg og/eller diastolisk blodtryk <50 mmHg
    5. eGFR < 30 ml/min/1,73 m2
    6. Svær leverinsufficiens
    7. Laktoseintolerance
    8. Samtidig behandling med PDE-5-hæmmere f.eks. sildenafil, tadalafil eller vardenafil.
    9. Deltagere modtager nicorandil og nitrater f.eks. isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate
    10. Vægt > 130 kg
    11. Ukontrolleret hjertesvigt
    12. Persisterende eller paroksystisk atrieflimren
    13. Tidligere “syg sinus knude syndrom” eller andre supraventrikulære lednings-forstyrrelser så som sinoatrialt- eller atrioventrikulært blok
    14. Ukontrolleret KOL
    15. Apopleksi eller TIA indenfor de sidste 5 måneder
    16. MR-skanning kan ikke udføres eller kontraindiceret: MR-skannings eksklusions kriterier: Deltagere har pacemaker; fornylig blevet opereret; vakulære clips; metal-implantat eller ledprotese som ikke er MR kompatibel; har haft metalfragmenter i deres øjne; har tidligere arbejdet med en drejebænk; har granatsplinter fra en krigsskade; mulighed for graviditet
    17. Kendt monogen årsag til apopleksi f.eks. CADASIL
    18. Patienten ønsker ikke oplysninger om resultaterne af betydende tilfældige fund på MR-skanning.
    19. Ude af stand til at kunne give informeret samtykke
    20. Ikke muligt at lokalisere a. cerebri media bilateralt ved forundesøgelse vha. Transkraniel Doppler.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is changes in the mean blood flow velocity in the middle cerebral artery (MCA) and changes in cortical brain oxygenation.
    Primær endpoint er ændringer i den gennemsnitlige blodgennemstrømningshastigheden i a. cerebri media samt ændringer i iltmætning kortikalt i hjernen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to three hours after intake of tadalafil.
    Op til tre timer efter indtag af tadalafil.
    E.5.2Secondary end point(s)
    Peripheral endothelial function measured with EndoPAT2000.
    Endothelial function markers in blood.
    Perifer endothelfunktion mål med EndoPAT2000.
    Endothelfunktionsmarkører i blodet.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to three hours after intake of tadalafil.
    Op til tre timer efter indtag af tadalafil.
    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) 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 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.8.5The 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
    LVLS
    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 months0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-03-10. Yes
    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 state20
    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)
    None
    Ingen
    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 Decision2016-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-04
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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