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    Summary
    EudraCT Number:2015-003674-32
    Sponsor's Protocol Code Number:1.1:12-6-2015
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-10-26
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-003674-32
    A.3Full title of the trial
    The effect of Telmisartan on inflammatory processes in the vascular wall of abdominal aortic aneurysms.
    Het effect van Telmisartan op de ontstekingsactiviteit in de wand van het abdominale aneurysma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of the anti-hypertensive drug Telmisartan on inflammation in the vascular wall of an aneurysm of the abdominal aorta.
    Het effect van het bloeddrukverlagende middel Telmisartan op ontsteking in de wand van een aneurysma van de buikslagader.
    A.3.2Name or abbreviated title of the trial where available
    TELMI
    A.4.1Sponsor's protocol code number1.1:12-6-2015
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportLeiden University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointClinical trials vascular research
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.4CountryNetherlands
    B.5.4Telephone number031715263445
    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 Telmisartan
    D.2.1.1.2Name of the Marketing Authorisation holderACE Pharmaceuticals B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameTelmisartan
    D.3.2Product code RVG 105917
    D.3.4Pharmaceutical form Tablet
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Abdominal aortic aneurysm with an indication for elective open surgical repair.
    Aneurysma van de abdominale aorta met een indication voor een electieve open aneurysma operatie.
    E.1.1.1Medical condition in easily understood language
    Abdominal aortic aneurysm with an indication for a planned open aneurysm operation.
    Aneurysma van de abdominale aorta die in aanmerking komen voor een open operatie.
    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
    Exploring the possible effects of the selective angiotensin II type 1 receptor antagonist Telmisartan on inflammatory processes and matrix homeostasis in the human aneurysmal vascular wall.
    Exploratie van de potentiele effecten van de selectieve angiotensine II type 1 receptor antagonist Telmisartan op inflammatoire processen en matrix homeostase
    E.2.2Secondary objectives of the trial
    Comparing the effects of Telmisartan on inflammatory processes and matrix homeostasis in vascular wall with human AAA tissue from patients who've been using an ACE inhibitor and control AAA tissue.
    Vergelijking van de effecten van Telmisartan op inflammatoire effecten en matrix homeostase in de vaatwand met human AAA weefsel van patients die een ACE remmer hebben gebruikt en controle AAA weefsel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with an abdominal aortic aneurysm who are planned for elective open surgical repair.
    Patienten met een aneruysma van de abdominale aorta met een indicatie voor een geplande open aneurysma operatie.
    E.4Principal exclusion criteria
    1. Renal insufficiency; eGFR < 50 ml/min
    2. Bloodpressure < 110/70 mmHg
    3. Abnormal liver function (liver enzymes > 3 times elevated of normal value)
    4. Hypersensitivity for angiotensin II type 1 receptor antagonist or ACE inhibitor
    5. Current usage of angiotensin II type 1 receptor antagonist or ACE inhibitor
    6. Known significant renal stenosis (>70%) of one or both renal arteries
    7. Active gout
    1. Nierinsufficiëntie; creatinineklaring onder de 50 ml per minuut
    2. Bloeddruk < 110/70 mmHg
    3. Ernstige leverfunctie stoornissen (leverenzymen meer dan 3 maal verhoogd ten opzichte van de normaal waarde)
    4. Overgevoeligheid voor AT1R antagonist of ACE remmer
    5. Reeds gebruiken van een AT1R antagonist of ACE remmer
    6. Bekende nierarteriestenose
    7. Actieve jicht
    E.5 End points
    E.5.1Primary end point(s)
    Analysis of various markers for inflammatory processes, matrix homeostasis and cell proliferation in the human vascular wall after Telmisartan use.
    Analyse van diverse markers voor inflammatie, matrix homeostase en cel proliferatie in de humane aneurysma vaatwand na Telmisartan gebruik.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After sufficient tissue collection.
    Na verzameling van voldoende materiaal.
    E.5.2Secondary end point(s)
    Comparing markers for inflammatory processes, matrix homeostasis and cell proliferation in the human vascular wall after Telmisartan use with AAA tissue of patients who've been using an ACE inhibitor or controle tissue.
    Vergelijken van markers voor inflammatie, matrix homeostase en cel proliferatie in de humane aneurysma vaatwand na Telmisartan gebruik met AAA weefsel van patienten die een ACE remmer hebben gebruikt en controle weefsel.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After sufficient tissue collection.
    Na verzameling van voldoende materiaal.
    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 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 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 Yes
    E.8.2.3.1Comparator description
    Controle/ACE remmer AAA weefsel is reeds beschikbaar voor vergelijking in onze biobank
    Control/ACE inhibitor AAA tissue is already available for comparison in our biobank.
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    LVLS
    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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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 state15
    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
    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 Decision2015-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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