E.1 Medical condition or disease under investigation |
E.1.1 | Medical 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. |
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E.1.1.1 | Medical 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. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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.2.2 | Secondary 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.4 | Principal 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
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E.5 End points |
E.5.1 | Primary 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After sufficient tissue collection. |
Na verzameling van voldoende materiaal. |
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E.5.2 | Secondary 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After sufficient tissue collection. |
Na verzameling van voldoende materiaal. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator 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. |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |