E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with paroxysmal atrial fibrillation |
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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 |
To assess the effect of Irbesartan on the atrial effective refractory period (AERP). |
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E.2.2 | Secondary objectives of the trial |
- To assess the effects of Irbesartan on the atrial functional refractory period (AFRP). - To assess the effects of Irbesartan on atrial conduction intervals, in subjects with paroxysmal AF. - To assess the dispersion of refractoriness.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1) Subjects whose signed written informed consent has been obtained 2) Subjects with documented (on at least one ECG at any moment) recurrent paroxysmal atrial fibrillation who have an indication (and are going to be admitted) for catheter ablation techniques for atrial fibrillation. 3) Men and women, ages 18 to 70 years |
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E.4 | Principal exclusion criteria |
1) Structural cardiopathy like hypertensive cardiopathy, familiar cardiomyopathy, LVH, valvular disease, CAD, amyloidosis. 2) AF due to a reversible cause 3) History of thromboembolism during the previous year, 4) Previously documented and /or at visit 1 long QTc > 450 msec 5) Recent MI (less than 6 months), recent stroke (less than 6 months), severe HTN , subjects who require ACEi/ARBs . 6) Subjects with significant liver disease and coagulation problems 7) Subjects with inability to follow protocol procedures according to the investigation 8) Subjects with dementia 9) Subjects unable to come back at all follow up visits 10) Subjects with known intolerance to ARBs 11) Subjects treated with ACEI or ARB during the previous 4 weeks are excluded. A two-week wash out period is permitted. 12) Subjects treated with amiodarone during the previous six months will be excluded. 13) Any drug that could modify electrophysiological parameters: Antiarrythmic drugs including digoxine 14) Drugs with effect on QT intervals like: a) Disopyramide, Dofetilide, Ibutilide, Procainamide, Quinidine, Sotalol, Bepridil. Probucol. b) Other drugs: Amiodarone, Arsenic trioxide, Cisapride, Calcium-channel blockers: lidoflazine c) Antiinfective agents: clarithromycin, erythromycin, halofantrine, pentamidine, sparfloxacin d) Antiemetic agents: domperidone, droperidol e) Antipsychotic agents: chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, Methadone 15) Prisoners or subjects who are compulsorily detained 16) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy outcome measure is the AERP. The secondary outcomes measured are: atrial functional refractory period (AFRP), and the time intervals of inter- and intra-atrial conduction. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | 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.8.5 | 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |