E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Blocking the angiotensin II type 1 receptor reduces systemic levels of oxidative stress markers and adhesion molecules compared to placebo in patients with persistent/permanent 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 |
Blocking the angiotensin II type 1 receptor reduces systemic levels of oxidative stress markers and adhesion molecules by more than 25% compared to placebo in patients with persistent/permanent atrial fibrillation.
Target: Examination of the study hypothesis in a prospective, randomized, placebo-controlled, double-blind crossover study in patients with persistent / permanent atrial fibrillation.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with persistent/permanent AF (> 2 months) CHADS2 Score > 2 Age ³ 18 Patient informed orally and in writing Written informed consent of the patient
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E.4 | Principal exclusion criteria |
§ Strong clinical evidence that prevents the temporary pause of therapy with AT II antagonists § Symptomatic bradycardia § Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use § Cardiac surgery or cardiac catheter ablation within the last 3 months § Typical angina pectoris symptoms at rest or during exercise § Known coronary artery disease with indication for intervention § Symptomatic peripheral vascular disease § Left ventricular ejection fraction < 35% § Myocardial infarction within 6 months of screening § Diastolic blood pressure > 110mm Hg at rest § Symptomatic arterial hypotension § Known renal artery stenosis § serum creatinin > 1.8 mval/l § chronic inflammatory disease § acute inflammatory disease (hsCRP > 20mg/L) § Relevant hepatic or pulmonary disorders § Hyperthyreosis manifested clinically and in laboratory § Known drug intolerance for AT II inhibitors § Females who are pregnant or breast feeding § Females of childbearing potential who are not using a scientifically accepted method of contraception § Participation in a clinical trial within the last 30 days § Drug addiction or chronic alcohol abuse § Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study, Evidence of an uncooperative attitude
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of systemic levels of oxidative stress markers and adhesion molecules(hsCRP, ICAM, VCAM, MCP-1, vWF, TGFb1, TNF-a, Interleukin-6, 8isoProstaglandinF2a) |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | Yes |
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 | 8 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 1 |