E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Paroxysmal Atrial Fibrillation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034039 |
E.1.2 | Term | Paroxysmal atrial fibrillation |
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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 oral supplementation of PUFAs on the frequency and duration of AF episodes in patients known to have paroxysmal atrial fibrillation with a high (≥10%) AF burden and who already have a pacemaker in situ. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the role of fish oils on inflammatory markers and co-relate the relationship to AF burden. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients who have PAF and a dual chamber pacemaker, who have shown an AF burden of ≥10% in the most recent pacing check and are not symptomatic from it.
New Criteria as per '2006/CD/013−VERSION−2-10/05/2007' substantial amendment.
The inclusion criteria specifies a very high rate of paroxysmal atrial fibrillation which is not necessary to show a difference. As the difference to be perceived is a percentage of the burdena realistic AF burden ( reflecting the clinical occurrence of Af in these patients) would enable us to recruit more patients with out influencing the significance of the difference that would be seen betwenn the active and the placebo group. Hence we wish to change the inclusion criteria relating to the Af burden to > or =3% Af burden to > or = 3% |
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E.4 | Principal exclusion criteria |
Patients with persistent atrial fibrillation. Patients who are already on class-1 or class-3 anti-arrhythmic therapy. Patients who have been taking omega-3 supplements or have done so within a three month period preceding enrolment.
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of mode switch episodes during pacemaker check (a surrogate for AF) as a measure of AF burden. |
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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 | 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 | Information not present in EudraCT |
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 | No |
E.8.1.6 | Cross over | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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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we have had great difficulty in recruiting patients due to the rigourous criteria we set ourselves for inclusion in the study ( PAF burden of >10%). Hence we wish to extend the period of recruitment for a further 2 years to enable us to recruit the required number of patients. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |