E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10003658 |
E.1.2 | Term | 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 DETERMINE WHETHER THE REPEATED I.V. BOLUSES METHOD GROUP 1 IS MORE EFFECTIVE IN GETTING A NORMAL SINUS RHYTHM SR COMPARED WITH A STANDARD QUICK INFUSION GROUP 2 WITHIN 20 MINUTES FROM THE BEGINNING OF TREATMENT PRIMARY ENDPOINT . |
|
E.2.2 | Secondary objectives of the trial |
1 MORE EFFICACIOUSNESS OF BOLUSES METHOD IN GETTING SR WITHIN 2 HOURS; 2 LESS SIDE EFFECTS WITH THE BOLUSES METHOD WITHIN 2 HOURS. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
PATIENTS WITH STABLE FOR AL LEAST ONE HOUR ACUTE AF 48 HOURS DURATION AND WITH VENTRICULAR RESPONSE RATE 70 BPM,WHOSE AGE RANGES FROM 18 TO 90 YEARS, PRESENTING TO THE EMERGENCY ROOM OR ARE ADMITTED IN A CARDIOLOGY ON NON-CARDIOLOGY DEPARTMENT. |
|
E.4 | Principal exclusion criteria |
CONGESTIVE HEART FAILURE - AMI ACUTE MYOCARDIAL INFARCTION - ARTERIAL HYPOTENSION BLOOD PRESSURE 100 MM OF HG - KNOWN OR CLINICALLY APPARENT MITRAL STENOSIS - HISTORY OF MYCARDIAL ISCHEMIA - ELECTROLYTE IMBALANCES - SIGNIFICANT HEPATIC OR RENAL DISEASE LIVER ENZYMES ALT OR AST AT LEAST TWICE NORMAL UPPER LIMITS OR CREATININE GREATER THAN TWO MG/DL - ACIDOSIS - SUSPECT OF PULMONARY EMBOLISM - PREGNANCY - PREVIOUS BIFASCICULAR BLOCK LBBB OR RBBB LPH IF MEAN HEART 120 BPM. |
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E.5 End points |
E.5.1 | Primary end point(s) |
TO DETERMINE WHETHER THE REPEATED I.V. BOLUSES METHOD GROUP 1 IS MORE EFFECTIVE IN GETTING A NORMAL SINUS RHYTHM SR COMPARED WITH A STANDARD QUICK INFUSION GROUP 2 WITHIN 20 MINUTES FROM THE BEGINNING OF TREATMENT PRIMARY ENDPOINT . |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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
| |
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 | 0 |
E.8.9.1 | In the Member State concerned days | |
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 | 0 |