E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hospitalized medical patients with moderate to severe renal insufficiency and indication to the use of pharmacological antithrombotic prophylaxis |
|
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 |
Main objective of the study is to evaluate the safety of a reduced dosage of fondaparinux for the prevention of venous thromboembolism in hospitalized medical patients with moderate/severe renal insufficiency |
|
E.2.2 | Secondary objectives of the trial |
Main objective of the study is to evaluate the efficacy of a reduced dosage of fondaparinux for the prevention of venous thromboembolism in hospitalized medical patients with moderate/severe renal insufficiency |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
.Age > 60 years. Hospitalization for one of the following diseases: heart failure NYHA class III/IV, acute respiratory insufficiency, acute infection or acute inflammatory diseases (arthritis, connective tissue diseases or inflammatory bowel diseases) .at least four days of hospitalization . Renal insufficiency defined by a creatinine clearance between 20 and 50 ml/min calculated using the MDRD formula .written informed consent |
|
E.4 | Principal exclusion criteria |
. Active Hemorrhage or in the previous three months .known hemorrhagic diathesis .platelet count < than 100.000 .Active treatment with unfractionated heparin, low molecular weight heparin or fondaparinux at therapeutic dosage or treatment with oral anticoagulant therapy. Previous administration of prophylactic doses of unfractionated heparin, low molecular weight heparin or fondaparinux from more than 48 hours .Life expectation < 1 month |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of major bleeding up to 48 hours after the last study drug administration |
|
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 | 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 | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 15 |
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 | 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
| |
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 | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |