E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who have suffered a first-ever symptomatic unprovoked VTE episode (proximal deep Vein thrombosis and/or pulmonary embolism) who receive initial treatment with unfractioned or low-molecular-weight heparin (or effective alternative) and warfarin for 3-12 months |
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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 | 10014522 |
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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 Sulodexide is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for two years after the initial 3-12 months of oral anticoagulant therapy in patients with unprovoked (defined as not triggered by: major/orthopaedic surgery, immobilization due to setting for more than 4 days and due to plaster, major trauma) venous thromboembolism |
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E.2.2 | Secondary objectives of the trial |
-Time to VTE new episode -Isolated distal deep vein thrombosis of the legs -Superficial vein thrombosis of the legs -Post thrombotic syndrome -Incidence of major vascular events (Acute Myocardial Infarction, Stroke) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age ≥18 years, of both sexes and any ethnical group -Patients treated with anticoagulant therapy (with VKA) for 3-12 months due to a documented previous unprovoked (defined as not triggered by: major/orthopaedic surgery, immobilization due to setting for more than 4 days and due to plaster, major trauma) DVT or PE -Patients who stopped VKA therapy from more than 1 week and less than 3 months |
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E.4 | Principal exclusion criteria |
Secondary VTE (due to major/orthopaedic surgery, immobilization due to setting for more than 4 days and due to plaster, major trauma) - Current pregnancy or during puerperium (first 6 weeks after birth) at the time of examination for inclusion in the study -Pulmonary embolism associated with shock or life threatening prolonged hypotension or persistence of pulmonary hypertension after pulmonary embolism -Two or more documented episodes of proximal VTE of lower limbs and/or pulmonary embolism -DVT in areas other than lower limbs -Isolated distal DVT (thrombosis of calf) |
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E.5 End points |
E.5.1 | Primary end point(s) |
-New episode of proximal deep vein thrombosis of lower limb -New episode of pulmonary embolism -Death due to documented new VTE episode complications |
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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 | 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) | 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 | 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
| 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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
| |
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 | 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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |