E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
long term prevention of recurrent symptomatic venous thromboembolism(VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10043634 |
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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 |
The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thromboembolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with a vitamin K antagonist (VKA). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives will be evaluated by the following endpoints: Eficacy - time to the composite of recurrent DVT, recurrent non fatal PE and fatal PE where fatal PE is defined as PE based on objective testing, but excluding unexplained death. -time to the separate components of the primary efficacy outcome. Safety -Time to all clinically major bleeding -All clinically relevant bleeding -deaths -Cardiovascular events |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Patients with confirmed symptomatic PE or proximal DVT who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) -Written informed consent |
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E.4 | Principal exclusion criteria |
-Younger then 18 years of age -Indication for VKA other than DVT and/or PE -Patients in whom anticoagulant treatment for their index PE or DVT should be continued -Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN -Creatinine clearance < 30 ml/min -Acute bacterial endocarditis -Active bleeding or high risk for bleeding -Uncontrolled hypertension (investigators judgment) -Intake of another experimental drug within the 30 days prior to randomization into the study -Life expectancy < 6 months -Childbearing potential without proper contraceptive measures, pregnancy or breast feeding (proper contraceptive measures are defined according to the note for guidance of non clinical safety studies for the conduct of human trials for pharmaceuticals, CPMP/ICH/286/95 modification; it include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy -Patients with known hypersensivity to dabigatran or any other component of the investigational product -Patients deemed unsuitable for inclusion by the investigator, because considered unreliable to comply with the requirements of the study and/or compliance with study drug administration, or because having any condition or disease which in the opinion of the investigator would not allow safe participation in the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy outcome is symptomatic recurrent VTE, i.e., the composite of recurrent DVT or fatal or non-fatal PE during the treatment period. |
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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 | 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 | 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.8.5 | The trial involves multiple Member States | Yes |
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 | 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
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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 | 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 | 9 |