E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of venous thromboembolism |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012108 |
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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 objective of this tiral is to assess the efficacy and safety of BAY 59-7939 10mg once daily dosing in extented prevention of VTE in men and women aged 18 years or above undergoing elective total hip replacement |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male and famale pyrients aged 18 years or above Patients scheduled for elective total hip replacement Ptients written informed consent for participation after detailed written and oral previous information to any study specific procedures |
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E.4 | Principal exclusion criteria |
1. Planned, staged total bilateral hp replacement. 2. Activebleeding or high risk of bleeding contaĆraindicating treatment with low molecular wight heparin. 3. Contraidictions listed in the labeling or conditions precluding patient treatment with enoxaparin. 4. Conditions prohibiting bilateral venography (amputation of one leg, allergy to contrast media). 5. Pregnant and breast-feeding women. Women with chlid-bearing potential not using adequate birth control method (Note: as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible both partners should use adequate barrier birth control). 6. Drug- alcohol abuse. 7. Concomitant use of HIV-protease inhibitors. 8. Therapy with another investigational product within 30 days prior start of study. 9. Planed intermittent pneumatic compression during active treatment period 10. Concomitant participation in another trial or study. 11. Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator (see section 4.5.7 of the study protocol) 12. For otehr concomitant medication not allowed se section 4.5.7 of the study protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endponit is defined as a composite endpoint of: . Any DVT (proximal and/or distal) and . Not fatal PE and . Death from all casues. The analysis of teh primary efficacy endpoint will be solely based on the assessments made by Venography and the VTE Adjunction Committees.
Secondary endpoints are: - Incidence of the composite endpoint comrising proximal DVT, non-fatal PE and VTE-related death (referred to as ,major VTE,)
. Incidence of the composite endpoint that results from the primary endpoint by substituinting VTE related death for all death (composite of any DVT and nonfatal PE a VTE-related death)
. Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE related death (composite of proximal DVT and nonfatal PE and death from all causes) . Incidence of symptomatid VTE (DVT, PE) . Incidence of DVT (total, proximal, distal) . Incidence of symptomatic VTE during follow-up (i.e. after the end of the time window for primary efiicacy assessment)
The analysis of the secondary efficacy endpoints related to VTE will be solely based on the assessment made by the Venography and VTE Adjunction committes. A further study endpoints is health care resource utilization, assessed by duration of hospitalization, any re-hospitalization during entire study period, and rehabilitaion center stay folowing hospital discharge. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | |
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 | 3 |