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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012108 |
E.1.2 | Term | Deep venous thrombosis prophylaxis |
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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 trial is to compare the efficacy and safety of VTE prophylaxis with BAY 59-7939 10 mg once daily administered for 5 weeks to enoxaparin 40 mg once daily (qd) administered for 10-14 days followed by placebo 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 | No |
E.3 | Principal inclusion criteria |
Male and female patients aged 18 years or above. Patients scheduled for elective total hip replacement. Patients’ written informed consent for participation after receiving detailed written and oral previous information to any study specific procedures.
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E.4 | Principal exclusion criteria |
1. Planned, staged bilateral total hip replacement 2. Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin. 3. Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin. 4. Conditions prohibiting bilateral veno graphy (amputation of one leg, allergy to contrast media). 5. Pregnant and breast-feeding women. Women with child-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- or alcohol abuse. 7. Concomitant HIV-protease inhibitors. 8. Therapy with another investigational product within 30 days prior start of study. 9. Planned intermittent pne umatic compression during active treatment period. 10. Concomitant participation in another trial or study. 11. Other concomitant medications not allowed (see § 4.5.7 of the study protocol) 12. Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator. (see § 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 endpoint is defined as a composite endpoint of: - Any DVT (proximal and/or distal) and - Non fatal PE and - Death from all causes. The analysis of the primary efficacy endpoint will be solely based on the assessments made by the Venography and the VTE Adjudication Committees.
Secondary efficacy endpoints are: - Incidence of the composite endpoint comprising 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 substituting VTE related death for all death (composite of any DVT and nonfatal PE and 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 symptomatic 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 efficacy assessment).
The analysis of the secondary efficacy endpoints related to VTE will be solely based on the assessments made by the Venography and VTE Adjudication committees.
A further study endpoint is health care resource utilisation, assessed by duration of hospitalisation, any re-hospitalisation during the entire study period, and rehabilitation centre stay following 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 | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
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 | Yes |
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) | Yes |
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 | 3 |
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 |