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 |
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 is to assess the efficacy and safety of BAY 59-7939 10 mg once daily dosing in prevention of VTE in men and women aged 18 years or above undergoing elective total knee replacement. |
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E.2.2 | Secondary objectives of the trial |
A further study endpoint is health care resource utilization, assessed by duration of hospitalization, any re-hospitalization during the entire study period, and rehabilitation center stay following hospital discharge. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Male and female patients aged 18 years or above •Subjects scheduled for elective total knee replacement •Subjects' written informed consent for participation after receiving detailed written and oral information prior to any study specific procedures |
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E.4 | Principal exclusion criteria |
•Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin •Contraindication listed in the labeling or conditions precluding subjects treatment with enoxaparin or requiring dose adjustment (eg, severe renal impairment) •Conditions prohibiting bilateral venography (eg, amputation of one leg, allergy to contrast media) •Pregnant and breast-feeding women. Women with child-bearing potential not using adequate birth control method. •History of ongoing drug- or alcohol abuse •Treatment with strong inhibitors of cytochrome P450 3A4, such as ketoconazole or protease inhibitors, within 4 days before randomization, or planned treatment during the time period of the study •Significant liver disease (eg, acute clinical hepatitis, chronic active hepatitis, cirrhosis) •Therapy with another investigational product within 30 days prior to start of study •Planned intermittent pneumatic compression during active treatment period •Concomitant participation in another trial or study •Other concomitant medications not allowed (see Section 4.5.7 of the protocol) •Subjects for whom therapy with anticoagulants cannot be stopped in the opinion of the investigator/physician (eg, phenprocoumon, warfarin-sodium, heparins, and Factor Xa inhibitors other than study medication) |
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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 ICAC and the AC/VTE.
The major secondary efficacy endpoint is: •Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE-related death (referred to as ‘major VTE’)
Further secondary endpoints are given by: •Incidence of DVT (total, proximal, distal) •Incidence of symptomatic VTE (DVT, PE) •Incidence of symptomatic VTE during follow-up (i.e. after the end of the time window for primary efficacy assessment). •'Net clinical benefit' assessed by the composite endpoint comprising major VTE and treatment-emergent major bleeding (as defined in Section 4.6.2) •Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death (composite of any DVT [proximal and/or distal] 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) The analysis of the secondary efficacy endpoints related to VTE will be solely based on the assessments made by the ICAC and AC/VTE. |
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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 | Yes |
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 | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 36 |
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 | 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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |