E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of acute deep vein thrombosis in elderly patients with impaired renal function |
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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 | LLT |
E.1.2 | Classification code | 10051055 |
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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 objective of this study is to compare the safety of innohep and unfractionated heparin (UFH) in terms of Clinically Relevant Bleedings in elderly patients with impaired renal function for initial treatment of acute deep vein thrombosis (DVT).
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E.2.2 | Secondary objectives of the trial |
A secondary objective of this study is to verify that innohep in elderly patients with impaired renal function is effective in terms of prevention of recurrences of venous thromboembolism (VTE).
Other secondary and tertiary objectives are to evaluate other safety endpoints under parallel treatment with innohep or unfractionated heparin (UFH) and oral anticoagulants (OAC) and to evaluate interactions between various baseline parameters in relation to secondary and tertiary response criteria. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Following receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out 2. Patients with a symptomatic and objectively confirmed VTE (lower limb DVT or PE) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography (performed within 48 hours prior to randomisation) 3. Patients with an indication for DVT treatment with SC LMWH or UFH followed by OAC for at least 90 Days 4. Hospitalised patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in hospital or in an out-patient setting 5. Patients with a creatinine clearance ≤ 60 mL/min calculated according to the Cockcroft-Gault formula 6. Age equal to or more than 75 years 7. Male or female 8. Any ethnic origin
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E.4 | Principal exclusion criteria |
1. Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation 2. Patients on oral anticoagulant treatment at or within last 1 week prior to randomisation 3. Patients with a symptomatic VTE requiring thrombolytic therapy or invasive intervention 4. End Stage Renal Disease patients requiring dialysis 5. Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period 6. Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40 at randomisation and during the SC anticoagulant treatment period 7. Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer) 8. Patients with a platelet count < 100.000.000.000/L 9. Patients with a known history of heparin-induced thrombocytopenia 10. Patients with known severe hepatic insufficiency manifested in a INR ≥ 1,5 11. Patients with an uncontrolled severe hypertension i.e. a systolic blood pressure > 220 mm Hg or diastolic blood pressure > 120 mm Hg at at least 2 measurements within 24 hours prior to randomisation 12. Patients with ischaemic stroke at or within the last 1 week prior to randomisation 13. Patients with a known haemorrhagic stroke within 3 months prior to randomisation 14. Patients with a known bacterial endocarditis within 3 months prior to randomisation 15. Known or suspected hypersensitivity to component(s) of Investigational Products. 16. Current participation in any other interventional clinical trial 17. Patients who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 1 month 18. Patients previously randomised in this trial 19. Patients known or suspected of not being able to comply with the trial protocol (e.g. cognitive impairment, alcoholism, drug dependency or psychotic state).
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinically Relevant Bleedings prior to day 90 +/-5.
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |