BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Enoxaparin

Criteria

Inclusion criteria

1. Patients scheduled to undergo a primary elective total hip or knee replacement.

2. Male of female being 18 years or older.

3. Patients weighing at least 40 kg.

4. Written informed consent for study participation.

Exclusion criteria

1. Bleeding diathesis, constitutional or acquired coagulation disorders.

2. Major surgery or trauma(e.g., hip fracture) within the last 3 months.

3. Cardiovascular disease

4. Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks lasting more than 24 hours and / or with cardiovascular pathological findings.

5. Deep vein thrombosis(DVT), gastrointestinal or pulmonary bleeding, gastric or duodenal ulcer within the last year.

6. History of or acute intracranial disease

7. Liver disease

8. Renal disease

9. Use of long-term anticoagulants or antiplatelet drugs within 7 days prior to hip/knee replacement operation.

10. Pre-menopausal women who are not surgically steriles, are nursing and are of child-bearing potential and are not practising acceptable methods of birth control

11. Known allergy to contrast media

12. Thrombocytopenia

13. Allergy against heparin.

14. Active malignant disease or current cytostatic treatment.

15. Treatment with an investigational drug in the past month.

16. Leg amputee

17. Known alcohol or drug abuse