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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: Enoxaparin; Drug: BIBR 1048

Study type: Interventional

Funder types: Industry

Identifiers

NCT01225822

1160.19

Details and patient eligibility

About

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.

Enrollment: 1,973 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,973 participants in 5 patient groups

BIBR 1048 50 mg bis in die(b.i.d)

Experimental group

Description:

BIBR 1048 50 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus one placebo matching enoxaparin 0 mg once a day for the treatment period

Treatment:

Drug: BIBR 1048

Drug: BIBR 1048

Drug: BIBR 1048

Drug: BIBR 1048

BIBR 1048 150 mg b.i.d

Experimental group

Description:

BIBR 1048 150 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period

Treatment:

Drug: BIBR 1048

Drug: BIBR 1048

Drug: BIBR 1048

Drug: BIBR 1048

BIBR 1048 225 mg b.i.d

Experimental group

Description:

BIBR 1048 225 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period

Treatment:

Drug: BIBR 1048

Drug: BIBR 1048

Drug: BIBR 1048

Drug: BIBR 1048

BIBR 1048 300 mg quaque die(q.d)

Experimental group

Description:

BIBR 1048 150 mg q.d once a day plus placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period

Treatment:

Drug: BIBR 1048

Drug: BIBR 1048

Drug: BIBR 1048

Drug: BIBR 1048

Enoxaparin 40 mg subcutaneous(s.c)

Active Comparator group

Description:

placebo matching BIBR 1048 0 mg twice a day plus enoxaparin 40 mg s.c once a day for the treatment period

Treatment:

Drug: Enoxaparin