Conditions: Venous Thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1973
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 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 arm 2: 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 arm 3: 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 arm 4: 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 arm 5: placebo matching BIBR 1048 0 mg twice a day plus enoxaparin 40 mg s.c once a day for the treatment period

Interventions: intervention 1: Enoxaparin intervention 2: BIBR 1048 intervention 3: BIBR 1048 intervention 4: BIBR 1048 intervention 5: BIBR 1048
Intervention descriptions: intervention 1: Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period intervention 2: 50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period intervention 3: 150 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period intervention 4: 225 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period intervention 5: 300 mg q.d BIBR 1048 capsule for 5-10 treatment period

Protocol document: