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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 1048 | Experimental | Ascending doses (in mg) given twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 | Drug | Ascending doses (in mg) given twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of venous thrombolic events | Up to day 10 after hip surgery | |
| Changes from baseline in activated partial thromboplastin time (aPTT) | From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10) | |
| Changes from baseline in ecarin clotting time (ECT) | From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10) | |
| Changes from baseline in thrombin time (TT) | From baseline (day -14 to day -1 before treatment) until last day of treatment (up to day 10) | |
| Rate of major bleeding events during treatment phase | Start of treatment (day 0) until end of treatment (up to day 10) | |
| Cpre,ss (predose plasma concentrations at steady state) | baseline and predose from day 1 to last treatment day | |
| Cmax,ss (maximum plasma concentration at steady state (day 4)) | Day 4 | |
| Tmax,ss (time to reach Cmax,ss) | baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment | |
| CLtot/f (total clearance of drug from plasma after oral administration) | baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Venous thromboembolism diagnosed during the follow-up period | Up to 6 weeks after surgery (day 42) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| AUCss (area under the plasma concentration curve of one dosing interval at steady state) | baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment |
| PTF (percent peak trough fluctuation for the last dosing interval) | baseline, day 0 before and 4 hours after, day 1 to 4 before and 2 h after treatment, day 5 to last treatment day before treatment |
| Cmax,ss (maximum plasma concentration at steady state (day 4)) | Day 4 before and 0.5, 1, 2, 4 , 8, 12 , 14 h after treatment |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |