A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Arthroplasty, Replacement, Knee; Venous Thrombosis

Treatments: Drug: Dabigatran etexilate; Drug: Dabigatran Etexilate; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00246025

1160.50

Details and patient eligibility

About

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

Enrollment: 512 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria Inclusion criteria

1. Patients scheduled to undergo a primary, unilateral elective total knee replacement
2. Male or Female 20 years of age or order
3. Patients weighing at least 40 kg
4. Written informed consent prior to the start of study participation

Exclusion criteria Exclusion criteria

1. History of bleeding diathesis
2. Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding
3. Major surgery or trauma (e.g. hip fracture) within the last 3 months
4. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months
5. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV (arteriovenous) malformation or aneurysm or recent bleeding history
6. Condition requiring anti-coagulant therapy
7. Elevated AST(Aspartate Aminotransferase) , ALT(Alanine Aminotransferase), or any history of clinically relevant liver disease
8. Patients with a history of clinically significant renal diseases or with elevated creatinine values

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

512 participants in 4 patient groups, including a placebo group

Dabigatran etexilate 110 mg

Experimental group

Description:

Dabigatran etexilate 110 mg capsule, once a day, oral administration

Treatment:

Drug: Dabigatran etexilate

Drug: Dabigatran etexilate

Dabigatran etexilate 150 mg

Experimental group

Description:

Dabigatran etexilate 150 mg capsule, once a day, oral administration

Treatment:

Drug: Dabigatran etexilate

Drug: Dabigatran etexilate

Dabigatran etexilate 220 mg

Experimental group

Description:

Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration

Treatment:

Drug: Dabigatran Etexilate

Placebo

Placebo Comparator group

Description:

matching placebo capsule, once a day, oral administration

Treatment:

Drug: placebo