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

NCT ID: NCT00246025

Last Updated: 2014-06-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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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.

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A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

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Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate

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Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)

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Detailed Description

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Conditions

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Arthroplasty, Replacement, Knee Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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Dabigatran etexilate 110 mg

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

Group Type EXPERIMENTAL

Dabigatran etexilate

Intervention Type DRUG

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

Dabigatran etexilate 150 mg

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

Group Type EXPERIMENTAL

Dabigatran etexilate

Intervention Type DRUG

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

Dabigatran etexilate 220 mg

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

Group Type EXPERIMENTAL

Dabigatran Etexilate

Intervention Type DRUG

Dabigatran etexilate 220 mg capsule, once a day, oral administration

Placebo

matching placebo capsule, once a day, oral administration

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

matching placebo capsule, once a day, oral administration

Interventions

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Dabigatran etexilate

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

Intervention Type DRUG

Dabigatran etexilate

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

Intervention Type DRUG

Dabigatran Etexilate

Dabigatran etexilate 220 mg capsule, once a day, oral administration

Intervention Type DRUG

placebo

matching placebo capsule, once a day, oral administration

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.50.001 Boehringer Ingelheim Investigational Site

Eniwa, Hokkaido, , Japan

Site Status

1160.50.018 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

Site Status

1160.50.008 Boehringer Ingelheim Investigational Site

Hachioji, Tokyo, , Japan

Site Status

1160.50.006 Boehringer Ingelheim Investigational Site

Hirosaki, Aomori, , Japan

Site Status

1160.50.026 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, , Japan

Site Status

1160.50.011 Boehringer Ingelheim Investigational Site

Iida, Nagano, , Japan

Site Status

1160.50.024 Boehringer Ingelheim Investigational Site

Izumisano, Osaka, , Japan

Site Status

1160.50.045 Boehringer Ingelheim Investigational Site

Izunokuni,Shizuoka, , Japan

Site Status

1160.50.022 Boehringer Ingelheim Investigational Site

Kagoshima, Kagoshima, , Japan

Site Status

1160.50.027 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, , Japan

Site Status

1160.50.032 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, , Japan

Site Status

1160.50.041 Boehringer Ingelheim Investigational Site

Kitakyusyu, Fukuoka, , Japan

Site Status

1160.50.039 Boehringer Ingelheim Investigational Site

Koshigaya,Saitama, , Japan

Site Status

1160.50.037 Boehringer Ingelheim Investigational Site

Kurume ,Fukuoka, , Japan

Site Status

1160.50.038 Boehringer Ingelheim Investigational Site

Kurume ,Fukuoka, , Japan

Site Status

1160.50.013 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

Site Status

1160.50.036 Boehringer Ingelheim Investigational Site

Matsue, Shimane, , Japan

Site Status

1160.50.042 Boehringer Ingelheim Investigational Site

Miyazaki, Miyazaki, , Japan

Site Status

1160.50.028 Boehringer Ingelheim Investigational Site

Musashimurayama, Tokyo, , Japan

Site Status

1160.50.005 Boehringer Ingelheim Investigational Site

Obihiro, Hokkaido, , Japan

Site Status

1160.50.030 Boehringer Ingelheim Investigational Site

Okayama, Okayama, , Japan

Site Status

1160.50.021 Boehringer Ingelheim Investigational Site

Omura, Nagasaki, , Japan

Site Status

1160.50.014 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1160.50.015 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1160.50.016 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1160.50.033 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1160.50.031 Boehringer Ingelheim Investigational Site

Saga, Saga, , Japan

Site Status

1160.50.009 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, , Japan

Site Status

1160.50.002 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1160.50.004 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1160.50.020 Boehringer Ingelheim Investigational Site

Sasebo, Nagasaki, , Japan

Site Status

1160.50.025 Boehringer Ingelheim Investigational Site

Sasebo, Nagasaki, , Japan

Site Status

1160.50.034 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, , Japan

Site Status

1160.50.029 Boehringer Ingelheim Investigational Site

Shinjuku-ku,Tokyo, , Japan

Site Status

1160.50.043 Boehringer Ingelheim Investigational Site

Shizuoka, Shizuoka, , Japan

Site Status

1160.50.044 Boehringer Ingelheim Investigational Site

Sumida-ku, Tokyo, , Japan

Site Status

1160.50.023 Boehringer Ingelheim Investigational Site

Tomigusuku, Okinawa, , Japan

Site Status

1160.50.040 Boehringer Ingelheim Investigational Site

Tsukuba , Ibaraki, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1160.50

Identifier Type: -

Identifier Source: org_study_id

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