Clinical trial NCT00246025: A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
Official title: A Randomised, Parallel-group, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthroplasty, Replacement, Knee
Venous Thrombosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-10-30
Enrollment: 512
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.
timeFrame: 2 weeks study medication
Secondary outcomes:
measure: Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality
timeFrame: 2 weeks
measure: Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period
timeFrame: 2 weeks
measure: Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)
timeFrame: 2 weeks
measure: Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period
timeFrame: 2 weeks
measure: Number of Participants With Pulmonary Embolism During Treatment Period
timeFrame: 2 weeks
measure: Number of Participants Who Died During Treatment Period
timeFrame: 2 weeks
measure: Number of Participants With Bleeding Events During Treatment Period
timeFrame: 2 weeks
measure: Blood Transfusion
timeFrame: Day 0
measure: Volume of Blood Loss
timeFrame: Day 0
measure: Laboratory Analyses
timeFrame: First administration to end of study
Other outcomes:
Locations:
city: Eniwa, Hokkaido
country: Japan
facility: 1160.50.001 Boehringer Ingelheim Investigational Site
city: Fukuoka, Fukuoka
country: Japan
facility: 1160.50.018 Boehringer Ingelheim Investigational Site
city: Hachioji, Tokyo
country: Japan
facility: 1160.50.008 Boehringer Ingelheim Investigational Site
city: Hirosaki, Aomori
country: Japan
facility: 1160.50.006 Boehringer Ingelheim Investigational Site
city: Hiroshima, Hiroshima
country: Japan
facility: 1160.50.026 Boehringer Ingelheim Investigational Site
city: Iida, Nagano
country: Japan
facility: 1160.50.011 Boehringer Ingelheim Investigational Site
city: Izumisano, Osaka
country: Japan
facility: 1160.50.024 Boehringer Ingelheim Investigational Site
city: Izunokuni,Shizuoka
country: Japan
facility: 1160.50.045 Boehringer Ingelheim Investigational Site
city: Kagoshima, Kagoshima
country: Japan
facility: 1160.50.022 Boehringer Ingelheim Investigational Site
city: Kawasaki, Kanagawa
country: Japan
facility: 1160.50.027 Boehringer Ingelheim Investigational Site
city: Kawasaki, Kanagawa
country: Japan
facility: 1160.50.032 Boehringer Ingelheim Investigational Site
city: Kitakyusyu, Fukuoka
country: Japan
facility: 1160.50.041 Boehringer Ingelheim Investigational Site
city: Koshigaya,Saitama
country: Japan
facility: 1160.50.039 Boehringer Ingelheim Investigational Site
city: Kurume ,Fukuoka
country: Japan
facility: 1160.50.037 Boehringer Ingelheim Investigational Site
city: Kurume ,Fukuoka
country: Japan
facility: 1160.50.038 Boehringer Ingelheim Investigational Site
city: Kyoto, Kyoto
country: Japan
facility: 1160.50.013 Boehringer Ingelheim Investigational Site
city: Matsue, Shimane
country: Japan
facility: 1160.50.036 Boehringer Ingelheim Investigational Site
city: Miyazaki, Miyazaki
country: Japan
facility: 1160.50.042 Boehringer Ingelheim Investigational Site
city: Musashimurayama, Tokyo
country: Japan
facility: 1160.50.028 Boehringer Ingelheim Investigational Site
city: Obihiro, Hokkaido
country: Japan
facility: 1160.50.005 Boehringer Ingelheim Investigational Site
city: Okayama, Okayama
country: Japan
facility: 1160.50.030 Boehringer Ingelheim Investigational Site
city: Omura, Nagasaki
country: Japan
facility: 1160.50.021 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1160.50.014 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1160.50.015 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1160.50.016 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1160.50.033 Boehringer Ingelheim Investigational Site
city: Saga, Saga
country: Japan
facility: 1160.50.031 Boehringer Ingelheim Investigational Site
city: Sagamihara, Kanagawa
country: Japan
facility: 1160.50.009 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1160.50.002 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1160.50.004 Boehringer Ingelheim Investigational Site
city: Sasebo, Nagasaki
country: Japan
facility: 1160.50.020 Boehringer Ingelheim Investigational Site
city: Sasebo, Nagasaki
country: Japan
facility: 1160.50.025 Boehringer Ingelheim Investigational Site
city: Sendai, Miyagi
country: Japan
facility: 1160.50.034 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku,Tokyo
country: Japan
facility: 1160.50.029 Boehringer Ingelheim Investigational Site
city: Shizuoka, Shizuoka
country: Japan
facility: 1160.50.043 Boehringer Ingelheim Investigational Site
city: Sumida-ku, Tokyo
country: Japan
facility: 1160.50.044 Boehringer Ingelheim Investigational Site
city: Tomigusuku, Okinawa
country: Japan
facility: 1160.50.023 Boehringer Ingelheim Investigational Site
city: Tsukuba , Ibaraki
country: Japan
facility: 1160.50.040 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: