Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00246025
Other study ID # 1160.50
Secondary ID
Status Completed
Phase Phase 2
First received October 28, 2005
Last updated June 3, 2014
Start date October 2005

Study information

Verified date February 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 512
Est. completion date
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Drug:
Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Dabigatran Etexilate
Dabigatran etexilate 220 mg capsule, once a day, oral administration
placebo
matching placebo capsule, once a day, oral administration

Locations

Country Name City State
Japan 1160.50.001 Boehringer Ingelheim Investigational Site Eniwa, Hokkaido
Japan 1160.50.018 Boehringer Ingelheim Investigational Site Fukuoka, Fukuoka
Japan 1160.50.008 Boehringer Ingelheim Investigational Site Hachioji, Tokyo
Japan 1160.50.006 Boehringer Ingelheim Investigational Site Hirosaki, Aomori
Japan 1160.50.026 Boehringer Ingelheim Investigational Site Hiroshima, Hiroshima
Japan 1160.50.011 Boehringer Ingelheim Investigational Site Iida, Nagano
Japan 1160.50.024 Boehringer Ingelheim Investigational Site Izumisano, Osaka
Japan 1160.50.045 Boehringer Ingelheim Investigational Site Izunokuni,Shizuoka
Japan 1160.50.022 Boehringer Ingelheim Investigational Site Kagoshima, Kagoshima
Japan 1160.50.027 Boehringer Ingelheim Investigational Site Kawasaki, Kanagawa
Japan 1160.50.032 Boehringer Ingelheim Investigational Site Kawasaki, Kanagawa
Japan 1160.50.041 Boehringer Ingelheim Investigational Site Kitakyusyu, Fukuoka
Japan 1160.50.039 Boehringer Ingelheim Investigational Site Koshigaya,Saitama
Japan 1160.50.037 Boehringer Ingelheim Investigational Site Kurume ,Fukuoka
Japan 1160.50.038 Boehringer Ingelheim Investigational Site Kurume ,Fukuoka
Japan 1160.50.013 Boehringer Ingelheim Investigational Site Kyoto, Kyoto
Japan 1160.50.036 Boehringer Ingelheim Investigational Site Matsue, Shimane
Japan 1160.50.042 Boehringer Ingelheim Investigational Site Miyazaki, Miyazaki
Japan 1160.50.028 Boehringer Ingelheim Investigational Site Musashimurayama, Tokyo
Japan 1160.50.005 Boehringer Ingelheim Investigational Site Obihiro, Hokkaido
Japan 1160.50.030 Boehringer Ingelheim Investigational Site Okayama, Okayama
Japan 1160.50.021 Boehringer Ingelheim Investigational Site Omura, Nagasaki
Japan 1160.50.014 Boehringer Ingelheim Investigational Site Osaka, Osaka
Japan 1160.50.015 Boehringer Ingelheim Investigational Site Osaka, Osaka
Japan 1160.50.016 Boehringer Ingelheim Investigational Site Osaka, Osaka
Japan 1160.50.033 Boehringer Ingelheim Investigational Site Osaka, Osaka
Japan 1160.50.031 Boehringer Ingelheim Investigational Site Saga, Saga
Japan 1160.50.009 Boehringer Ingelheim Investigational Site Sagamihara, Kanagawa
Japan 1160.50.002 Boehringer Ingelheim Investigational Site Sapporo, Hokkaido
Japan 1160.50.004 Boehringer Ingelheim Investigational Site Sapporo, Hokkaido
Japan 1160.50.020 Boehringer Ingelheim Investigational Site Sasebo, Nagasaki
Japan 1160.50.025 Boehringer Ingelheim Investigational Site Sasebo, Nagasaki
Japan 1160.50.034 Boehringer Ingelheim Investigational Site Sendai, Miyagi
Japan 1160.50.029 Boehringer Ingelheim Investigational Site Shinjuku-ku,Tokyo
Japan 1160.50.043 Boehringer Ingelheim Investigational Site Shizuoka, Shizuoka
Japan 1160.50.044 Boehringer Ingelheim Investigational Site Sumida-ku, Tokyo
Japan 1160.50.023 Boehringer Ingelheim Investigational Site Tomigusuku, Okinawa
Japan 1160.50.040 Boehringer Ingelheim Investigational Site Tsukuba , Ibaraki

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period. number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality 2 weeks study medication No
Secondary Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality 2 weeks No
Secondary Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period Number of participants who have Proximal DVT during treatment period 2 weeks No
Secondary Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis) Number of Participants expressing DVT with symptoms 2 weeks No
Secondary Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period Number of participants who have Total DVT during treatment period 2 weeks No
Secondary Number of Participants With Pulmonary Embolism During Treatment Period Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT. 2 weeks No
Secondary Number of Participants Who Died During Treatment Period All cause death, as adjudicated by the VTE events committee. 2 weeks No
Secondary Number of Participants With Bleeding Events During Treatment Period Major bleeding events were defined as
fatal
clinically overt associated with loss of haemoglobin >=2g/dL in excess of what was expected
clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
symptomatic retroperitoneal, intracranial, intraocular or intraspinal
requiring treatment cessation
leading to re-operation
Clinically-relevant was defined as
spontaneous skin hematoma >=25 cm²
wound hematoma >=100 cm²
spontaneous nose bleed >5 min
macroscopic hematuria spontaneous or >24 hours if associated with an intervention
spontaneous rectal bleeding (more than a spot on toilet paper)
gingival bleeding >5 min
any other bleeding event considered clinically relevant by the investigator
Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
2 weeks Yes
Secondary Blood Transfusion Blood transfusion for treated and operated patients on Day of surgery. Day 0 No
Secondary Volume of Blood Loss Volume of blood loss for treated and operated patients during surgery. Day 0 No
Secondary Laboratory Analyses Frequency of patients with possible clinically significant abnormalities. First administration to end of study No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Recruiting NCT05002387 - Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis N/A
Recruiting NCT06080763 - Biomechanics and Clinical Outcomes in Responders and Non-Responders
Completed NCT03008967 - A Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark N/A
Withdrawn NCT02255877 - ZIPS Study - Zip Incision Approximation vs. STAPLE Phase 4
Completed NCT02642731 - Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty N/A
Completed NCT02525588 - Polyethylene Wear Study on the Triathlon Total Knee Prosthesis N/A
Completed NCT01799772 - The Feasibility of a Comprehensive Behavioral Intervention in Patient Post TKA Phase 1/Phase 2
Completed NCT02520531 - Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty N/A
Completed NCT03183856 - Comparison of Ambulatory and Functional Improvement by Morning Walk N/A
Completed NCT03569397 - Music Therapy Versus Control for Total Knee Arthroplasty N/A
Terminated NCT02711592 - Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study N/A
Completed NCT03145493 - Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid N/A
Terminated NCT05602701 - Preoperative Prediction of Postoperative Physical Function
Recruiting NCT03570944 - Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER2)
Completed NCT02773537 - Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial N/A
Withdrawn NCT02553122 - The Combined Efficacy of Evicel and Tranexamic Acid on Total Knee Arthroplasty Phase 3
Recruiting NCT02385383 - An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study N/A
Completed NCT02121392 - Epidural Catheter With or Without Adductor Canal Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty N/A
Terminated NCT02155712 - Triathlon Tritanium Knee Outcomes Study N/A

External Links