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.


Read more »

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

See more »

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
Terminated NCT02155712 - Triathlon Tritanium Knee Outcomes Study N/A
Completed NCT02121392 - Epidural Catheter With or Without Adductor Canal Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty N/A

External Links