A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
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 preventi on of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.
Description
This is a double-blind, multi-centre, randomized, parallel-group placebo-controlled study to evaluat e the efficacy and safety of BIBR 1048 (Dabigatran etexilate) oral administration, as well as its do se-response, in preventing venous thromboembolism (deep vein thrombosis and pulmonary embolism) in p atients with elective total knee replacement surgery. There are three administration groups in total
, the BIBR 1048 110 mg, 150 mg and 220 mg once daily administration groups and the placebo group, wi th 100 cases in each group (total of 400 cases), and the study drug will be randomly allocated to pa tients in each group. The administration period is 11-14 days after total knee replacement surgery, and the study drug will be given once daily.
Study Hypothesis:
This trial aims is to demonstrate the effectiveness of BIBR 1048 (Dabigatran ete xilate), compared with placebo, in prevention of venous thromboembolism in patie nts with primary elective total knee replacement surgery. For the primary endpoi nt (total VTE and all cause mortality), superiority of BIBR 1048 (Dabigatran ete xilate) to placebo will be tested.
Comparison(s):
For the primary comparison the rates of total venous thromboemobolism events (VT E) and all-cause mortality during the treatment period will be compared.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Conditions
Arthroplasty, Replacement, Knee
Intervention
110 mg capsule (110 mg capsule + placebo capsule), 150 mg capsule (75 mg capsule x 2), 220 mg capsule (110 mg capsule x 2)
Location
Boehringer Ingelheim Investigational Site
Eniwa, Hokkaido
Japan
061-1308
Status
Completed
Source
Boehringer Ingelheim Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00246025
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Capsule Opacification
Clouding or loss of transparency of the posterior lens capsule, usually following CATARACT extraction.
Capsule Endoscopy
Non-invasive, endoscopic imaging by use of VIDEO CAPSULE ENDOSCOPES to perform examination of the gastrointestinal tract, especially the small bowel.
Capsule Endoscopes
A pill sized videocamera encased in a capsule. It is designed to be swallowed and subsequently traverse the gastrointestinal tract while transmitting diagnostic images along the way.
Joint Capsule
The sac enclosing a joint. It is composed of an outer fibrous articular capsule and an inner SYNOVIAL MEMBRANE.
Joint Capsule Release
Surgical procedure to relax the JOINT CAPSULE tissues in a joint that has a reduced range of motion due to CONTRACTURE or TISSUE ADHESIONS or joint deformities.
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