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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00328939 |
This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.
Condition | Intervention | Phase |
---|---|---|
Hip Replacement Knee Replacement |
Drug: ARIXTRA infusion Drug: Enoxaparine infusion |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Single Blind, Parallel Study to Compare the Safety and Efficacy of ARIXTRA to Enoxaparine in Patients Undergoing Elective Major Hip or Knee Replacement or a Revision of Components. |
Estimated Enrollment: | 240 |
Study Start Date: | May 2004 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
China | |
GSK Investigational Site | |
Beijing, China, 100044 | |
GSK Investigational Site | |
Shanghai, China, 200025 | |
China, Henan | |
GSK Investigational Site | |
Zhengzhou, Henan, China, 450052 | |
China, Shaanxi | |
GSK Investigational Site | |
Xi'an, Shaanxi, China, 710032 | |
China, Shandong | |
GSK Investigational Site | |
Qingdao, Shandong, China, 266001 | |
China, Sichuan | |
GSK Investigational Site | |
Chengdu, Sichuan, China, 610041 | |
China, Zhejiang | |
GSK Investigational Site | |
Hangzhou, Zhejiang, China, 310009 |
Study Director: | GSK Clinical Trials, PhD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ITI105316, L-8541 |
Study First Received: | May 22, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00328939 History of Changes |
Health Authority: | China: State Food and Drug Administration |
ARIXTRA prevention of DVT |
Fibrin Modulating Agents Anticoagulants Fibrinolytic Agents Fondaparinux |
Cardiovascular Agents Org 31540 Enoxaparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents Fibrinolytic Agents |
Fondaparinux Cardiovascular Agents Pharmacologic Actions Org 31540 Enoxaparin |