ARIXTRA Local Study For Registration In China.
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00328939
First received: May 22, 2006
Last updated: May 31, 2012
Last verified: February 2011
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Purpose
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 |
|---|---|---|
|
Thromboembolism Knee Replacement Hip Replacement |
Drug: ARIXTRA infusion Drug: Enoxaparine infusion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
| 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. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
Secondary Outcome Measures:
- Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2004 |
Intervention Details:
-
Drug: ARIXTRA infusion
Drug: Enoxaparine infusion
- Enoxaparine infusion
- ARIXTRA infusion
Other Names:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients undergoing either an elective major hip or knee replacement or revision.
- Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child.
Exclusion criteria:
- History of serious active bleeding in last 3 month
- Concurrent or history of thrombocytopenia ( Platelet< 100x109/L)
- History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product
- Acute bacterial endocarditis
- Congenital or acquired bleeding disease in last 3 months
- Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia
- Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye
- Conditions need to leave a tubule in intradural or extradural
- Contraindication to anticoagulant or condition required to take long term oral anticoagulant
- Abnormality in hepatic (>1.5x UNL), renal (Clcr < 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb
- Positive result in Human Chorionic Gonadotropin test Participated in any other investigational study on Deep Vein Thrombosis prevention in last 90 days.
- Concurrently to have hip and knee or double hip/knee replacement at the same time
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328939
Locations
| 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 | |
| China | |
| GSK Investigational Site | |
| Beijing, China, 100044 | |
| GSK Investigational Site | |
| Shanghai, China, 200025 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00328939 History of Changes |
| Other Study ID Numbers: | ITI105316 |
| Study First Received: | May 22, 2006 |
| Last Updated: | May 31, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
ARIXTRA prevention of DVT |
Additional relevant MeSH terms:
|
Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Fondaparinux PENTA Enoxaparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013