Last updated: 11/04/2018 08:28:23
ARIXTRA Local Study For Registration In China.
GSK study ID
ITI105316
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: ARIXTRA infusion
Drug: Enoxaparine infusion
Enrollment:
240
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Thromboembolism, Knee Replacement
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
May 2004 to December 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Patients undergoing either an elective major hip or knee replacement or revision.
- Signed written informed consent.
- History of serious active bleeding in last 3 month
- Concurrent or history of thrombocytopenia ( Platelet< 100x109/L)
Inclusion and exclusion 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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-19-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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