Arthroplasty, Replacement, HipPhase 3NCT00349180
Total Hip Replacement Study With XRP4563 (Enoxaparin Sodium)
A Phase 3 study testing Enoxaparin sodium in people with Arthroplasty, Replacement, Hip, run by Sanofi at 1 site in Japan.
Trial summary
This study is performed to confirm the optimal dose for THR (total hip replacement). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Enoxaparin sodium
- How many people
- 156 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective primary THR (total hip replacement) surgery
Who cannot join
- Patient with risk of clinical significant bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium（RP54563）20mg qd and 20mg Bid for 14 Days in Patients With Total Hip Replacement
This study is performed to confirm the optimal dose for THR (total hip replacement).
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Enoxaparin sodium
- Keywords
- Total Hip Replacement, Enoxaparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of VTE
Secondary outcomes (1)
Incidence of bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 156 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yoshihiro IKEDA, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349180
- Sponsor's protocol ID
- EFC6770
- Status last verified
- Mar 2009
- First submitted
- 4 Jul 2006
- Last updated
- 27 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium（RP54563）20mg qd and 20mg Bid for 14 Days in Patients With Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00349180
- Acronym / sponsor ID
- EFC6770
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Total Hip Replacement, Enoxaparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- First posted
- 6 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is performed to confirm the optimal dose for THR (total hip replacement).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective primary THR (total hip replacement) surgery
Key exclusion criteria (1 listed)
- Patient with risk of clinical significant bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin sodium | Drug | – |
Primary outcome
Incidence of VTE
1 secondary outcome
Incidence of bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshihiro IKEDA study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enoxaparin sodium in people with Arthroplasty, Replacement, Hip, run by Sanofi at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of VTE. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2009.