Venous ThromboembolismPhase 2NCT00541320
Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)
A Phase 2 study testing GW813893 in people with Venous Thromboembolism, run by GlaxoSmithKline at 8 sites in United States.
Trial summary
This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- GW813893
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2007to not given
- Phase
- Phase 2
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled for primary elective unilateral total knee arthroplasty.
Who cannot join
- Women who are not surgically sterile or post-menopausal
- Have a contra-indication to contract venography
- Have a known disorder associated with increased risk of bleeding or have been immobile up to 12 weeks before surgery.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
GSK Clinical Trials Call Center
Birmingham, Alabama, 35209
GSK Clinical Trials Call Center
Charleston, South Carolina, 29414
GSK Clinical Trials Call Center
Decatur, Georgia, 30032
GSK Clinical Trials Call Center'
Phoenix, Arizona, 85023
GSK Clinical Trials Call Center
Phoenix, Arizona, 85023
GSK Clinical Trials Call Center
San Antonio, Texas, 78217
GSK Clinical Trials Call Center
St. Petersburg, Florida, 33703
GSK Clinical Trials Call Center
Yuba City, California, 95991
About this study
Official title: Dose Ranging Trial for the Evaluation of the Safety and Efficacy of GW813893 in the Prophylaxis of Venous Thromboembolism Post Total Knee Replacement Surgery.
This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation.
- Conditions
- Venous Thromboembolism
- Being tested
- GW813893
- Keywords
- Anti-thrombolytic direct Factor Xa inhibitor
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW813893Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.
Measured: symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.
Secondary outcomes (1)
Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery.
Measured: Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startFeb 2007
Why it stopped: No longer viable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541320
- Sponsor's protocol ID
- FTI102595
- Status last verified
- Apr 2013
- First submitted
- 12 Feb 2007
- Last updated
- 4 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Ranging Trial for the Evaluation of the Safety and Efficacy of GW813893 in the Prophylaxis of Venous Thromboembolism Post Total Knee Replacement Surgery.
- ClinicalTrials.gov ID
- NCT00541320
- Acronym / sponsor ID
- FTI102595
- Conditions
- Venous Thromboembolism
- Keywords
- Anti-thrombolytic direct Factor Xa inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer viable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- First posted
- 10 Oct 2007 (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 was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are scheduled for primary elective unilateral total knee arthroplasty.
Key exclusion criteria (3 listed)
- Women who are not surgically sterile or post-menopausal
- Have a contra-indication to contract venography
- Have a known disorder associated with increased risk of bleeding or have been immobile up to 12 weeks before surgery.
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 |
|---|---|---|
| GW813893 | Drug | – |
Primary outcome
Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.
Time frame: symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.
1 secondary outcome
Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery.
Time frame: Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW813893 in people with Venous Thromboembolism, run by GlaxoSmithKline at 8 sites in United States.
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 3 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: withdrawn, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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 death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery. (time frame: symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.). 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 4 Apr 2013.