Venous ThromboembolismPhase 2/3NCT00917254
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
A Phase 2/3 study testing YM150 and Enoxaparin in people with Venous Thromboembolism, run by Astellas Pharma Inc at 13 sites in 3 countries.
Trial summary
The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- YM150 and Enoxaparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 13 sitesin 3 countries
- Study dates
- May 2009to Jan 2010
- Phase
- Phase 2/3
- 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
- Subjects is scheduled for elective primary total knee replacement surgery
- Written informed consent obtained before screening
Who cannot join
- Subject has history of deep vein thrombosis and/or pulmonary embolism
- Subject has a hemorrhagic disorder and/or coagulation disorder
- Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
- Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia
- Subject is receiving anticoagulants/antiplatelets
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Japan7 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyusyu
Study site
Tōhoku
Taiwan4 sites
Study site
Changhua
Study site
Chiayi City
Study site
Kaohsiung City
Study site
Taichung
About this study
Official title: Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Knee Replacement Surgery -
The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.
- Conditions
- Venous Thromboembolism
- Being tested
- YM150, Placebo, Enoxaparin
- Keywords
- YM150, Thrombosis, VTE, Knee Replacement, Anticoagulant, FXa inhibitor
- Medical subject headings
- Venous Thromboembolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM150Drug
oral
PlaceboDrug
oral
EnoxaparinDrug
injection
| Study group | Role | What they receive |
|---|---|---|
| YM150 group-1 | Experimental | YM150 low dose group Receives: Drug: YM150 |
| YM150 group-2 | Experimental | YM150 high dose group Receives: Drug: YM150 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
| Enoxaparin group | Active comparator | Not described Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of venous thromboembolism
Measured: 2 weeks
Secondary outcomes (2)
Incidence of individual venous thromboembolism
Measured: 2 weeks
Incidence of bleeding events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2010
- Study completionJan 2010
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.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917254
- Sponsor's protocol ID
- 150-CL-031
- Status last verified
- Jun 2010
- First submitted
- 8 Jun 2009
- Last updated
- 16 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Knee Replacement Surgery -
- ClinicalTrials.gov ID
- NCT00917254
- Acronym / sponsor ID
- 150-CL-031
- Conditions
- Venous Thromboembolism
- Keywords
- YM150, Thrombosis, VTE, Knee Replacement, Anticoagulant, FXa inhibitor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 Jun 2009 (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.
The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YM150 group-1 | Experimental | Drug: YM150YM150 low dose group |
| YM150 group-2 | Experimental | Drug: YM150YM150 high dose group |
| Placebo group | Placebo comparator | Drug: Placebo |
| Enoxaparin group | Active comparator | Drug: Enoxaparin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects is scheduled for elective primary total knee replacement surgery
- Written informed consent obtained before screening
Key exclusion criteria (5 listed)
- Subject has history of deep vein thrombosis and/or pulmonary embolism
- Subject has a hemorrhagic disorder and/or coagulation disorder
- Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
- Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia
- Subject is receiving anticoagulants/antiplatelets
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 |
|---|---|---|
| YM150oral | Drug | YM150 group-1, YM150 group-2 |
| Placebooral | Drug | Placebo group |
| Enoxaparininjection | Drug | Enoxaparin group |
Primary outcome
Overall incidence of venous thromboembolism
Time frame: 2 weeks
2 secondary outcomes
Incidence of individual venous thromboembolism
Time frame: 2 weeks
Incidence of bleeding events
Time frame: 2 weeks
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 16 Jun 2010.
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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.
Use Central Contact study chair
Astellas Pharma Inc
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing YM150 and Enoxaparin in people with Venous Thromboembolism, run by Astellas Pharma Inc at 13 sites in 3 countries.
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 2 inclusion and 5 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 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan, Taiwan, Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Overall incidence of venous thromboembolism (time frame: 2 weeks). 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 16 Jun 2010.