ThromboembolismPhase 2PEARL-1NCT00408239
Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
A Phase 2 study testing YM150 and enoxaparin in people with Thromboembolism, run by Astellas Pharma Inc at 19 sites in 8 countries.
Trial summary
Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolism
- What is being tested?
- YM150 and enoxaparin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 19 sitesin 8 countries
- Study dates
- Dec 2006to Mar 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective primary total knee replacement surgery
- Legal minimum age requirement ( country-specific)
- Written informed consent has been obtained
Who cannot join
- Documented history or considered to be at increased risk of venous thromboembolism
- Subjects considered to be at increased risk of bleeding:
- Known hemorrhagic disorder and/or coagulation disorder
- Thrombocytopenia
- Clinically important bleeding occurred within 3 months prior to the screening visit
- Acute bacterial endocarditis
Show all 9Show fewer
- Severe hypertension
- Retinopathy
- Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Japan7 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Kansai Region
Study site
Kanto Region
Study site
Kyushyu Region
Study site
Shikoku Region
Study site
Tohoku Region
South Korea3 sites
Study site
Incheon, 405-760
Study site
Jeonnam, 519-809
Study site
Seoul, 110-744
About this study
Official title: Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-controlled, Open Label, Dose-escalation Study
Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery
- Conditions
- Thromboembolism
- Being tested
- YM150, enoxaparin
- Keywords
- Factor Xa inhibitor, Thromboembolism, Arthroplasty, Knee Replacement, Prevention and Control
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM150Drug
Oral
enoxaparinDrug
Sub cutaneous
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose regimen 1 Receives: Drug: YM150 |
| 2 | Active comparator | Not described Receives: Drug: enoxaparin |
| 3 | Experimental | Dose regimen 2 Receives: Drug: YM150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment
Measured: 2 Weeks
Secondary outcomes (3)
Venous thromboembolism and/or bleeds
Measured: 2 Weeks
Other safety assessments
Measured: 2 Weeks
PK, PD variables
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 posted6 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408239
- Sponsor's protocol ID
- 150-CL-029
- Acronym
- PEARL-1
- Status last verified
- Dec 2011
- First submitted
- 4 Dec 2006
- Last updated
- 19 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-controlled, Open Label, Dose-escalation Study
- ClinicalTrials.gov ID
- NCT00408239
- Acronym / sponsor ID
- PEARL-1 / 150-CL-029
- Conditions
- Thromboembolism
- Keywords
- Factor Xa inhibitor, Thromboembolism, Arthroplasty, Knee Replacement, Prevention and Control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Dec 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.
Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: YM150Dose regimen 1 |
| 2 | Active comparator | Drug: enoxaparin |
| 3 | Experimental | Drug: YM150Dose regimen 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for elective primary total knee replacement surgery
- Legal minimum age requirement ( country-specific)
- Written informed consent has been obtained
Key exclusion criteria (9 listed)
- Documented history or considered to be at increased risk of venous thromboembolism
- Subjects considered to be at increased risk of bleeding:
- Acute bacterial endocarditis
- Severe hypertension
- Retinopathy
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 | 1, 3 |
| enoxaparinSub cutaneous | Drug | 2 |
Primary outcome
All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment
Time frame: 2 Weeks
3 secondary outcomes
Venous thromboembolism and/or bleeds
Time frame: 2 Weeks
Other safety assessments
Time frame: 2 Weeks
PK, PD variables
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 19 Dec 2011.
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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.
Central Contact study chair
Astellas Pharma Inc
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM150 and enoxaparin in people with Thromboembolism, run by Astellas Pharma Inc at 19 sites in 8 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 3 inclusion and 9 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan, South Korea, Malaysia, Philippines, Thailand and 3 more countries. 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 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?
All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment (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 19 Dec 2011.