ThromboembolismPhase 2NCT00353678
Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)
A Phase 2 study testing YM150 in people with Thromboembolism, run by Astellas Pharma Inc at 79 sites in 17 countries.
Trial summary
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip 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
- How many people
- 1,141 participants
- Where
- 79 sitesin 17 countries
- Study dates
- Jun 2006to Aug 2007
- 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 hip replacement
- Age 18 years or over
- Written informed consent obtained
Who cannot join
- Documented history or considered at increased risk of venous thromboembolism
- Subjects considered at increased risk of bleeding
- Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment
- Concomitant use of anticoagulants/ antiplatelet agents
Trial locations and contacts
79 sites in 17 countries.
79 sites in 17 countries
Russia11 sites
Study site
Chelyabinsk, 454026
Study site
Moscow, 111539
Study site
Moscow, 117869
Study site
Moscow, 119049
Study site
Moscow, 129327
Study site
Nizhny Novgorod, 603155
Study site
Orenburg, 460000
Study site
Saint Petersburg, 194291
Study site
Saint Petersburg, 195067
Study site
Samara, 443095
Study site
Volgograd, 400040
Italy10 sites
Study site
Bologna, 40136
Study site
Milan, 20123
Study site
Milan, 20162
Study site
Parma, 43100
Study site
Pavia, 27100
Study site
Pietra Ligure, 17027
Study site
Reggio Emilia, 42100
Study site
Rozzano, 20089
Study site
S. Donato Milanese, 20097
Study site
Udine, 33100
Spain8 sites
Study site
Cáceres, 10003
Study site
Cantoria, 39120
Study site
Castellon, 12004
Study site
Madrid, 28006
Study site
Madrid, 28035
Study site
Madrid, 28040
Study site
Madrid, 28046
Study site
Valencia, 46010
Germany6 sites
Study site
Berlin, 12157
Study site
Frankfurt am Main, 60528
Study site
Halle, 06112
Study site
Kremmen OT Somerfeld, 16766
Study site
Markgröningen, 71706
Study site
Schwandorf in Bayern, 92421
Poland6 sites
Study site
Bialystok, 15-276
Study site
Katowice, 40-635
Study site
Krakow, 31-826
Study site
Lublin, 20-718
Study site
Lublin, 20-951
Study site
Warsaw, 00-909
Serbia5 sites
Study site
Belgrade, 11000
Study site
Kragujevac, 34000
Study site
Niš, 18000
Study site
Novi Sad, 21000
Study site
Subotica, 24000
Sweden5 sites
Study site
Falköping, 52185
Study site
Gothenburg, 41685
Study site
Kalmar, 39185
Study site
Motala, 59185
Study site
Stockholm, 11883
Czechia4 sites
Study site
Brno, 66250
Study site
Kladno, 27259
Study site
Prague, 18000
Study site
Třebíč, 67401
Denmark4 sites
Study site
Copenhagen, 2300
Study site
Herlev, 2730
Study site
Hørsholm, 2970
Study site
Silkeborg, 8600
Austria3 sites
Study site
Innsbruck, 6020
Study site
Vienna, 1090
Study site
Vienna, 1130
Bosnia and Herzegovina3 sites
Study site
Foca, 73300
Study site
Sarajevo, 71000
Study site
Tuzla, 75000
Latvia3 sites
Study site
Riga, LV 1004
Study site
Riga, LV 1005
Study site
Valmiera, 4201
Norway3 sites
Study site
Elverum, 2409
Study site
Trondheim, 7006
Study site
Tynset, 2500
Slovakia2 sites
Study site
Banska Bysterica, 974 01
Study site
Ružomberok, 034 26
About this study
Official title: Direct Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement.---A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Enoxaparin
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.
- Conditions
- Thromboembolism
- Being tested
- YM150
- Keywords
- Hip replacement, Arthroplasty, Prevention, Thromboembolism, Treatment outcomes, Arthroplasty, replacement, hip
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM150Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of total venous thromboembolism (VTE) during hospitalization phase
Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major
Secondary outcomes (7)
Proximal or distal deep vein thrombosis (DVT) during hospitalization phase
Symptomatic VTE
Rate of total VTE
Death due to any cause during treatment
Incidence of the bleeding types:
Major or clinically relevant non-major bleeding, Major bleeding,
Clinically relevant non-major bleeding, Minor bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Enrolment
- 1,141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Responsible party
- Sponsor
- Investigators
- Astellas Pharma Europe B.V., Medical Clinical Development, Principal investigator, Department of Orthopedics, Surgical Sciences, Gothenburg University Sahlgrenska/ÖSTRA University Hospital, Goteborg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353678
- Sponsor's protocol ID
- 150-CL-008
- Status last verified
- Mar 2013
- First submitted
- 18 Jul 2006
- Last updated
- 21 Mar 2013
- Results posted
- No
Publications
Eriksson BI, Turpie AG, Lassen MR, Prins MH, Agnelli G, Kalebo P, Wetherill G, Wilpshaar JW, Meems L; ONYX-2 STUDY GROUP. Prevention of venous thromboembolism with an oral factor Xa inhibitor, YM150, after total hip arthroplasty. A dose finding study (ONYX-2). J Thromb Haemost. 2010 Apr;8(4):714-21. doi: 10.1111/j.1538-7836.2010.03748.x. Epub 2010 Jan 17.
PubMed 20088935
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement.---A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Enoxaparin
- ClinicalTrials.gov ID
- NCT00353678
- Acronym / sponsor ID
- 150-CL-008
- Conditions
- Thromboembolism
- Keywords
- Hip replacement, Arthroplasty, Prevention, Thromboembolism, Treatment outcomes, Arthroplasty, replacement, hip
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,141 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Study start
- Jun 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 19 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.
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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 hip replacement
- Age 18 years or over
- Written informed consent obtained
Key exclusion criteria (4 listed)
- Documented history or considered at increased risk of venous thromboembolism
- Subjects considered at increased risk of bleeding
- Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment
- Concomitant use of anticoagulants/ antiplatelet agents
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 |
|---|---|---|
| YM150 | Drug | – |
Primary outcome
Rate of total venous thromboembolism (VTE) during hospitalization phase
Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major
7 secondary outcomes
Proximal or distal deep vein thrombosis (DVT) during hospitalization phase
Symptomatic VTE
Rate of total VTE
Death due to any cause during treatment
Incidence of the bleeding types:
Major or clinically relevant non-major bleeding, Major bleeding,
Clinically relevant non-major bleeding, Minor 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 21 Mar 2013.
- Background: PubMed 20088935Eriksson BI, Turpie AG, Lassen MR, Prins MH, Agnelli G, Kalebo P, Wetherill G, Wilpshaar JW, Meems L; ONYX-2 STUDY GROUP. Prevention of venous thromboembolism with an oral factor Xa inhibitor, YM150, after total hip arthroplasty. A dose finding study (ONYX-2). J Thromb Haemost. 2010 Apr;8(4):714-21. doi: 10.1111/j.1538-7836.2010.03748.x. Epub 2010 Jan 17.
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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.
Astellas Pharma Europe B.V., Medical Clinical Development principal investigator
Department of Orthopedics, Surgical Sciences, Gothenburg University Sahlgrenska/ÖSTRA University Hospital, Goteborg, Sweden
79 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM150 in people with Thromboembolism, run by Astellas Pharma Inc at 79 sites in 17 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 4 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 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in Russia, Italy, Spain, Germany, Poland and 12 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?
Rate of total venous thromboembolism (VTE) during hospitalization phase. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00353678, which also lists 1 linked publication.
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 21 Mar 2013.