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CompletedNCT00902928ONYX-3Updated Oct 27, 2015

A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery

A Phase 2/3 interventional study of YM150 and enoxaparin in Venous Thromboembolism and Arthroplasty, Replacement, Hip, sponsored by Astellas Pharma Europe B.V.. Completed at 156 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-27.

Sponsored by Astellas Pharma Europe B.V. (part of Astellas Pharma Inc) · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
1,992
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.

02

Conditions studied

  • Venous Thromboembolism
  • Arthroplasty, Replacement, Hip

Keywords

  • Elective hip replacement surgery
  • Factor Xa
  • Venous Thromboembolism
  • Thrombosis
  • Anticoagulants
  • Prevention
  • YM150
03

In context

Venous Thromboembolism

708 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.

This study's enrollment of 1,992 is above the median of 257 across 390 interventional studies indexed under Venous Thromboembolism.

Browse Venous Thromboembolism studies →

Lead sponsor

Astellas Pharma Europe B.V. is the lead sponsor of 94 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is scheduled for elective hip replacement surgery

Exclusion criteria

Exclusion Criteria:

  • Subject has active bleeding or any condition associated with increased risk of bleeding
  • Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study
  • Subject has had an MI or stroke within 3 months before planned hip replacement surgery
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,992 participants (actual)

Study arms

  • Experimental
    1. YM150, Dose X, twice daily

    Drug: YM150

  • Experimental
    2, YM150, Dose X, once daily

    Drug: YM150

  • Experimental
    3. YM150, Dose Y, twice daily

    Drug: YM150

  • Experimental
    4. YM150, Dose Y, once daily

    Drug: YM150

  • Active comparator
    5. Enoxaparin

    Drug: enoxaparin

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of symptomatic Venous Thromboembolisms and death from all causes

    Time frame: 12 days

Secondary outcomes

  1. Incidence of all Venous Thromboembolic events

    Time frame: Until day 12, during the treatment period, follow-up period and entire study period

  2. Incidence of Bleeding events

    Time frame: During the treatment period, follow-up period and entire study period

07

Study locations

156 sites
  • Phoenix, Arizona 85023, United States
  • Phoenix, Arizona 85050, United States
  • Tuscon, Arizona 85712, United States
  • Little Rock, Arkansas 72205, United States
  • Long Beach, California 90806, United States
  • Torrance, California 90507, United States
  • Aurora, Colorado 80015, United States
  • DeLand, Florida 32720, United States
  • Pinellas Park, Florida 33781, United States
  • Sarasota, Florida 34239, United States
  • Tamarac, Florida 33321, United States
  • Meridian, Idaho 83642, United States
  • Lexington, Kentucky 40509, United States
  • Baltimore, Maryland 21215, United States
  • Charleston, South Carolina 29414, United States
  • Austin, Texas 78745, United States
  • Dallas, Texas 75231, United States
  • Houston, Texas 77024, United States
  • Box Hill, Victoria 3128, Australia
  • Ringwood East, Victoria 3135, Australia
  • Windsor, Victoria 3181, Australia
  • Perth, Western Australia 6000, Australia
  • Kogarah, 2217, Australia
  • Graz, 8036, Austria
  • Innsbruck, A-6020, Austria
  • Linz, 4010, Austria
  • Vienna, 1090, Austria
  • Vienna, 1130, Austria
  • Foca, 73300, Bosnia and Herzegovina
  • Curitiba, Puerto Rico 80060-900, Brazil
  • Porto Alegre, Rio Grande do Sul 30130-100, Brazil
  • Porto Alegre, Rio Grande do Sul 90610-000, Brazil
  • São Paulo, So Paulo 04262-000, Brazil
  • Red Deer, Alberta T4N 6V7, Canada
  • Burlington, Ontario L7R 4B7, Canada
  • Guelph, Ontario N1E 6L9, Canada
  • Newmarket, Ontario L3Y 2P9, Canada
  • Thunder Bay, Ontario P7B 6V4, Canada
  • Waterloo, Ontario N2J 1CA, Canada
  • Medellín, Antioquia, Colombia
  • Bogota, Cundinamarca, Colombia
  • Floridablanca, Santander Department, Colombia
  • Barranquilla, Colombia
  • Brno, 66250, Czechia
  • Chomutov, 43001, Czechia
  • Havlíčkův Brod, 580 22, Czechia
  • Jihlava, 58633, Czechia
  • Jindřichův Hradec, 37738, Czechia
  • Klatovy, 33938, Czechia
  • Liberec, 46001, Czechia
  • Prague, 18081, Czechia
  • Třebíč, 67401, Czechia
  • Copenhagen, 2300, Denmark
  • Copenhagen, 2400, Denmark
  • Frederiksberg, 2000, Denmark
  • Herlev, 2730, Denmark
  • Hørsholm, 2970, Denmark
  • Silkeborg, 8600, Denmark
  • Kohtla-Järve, 30322, Estonia
  • Tallinn, 10611, Estonia
  • Tartu, 51014, Estonia
  • Jyväskylä, 40620, Finland
  • Oulu, 90029, Finland
  • Mainz, 55101, Germany
  • Marburg, 35033, Germany
  • Budapest, 1113, Hungary
  • Debrecen, 4012, Hungary
  • Győr, 9023, Hungary
  • Kecskemét, 6000, Hungary
  • Szeged, 6725, Hungary
  • Szekszárd, 7100, Hungary
  • Székesfehérvár, 8000, Hungary
  • Szolnok, 5000, Hungary
  • Hyderabaad, Andhra Pradesh 500034, India
  • Secunderabad, Andhra Pradesh 500003, India
  • Secunderabad, Andhra Prasdesh 500003, India
  • Vadodara, Gujarat 390007, India
  • Gurgaon, Haryana 122001, India
  • Jamshedpur, Jharkhand 831004, India
  • Bangalore, Karnataka 560054, India
  • Kormangala, Karnataka 5600034, India
  • Mangalore, Karnataka 575001, India
  • Bhopal, Madhya Pradesh 462010, India
  • Jaipur, Rajasthan 302004, India
  • Afula, 18101, Israel
  • Haifa, 31096, Israel
  • Kfar Saba, 44281, Israel
  • Petah Tikva, 49100, Israel
  • Rehovot, 76100, Israel
  • Bologna, 40136, Italy
  • Milan, 20132, Italy
  • Daugavpils, LV4317, Latvia
  • Liepāja, LV 3400, Latvia
  • Riga, LV 1005, Latvia
  • Riga, LV1004, Latvia
  • Valmiera, LV4201, Latvia
  • Kaunas, LT-44320, Lithuania
  • Klaipėda, 92288, Lithuania
  • Vilnius, 04130, Lithuania
  • Gjøvik, 2819, Norway

Showing the first 100 of 156 sites across 28 countries.

08

References and documents

Publications

  • Eriksson BI, Agnelli G, Gallus AS, Lassen MR, Prins MH, Renfurm RW, Kashiwa M, Turpie AG. Darexaban (YM150) versus enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a randomised phase IIb dose confirmation study (ONYX-3). Thromb Haemost. 2014 Feb;111(2):213-25. doi: 10.1160/TH13-04-0296. Epub 2013 Oct 17. PubMed 24136153 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of Jun 2010 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2009
First posted
May 15, 2009
Start
Apr 2009
Primary completionActual
Jun 2010
CompletionActual
Aug 2010
Results delay requested
Aug 2, 2011
Last update
Oct 27, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00902928
Responsible party
Sponsor
First posted
May 15, 2009
Start date
Apr 2009
Primary completion
Jun 2010
Completion
Aug 2010
Last update
Oct 27, 2015

Study contacts

Use Central Contact
study chair · Astellas Pharma Europe B.V.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Darexaban

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