A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery (ONYX-3)

October 5, 2015 updated by: Astellas Pharma Europe B.V.

A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 Bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1992

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Kogarah, Australia, 2217
    • Victoria
      • Box Hill, Victoria, Australia, 3128
      • Ringwood East, Victoria, Australia, 3135
      • Windsor, Victoria, Australia, 3181
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • Austria
      • Graz, Austria, 8036
      • Innsbruck, Austria, A-6020
      • Linz, Austria, 4010
      • Vienna, Austria, 1090
      • Vienna, Austria, 1130
  • Bosnia and Herzegovina
      • Foca, Bosnia and Herzegovina, 73300
  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Porto Alegre, Rio Grande do Sul, Brazil, 30130-100
    • So Paulo
      • Sao Paulo, So Paulo, Brazil, 04262-000
  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T4N 6V7
    • Ontario
      • Burlington, Ontario, Canada, L7R 4B7
      • Guelph, Ontario, Canada, N1E 6L9
      • Newmarket, Ontario, Canada, L3Y 2P9
      • Thunder Bay, Ontario, Canada, P7B 6V4
      • Waterloo, Ontario, Canada, N2J 1CA
  • Colombia
      • Barranquilla, Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
    • Santander
      • Floridablanca, Santander, Colombia
  • Czech Republic
      • Brno, Czech Republic, 66250
      • Chomutov, Czech Republic, 43001
      • Havlickuv Brod, Czech Republic, 580 22
      • Jihlava, Czech Republic, 58633
      • Jindrichuv Hradec, Czech Republic, 37738
      • Klatovy, Czech Republic, 33938
      • Liberec, Czech Republic, 46001
      • Prague, Czech Republic, 18081
      • Trebic, Czech Republic, 67401
  • Denmark
      • Copenhagen, Denmark, 2400
      • Copenhagen, Denmark, 2300
      • Frederiksberg, Denmark, 2000
      • Herlev, Denmark, 2730
      • Horsholm, Denmark, 2970
      • Silkeborg, Denmark, 8600
  • Estonia
      • Kohtla-Jarve, Estonia, 30322
      • Tallinn, Estonia, 10611
      • Tartu, Estonia, 51014
  • Finland
      • Jyvaskyla, Finland, 40620
      • Oulu, Finland, 90029
  • Germany
      • Mainz, Germany, 55101
      • Marburg, Germany, 35033
  • Hungary
      • Budapest, Hungary, 1113
      • Debrecen, Hungary, 4012
      • Gyor, Hungary, 9023
      • Kecskemet, Hungary, 6000
      • Szeged, Hungary, 6725
      • Szekesfehervar, Hungary, 8000
      • Szekszard, Hungary, 7100
      • Szolnok, Hungary, 5000
  • India
    • Andhra Pradesh
      • Hyderabaad, Andhra Pradesh, India, 500034
      • Secunderabad, Andhra Pradesh, India, 500003
    • Andhra Prasdesh
      • Secunderabad, Andhra Prasdesh, India, 500003
    • Gujarat
      • Baroda, Gujarat, India, 390007
    • Haryana
      • Gurgaon, Haryana, India, 122001
    • Jharkhand
      • Jamshedpur, Jharkhand, India, 831004
    • Karnataka
      • Bangalore, Karnataka, India, 560054
      • Kormangala, Karnataka, India, 5600034
      • Mangalore, Karnataka, India, 575001
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, 462010
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
  • Israel
      • Afula, Israel, 18101
      • Haifa, Israel, 31096
      • Kfar Saba, Israel, 44281
      • Petach Tikva, Israel, 49100
      • Rehovot, Israel, 76100
  • Italy
      • Bologna, Italy, 40136
      • Milano, Italy, 20132
  • Latvia
      • Daugavpils, Latvia, LV4317
      • Liepaja, Latvia, LV 3400
      • Riga, Latvia, LV1004
      • Riga, Latvia, LV 1005
      • Valmiera, Latvia, LV4201
  • Lithuania
      • Kaunas, Lithuania, LT-44320
      • Klaipeda, Lithuania, 92288
      • Vilnius, Lithuania, 04130
  • Norway
      • Gjovik, Norway, 2819
      • Kongsvinger, Norway, 2226
      • Lillehammer, Norway, 2629
      • Tonsberg, Norway, 3116
      • Tynset, Norway, 2500
  • Poland
      • Glogow Malopolski, Poland, 36-060
      • Konskie, Poland, 26-200
      • Krakow, Poland, 31-913
      • Lodz, Poland, 93-513
      • Lodz, Poland, 91-002
      • Lublin, Poland, 20-718
      • Opole, Poland, 45-372
      • Otwock, Poland, 05-400
      • Poznan, Poland, 61-485
      • Warszawa, Poland, 00-909
      • Warszawa, Poland, 02-005
  • Puerto Rico
      • Curitiba, Puerto Rico, 80060-900
  • Romania
      • Bucharest, Romania, 021659
      • Bucharest, Romania, 042122
      • Bucharest, Romania, 021382
      • Cluj, Romania, 0400132
      • Craiova, Romania, 20116
      • Iasi, Romania, 0700483
    • Timis
      • Timisoara, Timis, Romania, 300736
  • Russian Federation
      • Kazan, Russian Federation, 420012
      • Moscow, Russian Federation, 119049
      • Nizhny Novgorod, Russian Federation, 603155
      • Novosibirsk, Russian Federation, 630091
      • Omsk, Russian Federation, 644043
      • Samara, Russian Federation, 443095
      • St. Petersburg, Russian Federation, 194354
      • St. Petersburg, Russian Federation, 194291
      • Yaroslavl, Russian Federation, 150003
  • Slovakia
      • Banska Bysterica, Slovakia, 975 01
      • Kosice Saca, Slovakia, 04015
      • Presov, Slovakia, 08181
  • South Africa
      • Benoni, South Africa, 1501
      • Bryanston, South Africa, 2021
      • Port Elizabeth, South Africa, 6014
      • Pretoria, South Africa, 0001
      • Pretoria, South Africa, 0083
    • Cape Town
      • Worcester, Cape Town, South Africa, 6850
  • Spain
      • Barcelona, Spain, 08036
      • Castello, Spain, 12004
      • Madrid, Spain, 28006
      • Palma Mallorca, Spain, 07014
  • Sweden
      • Kalmar, Sweden, 391 85
      • Molndal, Sweden, 41685
      • Motala, Sweden, 591 85
      • Stockholm, Sweden, 182 88
      • Varberg, Sweden, 43281
  • Ukraine
      • Cherkassy, Ukraine, 18009
      • Ivano-Frankovsk, Ukraine, 76008
      • Lviv, Ukraine, 79495
      • Sevastopol, Ukraine, 99018
  • United Kingdom
      • London, United Kingdom, SE5 9RS
      • Northampton, United Kingdom, NN1 5 BD
    • Surrey
      • Epsom, Surrey, United Kingdom, KT18 7EG
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
      • Phoenix, Arizona, United States, 85023
      • Tuscon, Arizona, United States, 85712
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Long Beach, California, United States, 90806
      • Torrance, California, United States, 90507
    • Colorado
      • Aurora, Colorado, United States, 80015
    • Florida
      • DeLand, Florida, United States, 32720
      • Pinellas Park, Florida, United States, 33781
      • Sarasota, Florida, United States, 34239
      • Tamarac, Florida, United States, 33321
    • Idaho
      • Meridian, Idaho, United States, 83642
    • Kentucky
      • Lexington, Kentucky, United States, 40509
    • Maryland
      • Baltimore, Maryland, United States, 21215
    • South Carolina
      • Charleston, South Carolina, United States, 29414
    • Texas
      • Austin, Texas, United States, 78745
      • Dallas, Texas, United States, 75231
      • Houston, Texas, United States, 77024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is scheduled for elective hip replacement surgery

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. YM150, Dose X, twice daily
Drug: YM150
oral
Experimental: 2, YM150, Dose X, once daily
Drug: YM150
oral
Experimental: 3. YM150, Dose Y, twice daily
Drug: YM150
oral
Experimental: 4. YM150, Dose Y, once daily
Drug: YM150
oral
Active Comparator: 5. Enoxaparin
Drug: enoxaparin
SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic Venous Thromboembolisms and death from all causes
Time Frame: 12 days
12 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of all Venous Thromboembolic events
Time Frame: Until day 12, during the treatment period, follow-up period and entire study period
Until day 12, during the treatment period, follow-up period and entire study period
Incidence of Bleeding events
Time Frame: During the treatment period, follow-up period and entire study period
During the treatment period, follow-up period and entire study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

April 30, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (Estimate)

May 15, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150-CL-040
  • 2008-004416-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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