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Venous ThromboembolismPhase 2/3ONYX-3NCT00902928

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

A Phase 2/3 study testing YM150 and enoxaparin in people with Venous Thromboembolism and Arthroplasty, Replacement, Hip, run by Astellas Pharma Europe B.V. at 156 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
YM150 and enoxaparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,992 participants
Where
156 sitesin 28 countries
Study dates
Apr 2009to Aug 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is scheduled for elective hip replacement surgery

Who cannot join

  • 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

Trial locations and contacts

156 sites in 28 countries.

156 sites in 28 countries

United States18 sites

  • Study site

    Aurora, Colorado, 80015

  • Study site

    Austin, Texas, 78745

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Dallas, Texas, 75231

  • Study site

    DeLand, Florida, 32720

  • Study site

    Houston, Texas, 77024

  • Study site

    Lexington, Kentucky, 40509

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Long Beach, California, 90806

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Phoenix, Arizona, 85023

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Tamarac, Florida, 33321

  • Study site

    Torrance, California, 90507

  • Study site

    Tuscon, Arizona, 85712

Other trials in United States

India11 sites

  • Study site

    Bangalore, Karnataka, 560054

  • Study site

    Bhopal, Madhya Pradesh, 462010

  • Study site

    Gurgaon, Haryana, 122001

  • Study site

    Hyderabaad, Andhra Pradesh, 500034

  • Study site

    Jaipur, Rajasthan, 302004

  • Study site

    Jamshedpur, Jharkhand, 831004

  • Study site

    Kormangala, Karnataka, 5600034

  • Study site

    Mangalore, Karnataka, 575001

  • Study site

    Secunderabad, Andhra Pradesh, 500003

  • Study site

    Secunderabad, Andhra Prasdesh, 500003

  • Study site

    Vadodara, Gujarat, 390007

Other trials in India

Poland11 sites

  • Study site

    Głogów Małopolski, 36-060

  • Study site

    Gmina Końskie, 26-200

  • Study site

    Krakow, 31-913

  • Study site

    Lodz, 91-002

  • Study site

    Lodz, 93-513

  • Study site

    Lublin, 20-718

  • Study site

    Opole, 45-372

  • Study site

    Otwock, 05-400

  • Study site

    Poznan, 61-485

  • Study site

    Warsaw, 00-909

  • Study site

    Warsaw, 02-005

Other trials in Poland

Czechia9 sites

  • Study site

    Brno, 66250

  • Study site

    Chomutov, 43001

  • Study site

    Havlíčkův Brod, 580 22

  • Study site

    Jihlava, 58633

  • Study site

    Jindřichův Hradec, 37738

  • Study site

    Klatovy, 33938

  • Study site

    Liberec, 46001

  • Study site

    Prague, 18081

  • Study site

    Třebíč, 67401

Other trials in Czechia

Russia9 sites

  • Study site

    Kazan', 420012

  • Study site

    Moscow, 119049

  • Study site

    Nizhny Novgorod, 603155

  • Study site

    Novosibirsk, 630091

  • Study site

    Omsk, 644043

  • Study site

    Saint Petersburg, 194291

  • Study site

    Saint Petersburg, 194354

  • Study site

    Samara, 443095

  • Study site

    Yaroslavl, 150003

Other trials in Russia

Hungary8 sites

  • Study site

    Budapest, 1113

  • Study site

    Debrecen, 4012

  • Study site

    Győr, 9023

  • Study site

    Kecskemét, 6000

  • Study site

    Szeged, 6725

  • Study site

    Székesfehérvár, 8000

  • Study site

    Szekszárd, 7100

  • Study site

    Szolnok, 5000

Other trials in Hungary

Romania7 sites

  • Study site

    Bucharest, 021382

  • Study site

    Bucharest, 021659

  • Study site

    Bucharest, 042122

  • Study site

    Cluj-Napoca, 0400132

  • Study site

    Craiova, 20116

  • Study site

    Iași, 0700483

  • Study site

    Timișoara, Timiș County, 300736

Other trials in Romania

Canada6 sites

  • Study site

    Burlington, Ontario, L7R 4B7

  • Study site

    Guelph, Ontario, N1E 6L9

  • Study site

    Newmarket, Ontario, L3Y 2P9

  • Study site

    Red Deer, Alberta, T4N 6V7

  • Study site

    Thunder Bay, Ontario, P7B 6V4

  • Study site

    Waterloo, Ontario, N2J 1CA

Other trials in Canada

Denmark6 sites

  • Study site

    Copenhagen, 2300

  • Study site

    Copenhagen, 2400

  • Study site

    Frederiksberg, 2000

  • Study site

    Herlev, 2730

  • Study site

    Hørsholm, 2970

  • Study site

    Silkeborg, 8600

Other trials in Denmark

South Africa6 sites

  • Study site

    Benoni, 1501

  • Study site

    Bryanston, 2021

  • Study site

    Port Elizabeth, 6014

  • Study site

    Pretoria, 0001

  • Study site

    Pretoria, 0083

  • Study site

    Worcester, Cape Town, 6850

Other trials in South Africa

Australia5 sites

  • Study site

    Box Hill, Victoria, 3128

  • Study site

    Kogarah, 2217

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Ringwood East, Victoria, 3135

  • Study site

    Windsor, Victoria, 3181

Other trials in Australia

Austria5 sites

  • Study site

    Graz, 8036

  • Study site

    Innsbruck, A-6020

  • Study site

    Linz, 4010

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1130

Other trials in Austria

Israel5 sites

  • Study site

    Afula, 18101

  • Study site

    Haifa, 31096

  • Study site

    Kfar Saba, 44281

  • Study site

    Petah Tikva, 49100

  • Study site

    Rehovot, 76100

Other trials in Israel

Latvia5 sites

  • Study site

    Daugavpils, LV4317

  • Study site

    Liepāja, LV 3400

  • Study site

    Riga, LV 1005

  • Study site

    Riga, LV1004

  • Study site

    Valmiera, LV4201

Other trials in Latvia

Norway5 sites

  • Study site

    Gjøvik, 2819

  • Study site

    Kongsvinger, 2226

  • Study site

    Lillehammer, 2629

  • Study site

    Tønsberg, 3116

  • Study site

    Tynset, 2500

Other trials in Norway

Sweden5 sites

  • Study site

    Kalmar, 391 85

  • Study site

    Mölndal, 41685

  • Study site

    Motala, 591 85

  • Study site

    Stockholm, 182 88

  • Study site

    Varberg, 43281

Other trials in Sweden

Brazil4 sites

  • Study site

    Curitiba, Puerto Rico, 80060-900

  • Study site

    Porto Alegre, Rio Grande do Sul, 30130-100

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    São Paulo, So Paulo, 04262-000

Other trials in Brazil

Colombia4 sites

  • Study site

    Barranquilla

  • Study site

    Bogota, Cundinamarca

  • Study site

    Floridablanca, Santander Department

  • Study site

    Medellín, Antioquia

Other trials in Colombia

Spain4 sites

  • Study site

    Barcelona, 08036

  • Study site

    Castelló, 12004

  • Study site

    Madrid, 28006

  • Study site

    Palma Mallorca, 07014

Other trials in Spain

Ukraine4 sites

  • Study site

    Cherkassy, 18009

  • Study site

    Ivano-Frankivsk, 76008

  • Study site

    Lviv, 79495

  • Study site

    Sevastopol, 99018

Other trials in Ukraine

Estonia3 sites

  • Study site

    Kohtla-Järve, 30322

  • Study site

    Tallinn, 10611

  • Study site

    Tartu, 51014

Other trials in Estonia

Lithuania3 sites

  • Study site

    Kaunas, LT-44320

  • Study site

    Klaipėda, 92288

  • Study site

    Vilnius, 04130

Other trials in Lithuania

Slovakia3 sites

  • Study site

    Banska Bysterica, 975 01

  • Study site

    Kosice Saca, 04015

  • Study site

    Prešov, 08181

Other trials in Slovakia

United Kingdom3 sites

  • Study site

    Epsom, Surrey, KT18 7EG

  • Study site

    London, SE5 9RS

  • Study site

    Northampton, NN1 5 BD

Other trials in United Kingdom

Finland2 sites

  • Study site

    Jyväskylä, 40620

  • Study site

    Oulu, 90029

Other trials in Finland

Germany2 sites

  • Study site

    Mainz, 55101

  • Study site

    Marburg, 35033

Other trials in Germany

Italy2 sites

  • Study site

    Bologna, 40136

  • Study site

    Milan, 20132

Other trials in Italy

Bosnia and Herzegovina1 site

  • Study site

    Foca, 73300

Other trials in Bosnia and Herzegovina

About this study

Official title: 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.

Being tested
YM150, enoxaparin
Keywords
Elective hip replacement surgery, Factor Xa, Venous Thromboembolism, Thrombosis, Anticoagulants, Prevention, YM150
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.

Study groups in NCT00902928
Study groupRoleWhat they receive
1. YM150, Dose X, twice dailyExperimentalNot described
Receives: Drug: YM150
2, YM150, Dose X, once dailyExperimentalNot described
Receives: Drug: YM150
3. YM150, Dose Y, twice dailyExperimentalNot described
Receives: Drug: YM150
4. YM150, Dose Y, once dailyExperimentalNot described
Receives: Drug: YM150
5. EnoxaparinActive comparatorNot described
Receives: Drug: enoxaparin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 days

Secondary outcomes (2)

  1. Incidence of all Venous Thromboembolic events

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

  2. Incidence of Bleeding events

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJun 2010
  4. Study completionAug 2010

Resources

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
1,992 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00902928
Sponsor's protocol ID
150-CL-040
Other IDs
2008-004416-13, 2008
Acronym
ONYX-3
Status last verified
Oct 2015
First submitted
30 Apr 2009
Last updated
27 Oct 2015
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing YM150 and enoxaparin in people with Venous Thromboembolism and Arthroplasty, Replacement, Hip, run by Astellas Pharma Europe B.V. at 156 sites in 28 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 1 inclusion and 3 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 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, India, Poland, Czechia, Russia and 23 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 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?

Incidence of symptomatic Venous Thromboembolisms and death from all causes (time frame: 12 days). 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 NCT00902928, 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 27 Oct 2015.

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