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

NCT00902928 | Completed Phase 2 DMC

• 2 other identifiers: 150-CL-0402008-004416-13
• Study Type: interventional
• Target: 1,992
• Locations: 26 countries
• Sites: 148

Brief 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.

Conditions

Venous Thromboembolism; Arthroplasty, Replacement, Hip

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of symptomatic Venous Thromboembolisms and death from all causes

  12 days

Secondary Outcomes (2)

• Incidence of all Venous Thromboembolic events

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

• Incidence of Bleeding events

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

Study Arms (5)

1. YM150, Dose X, twice daily

EXPERIMENTAL

Drug: YM150

2, YM150, Dose X, once daily

EXPERIMENTAL

Drug: YM150

3. YM150, Dose Y, twice daily

EXPERIMENTAL

Drug: YM150

4. YM150, Dose Y, once daily

EXPERIMENTAL

Drug: YM150

5. Enoxaparin

ACTIVE COMPARATOR

Drug: enoxaparin

Interventions

YM150 DRUG

oral

1. YM150, Dose X, twice daily; 2, YM150, Dose X, once daily; 3. YM150, Dose Y, twice daily; 4. YM150, Dose Y, once daily

enoxaparin DRUG

SC injection

5. Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is scheduled for elective hip replacement surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (156)

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Phoenix, Arizona, 85023, United States

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Phoenix, Arizona, 85050, United States

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Tuscon, Arizona, 85712, United States

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Little Rock, Arkansas, 72205, United States

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Long Beach, California, 90806, United States

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Torrance, California, 90507, United States

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Aurora, Colorado, 80015, United States

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DeLand, Florida, 32720, United States

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Pinellas Park, Florida, 33781, United States

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Sarasota, Florida, 34239, United States

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Tamarac, Florida, 33321, United States

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Meridian, Idaho, 83642, United States

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Lexington, Kentucky, 40509, United States

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Baltimore, Maryland, 21215, United States

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Charleston, South Carolina, 29414, United States

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Austin, Texas, 78745, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77024, United States

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Box Hill, Victoria, 3128, Australia

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Ringwood East, Victoria, 3135, Australia

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Windsor, Victoria, 3181, Australia

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Perth, Western Australia, 6000, Australia

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Kogarah, 2217, Australia

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Graz, 8036, Austria

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Innsbruck, A-6020, Austria

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Linz, 4010, Austria

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Vienna, 1090, Austria

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Vienna, 1130, Austria

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Foča, 73300, Bosnia and Herzegovina

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Curitiba, Puerto Rico, 80060-900, Brazil

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Porto Alegre, Rio Grande do Sul, 30130-100, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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São Paulo, So Paulo, 04262-000, Brazil

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Red Deer, Alberta, T4N 6V7, Canada

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Burlington, Ontario, L7R 4B7, Canada

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Guelph, Ontario, N1E 6L9, Canada

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Newmarket, Ontario, L3Y 2P9, Canada

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Thunder Bay, Ontario, P7B 6V4, Canada

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Waterloo, Ontario, N2J 1CA, Canada

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Medellín, Antioquia, Colombia

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Bogota, Cundinamarca, Colombia

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Floridablanca, Santander Department, Colombia

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Barranquilla, Colombia

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Brno, 66250, Czechia

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Chomutov, 43001, Czechia

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Havlíčkův Brod, 580 22, Czechia

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Jihlava, 58633, Czechia

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Jindřichův Hradec, 37738, Czechia

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Klatovy, 33938, Czechia

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Liberec, 46001, Czechia

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Prague, 18081, Czechia

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Třebíč, 67401, Czechia

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Copenhagen, 2300, Denmark

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Copenhagen, 2400, Denmark

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Frederiksberg, 2000, Denmark

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Herlev, 2730, Denmark

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Hørsholm, 2970, Denmark

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Silkeborg, 8600, Denmark

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Kohtla-Järve, 30322, Estonia

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Tallinn, 10611, Estonia

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Tartu, 51014, Estonia

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Jyväskylä, 40620, Finland

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Oulu, 90029, Finland

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Mainz, 55101, Germany

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Marburg, 35033, Germany

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Budapest, 1113, Hungary

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Debrecen, 4012, Hungary

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Győr, 9023, Hungary

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Kecskemét, 6000, Hungary

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Szeged, 6725, Hungary

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Szekszárd, 7100, Hungary

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Székesfehérvár, 8000, Hungary

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Szolnok, 5000, Hungary

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Hyderabaad, Andhra Pradesh, 500034, India

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Secunderabad, Andhra Pradesh, 500003, India

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Secunderabad, Andhra Prasdesh, 500003, India

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Vadodara, Gujarat, 390007, India

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Gurgaon, Haryana, 122001, India

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Jamshedpur, Jharkhand, 831004, India

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Bangalore, Karnataka, 560054, India

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Kormangala, Karnataka, 5600034, India

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Mangalore, Karnataka, 575001, India

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Bhopal, Madhya Pradesh, 462010, India

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Jaipur, Rajasthan, 302004, India

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Afula, 18101, Israel

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Haifa, 31096, Israel

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Kfar Saba, 44281, Israel

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Petah Tikva, 49100, Israel

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Rehovot, 76100, Israel

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Bologna, 40136, Italy

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Milan, 20132, Italy

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Daugavpils, LV4317, Latvia

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Liepāja, LV 3400, Latvia

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Riga, LV 1005, Latvia

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Riga, LV1004, Latvia

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Valmiera, LV4201, Latvia

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Kaunas, LT-44320, Lithuania

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Klaipėda, 92288, Lithuania

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Vilnius, 04130, Lithuania

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Gjøvik, 2819, Norway

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Kongsvinger, 2226, Norway

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Lillehammer, 2629, Norway

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Tynset, 2500, Norway

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Tønsberg, 3116, Norway

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Gmina Końskie, 26-200, Poland

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Głogów Małopolski, 36-060, Poland

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Krakow, 31-913, Poland

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Lodz, 91-002, Poland

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Lodz, 93-513, Poland

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Lublin, 20-718, Poland

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Opole, 45-372, Poland

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Otwock, 05-400, Poland

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Poznan, 61-485, Poland

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Warsaw, 00-909, Poland

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Warsaw, 02-005, Poland

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Timișoara, Timiș County, 300736, Romania

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Bucharest, 021382, Romania

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Bucharest, 021659, Romania

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Bucharest, 042122, Romania

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Cluj-Napoca, 0400132, Romania

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Craiova, 20116, Romania

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Iași, 0700483, Romania

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Kazan', 420012, Russia

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Moscow, 119049, Russia

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Nizhny Novgorod, 603155, Russia

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Novosibirsk, 630091, Russia

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Omsk, 644043, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 194354, Russia

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Samara, 443095, Russia

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Yaroslavl, 150003, Russia

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Banska Bysterica, 975 01, Slovakia

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Kosice Saca, 04015, Slovakia

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Prešov, 08181, Slovakia

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Worcester, Cape Town, 6850, South Africa

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Benoni, 1501, South Africa

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Bryanston, 2021, South Africa

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Port Elizabeth, 6014, South Africa

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Pretoria, 0001, South Africa

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Pretoria, 0083, South Africa

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Barcelona, 08036, Spain

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Castelló, 12004, Spain

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Madrid, 28006, Spain

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Palma Mallorca, 07014, Spain

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Kalmar, 391 85, Sweden

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Motala, 591 85, Sweden

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Mölndal, 41685, Sweden

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Stockholm, 182 88, Sweden

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Varberg, 43281, Sweden

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Cherkassy, 18009, Ukraine

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Ivano-Frankivsk, 76008, Ukraine

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Lviv, 79495, Ukraine

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Sevastopol, 99018, Ukraine

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Epsom, Surrey, KT18 7EG, United Kingdom

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London, SE5 9RS, United Kingdom

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Northampton, NN1 5 BD, United Kingdom

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Related Publications (1)

• 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.

  PMID: 24136153 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Use Central Contact

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 15, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

ES (4); AU (5); LI (3); RU (9); SL (3); CO (4); US (18); BO (1); CA (6); GB (3); HU (8); IT (2); LA (5); IL (5); DK (6); IN (11); NO (5); FI (2); PL (11); BR (4); SE (5); UA (4); DE (2); ZA (6); RO (7); CZ (9)