A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery (ONYX-3)
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00902928
First received: April 30, 2009
Last updated: August 2, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thromboembolism Arthroplasty, Replacement, Hip |
Drug: YM150 Drug: enoxaparin |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Incidence of symptomatic Venous Thromboembolisms and death from all causes [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of all Venous Thromboembolic events [ Time Frame: Until day 12, during the treatment period, follow-up period and entire study period ] [ Designated as safety issue: No ]
- Incidence of Bleeding events [ Time Frame: During the treatment period, follow-up period and entire study period ] [ Designated as safety issue: Yes ]
| Enrollment: | 1992 |
| Study Start Date: | April 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902928
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Hide Study LocationsLocations
| United States, Arizona | |
| Phoenix, Arizona, United States, 85050 | |
| Phoenix, Arizona, United States, 85023 | |
| Tuscon, Arizona, United States, 85712 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Long Beach, California, United States, 90806 | |
| Torrance, California, United States, 90507 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80015 | |
| United States, Florida | |
| DeLand, Florida, United States, 32720 | |
| Pinellas Park, Florida, United States, 33781 | |
| Sarasota, Florida, United States, 34239 | |
| Tamarac, Florida, United States, 33321 | |
| United States, Idaho | |
| Meridian, Idaho, United States, 83642 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40509 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21215 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29414 | |
| United States, Texas | |
| Austin, Texas, United States, 78745 | |
| Dallas, Texas, United States, 75231 | |
| Houston, Texas, United States, 77024 | |
| Australia, Victoria | |
| Box Hill, Victoria, Australia, 3128 | |
| Ringwood East, Victoria, Australia, 3135 | |
| Windsor, Victoria, Australia, 3181 | |
| Australia, Western Australia | |
| Perth, Western Australia, Australia, 6000 | |
| Australia | |
| Kogarah, Australia, 2217 | |
| 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 | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90610-000 | |
| Porto Alegre, Rio Grande do Sul, Brazil, 30130-100 | |
| Sao Paulo, So Paulo, Brazil, 04262-000 | |
| Canada, Alberta | |
| Red Deer, Alberta, Canada, T4N 6V7 | |
| Canada, 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 | |
| Medellin, Antioquia, Colombia | |
| Bogota, Cundinamarca, Colombia | |
| Floridablanca, Santander, Colombia | |
| Barranquilla, 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, 2300 | |
| Copenhagen, Denmark, 2400 | |
| 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 | |
| Hyderabaad, Andhra Pradesh, India, 500034 | |
| Secunderabad, Andhra Pradesh, India, 500003 | |
| Secunderabad, Andhra Prasdesh, India, 500003 | |
| Baroda, Gujarat, India, 390007 | |
| Gurgaon, Haryana, India, 122001 | |
| Jamshedpur, Jharkhand, India, 831004 | |
| Bangalore, Karnataka, India, 560054 | |
| Kormangala, Karnataka, India, 5600034 | |
| Mangalore, Karnataka, India, 575001 | |
| Bhopal, Madhya Pradesh, India, 462010 | |
| 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, LV 1005 | |
| Riga, Latvia, LV1004 | |
| 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, 91-002 | |
| Lodz, Poland, 93-513 | |
| 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 | |
| Timisoara, Timis, Romania, 300736 | |
| Bucharest, Romania, 021659 | |
| Bucharest, Romania, 021382 | |
| Bucharest, Romania, 042122 | |
| Cluj, Romania, 0400132 | |
| Craiova, Romania, 20116 | |
| Iasi, Romania, 0700483 | |
| 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 | |
| Worcester, Cape Town, South Africa, 6850 | |
| Benoni, South Africa, 1501 | |
| Bryanston, South Africa, 2021 | |
| Port Elizabeth, South Africa, 6014 | |
| Pretoria, South Africa, 0083 | |
| Pretoria, South Africa, 0001 | |
| 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 | |
| Epsom, Surrey, United Kingdom, KT18 7EG | |
| London, United Kingdom, SE5 9RS | |
| Northampton, United Kingdom, NN1 5 BD | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Chair: | Use Central Contact | Astellas Pharma Europe BV |
More Information
No publications provided
| Responsible Party: | Disclosure Office Europe, Astellas Pharma Europe BV |
| ClinicalTrials.gov Identifier: | NCT00902928 History of Changes |
| Other Study ID Numbers: | 150-CL-040, 2008-004416-13 |
| Study First Received: | April 30, 2009 |
| Last Updated: | August 2, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Agency for Health and Food Safety Brazil: National Health Surveillance Agency Canada: Health Canada China: Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Croatia: Ministry of Health and Social Care Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy India: Drugs Controller General of India Israel: Ministry of Health Italy: Ethics Committee Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Norway: Norwegian Medicines Agency Peru: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control Slovenia: Agency for Medicinal Products - Ministry of Health South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Bosnia and Herzegovina: Republic of Srpska Drug Agency |
Keywords provided by Astellas Pharma Inc:
|
Elective hip replacement surgery Factor Xa Venous Thromboembolism Thrombosis |
Anticoagulants Prevention YM150 |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Enoxaparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013