Clinical trial NCT00902928: A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Venous Thromboembolism
Arthroplasty, Replacement, Hip
Keywords: Elective hip replacement surgery
Factor Xa
Venous Thromboembolism
Thrombosis
Anticoagulants
Prevention
YM150
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 1992
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Incidence of symptomatic Venous Thromboembolisms and death from all causes
timeFrame: 12 days
Secondary outcomes:
measure: Incidence of all Venous Thromboembolic events
timeFrame: Until day 12, during the treatment period, follow-up period and entire study period
measure: Incidence of Bleeding events
timeFrame: During the treatment period, follow-up period and entire study period
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tuscon
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Long Beach
country: United States
state: California
city: Torrance
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: DeLand
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Meridian
country: United States
state: Idaho
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Charleston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Box Hill
country: Australia
state: Victoria
city: Ringwood East
country: Australia
state: Victoria
city: Windsor
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Kogarah
country: Australia
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Vienna
country: Austria
city: Vienna
country: Austria
city: Foca
country: Bosnia and Herzegovina
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Sao Paulo
country: Brazil
state: So Paulo
city: Red Deer
country: Canada
state: Alberta
city: Burlington
country: Canada
state: Ontario
city: Guelph
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Medellin
country: Colombia
state: Antioquia
city: Bogota
country: Colombia
state: Cundinamarca
city: Floridablanca
country: Colombia
state: Santander
city: Barranquilla
country: Colombia
city: Brno
country: Czech Republic
city: Chomutov
country: Czech Republic
city: Havlickuv Brod
country: Czech Republic
city: Jihlava
country: Czech Republic
city: Jindrichuv Hradec
country: Czech Republic
city: Klatovy
country: Czech Republic
city: Liberec
country: Czech Republic
city: Prague
country: Czech Republic
city: Trebic
country: Czech Republic
city: Copenhagen
country: Denmark
city: Copenhagen
country: Denmark
city: Frederiksberg
country: Denmark
city: Herlev
country: Denmark
city: Horsholm
country: Denmark
city: Silkeborg
country: Denmark
city: Kohtla-Jarve
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Jyvaskyla
country: Finland
city: Oulu
country: Finland
city: Mainz
country: Germany
city: Marburg
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Kecskemet
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szekszard
country: Hungary
city: Szolnok
country: Hungary
city: Hyderabaad
country: India
state: Andhra Pradesh
city: Secunderabad
country: India
state: Andhra Pradesh
city: Secunderabad
country: India
state: Andhra Prasdesh
city: Baroda
country: India
state: Gujarat
city: Gurgaon
country: India
state: Haryana
city: Jamshedpur
country: India
state: Jharkhand
city: Bangalore
country: India
state: Karnataka
city: Kormangala
country: India
state: Karnataka
city: Mangalore
country: India
state: Karnataka
city: Bhopal
country: India
state: Madhya Pradesh
city: Jaipur
country: India
state: Rajasthan
city: Afula
country: Israel
city: Haifa
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Rehovot
country: Israel
city: Bologna
country: Italy
city: Milano
country: Italy
city: Daugavpils
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Valmiera
country: Latvia
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Gjovik
country: Norway
city: Kongsvinger
country: Norway
city: Lillehammer
country: Norway
city: Tonsberg
country: Norway
city: Tynset
country: Norway
city: Glogow Malopolski
country: Poland
city: Konskie
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Opole
country: Poland
city: Otwock
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Curitiba
country: Puerto Rico
city: Timisoara
country: Romania
state: Timis
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Samara
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Banska Bysterica
country: Slovakia
city: Kosice Saca
country: Slovakia
city: Presov
country: Slovakia
city: Worcester
country: South Africa
state: Cape Town
city: Benoni
country: South Africa
city: Bryanston
country: South Africa
city: Port Elizabeth
country: South Africa
city: Pretoria
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: Castello
country: Spain
city: Madrid
country: Spain
city: Palma Mallorca
country: Spain
city: Kalmar
country: Sweden
city: Molndal
country: Sweden
city: Motala
country: Sweden
city: Stockholm
country: Sweden
city: Varberg
country: Sweden
city: Cherkassy
country: Ukraine
city: Ivano-Frankovsk
country: Ukraine
city: Lviv
country: Ukraine
city: Sevastopol
country: Ukraine
city: Epsom
country: United Kingdom
state: Surrey
city: London
country: United Kingdom
city: Northampton
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: 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.