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

Venous Thromboembolism Clinical Trial

— ONYX-3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902928
• Other study ID #: 150-CL-040
• Secondary ID: 2008-004416-13
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 30, 2009
• Last updated: October 5, 2015
• Start date: April 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Agency for Health and Food SafetyBrazil: National Health Surveillance AgencyCanada: Health CanadaChina: Food and Drug AdministrationColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCroatia: Ministry of Health and Social CareCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIndia: Drugs Controller General of IndiaIsrael: Ministry of HealthItaly: Ethics CommitteeLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencyPeru: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlSlovenia: Agency for Medicinal Products - Ministry of HealthSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUkraine: State Pharmacological Center - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationBosnia and Herzegovina: Republic of Srpska Drug Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1992
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• YM150
oral
• enoxaparin
SC injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Bosnia and Herzegovina,  Brazil,  Canada,  Colombia,  Czech Republic,  Denmark,  Estonia,  Finland,  Germany,  Hungary,  India,  Israel,  Italy,  Latvia,  Lithuania,  Norway,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of symptomatic Venous Thromboembolisms and death from all causes		12 days	No
Secondary	Incidence of all Venous Thromboembolic events		Until day 12, during the treatment period, follow-up period and entire study period	No
Secondary	Incidence of Bleeding events		During the treatment period, follow-up period and entire study period	Yes

External Links

•   Link to Results on JAPIC