YM150 vs Enoxparin in patients undergoing hip replacement surgery

• Research type

  Research Study

• Full title

  A Randomised, 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.

• IRAS ID

  12531

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2008-00416-13

• ISRCTN Number

  n/a

• Research summary

  Venous Thromboembolism (VTE) is a common occurrence following total hip replacement and occurs in 45%-57% of patients who undergo total hip replacement surgery without prophylaxis. This study investigates a new drug under development by Astellas Pharma Europe B.V. YM150 has been designed to help reduce the risk of formation of blood clots in veins after hip replacement surgery. This study comparts 4 different dosage groups of YM150 and Enoxaparin, an established injectable treatment for preventing blood clots. YM150 is taken as a tablet instead of an injection like most standard of care drugs. The information collected in this study will be analysed to find out if YM150 is safe and effective compared to enoxaparin. Study assessments include: Physical Examinations, Blood/Urine tests, ECG, Venogram. patients will receive either YM150 15mg twice/day, YM150 30mg twice/day, YM150 30mg once/day, YM150 60mg once/day or Enoxaparin once/day. To maintain the blind of the study, each day all patients will receive a morning dose of two tables and one injection, and an evening dose of one tablet. The daily dose is a combination of active treatment and placebo. The total duration of the study is approximately 9 weeks. Approximately 2000 patients will take part in this study from sites in Europe, Africa, Asia, Australia and North and South America.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/74

• Date of REC Opinion

  22 Jul 2009

• REC opinion

  Further Information Favourable Opinion