A Phase IIa, multi-center, open-label, dose ranging study of the efficacy, safety, and tolerability of oral DU-176b administered once or twice daily in the treatment of adult patients undergoing total hip arthroplasty.

Daiichi Medical Research Inc0 个研究点目标入组 402 人开始时间: 2005年2月28日最近更新: 2012年5月1日

试验速览

暂无简介。

•Patients 18 years of age or greater scheduled for elective unilateral total hip replacement surgery (inclusing revisions).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Age less than 18 years.
•Bleeding or coagulation disorders and increased risk of thromboembolic events.
•Patients with a range of conditions, or recent history, suggestive of an increased risk of bleeding.
•Uncontrolled hypertension BP>180/100 mmHg.
•Body weight outside the range 50 to 110 Kg.
•Anticoagulant therapy in previous 3 days; treatment with vitamin K antagonist; proton pump inhibitors or antacids; NSAIDs with long half life.
•Any contraindications to venography.
•History of venous thromboembolism.
•Impaired hepatic function.
•Spinal anaesthesia with prolonged bleeding from puncture site.
•Immunocompromised patients.
•Patients unlikely to be able to complete the protocol.

发起方

Daiichi Medical Research Inc