A Phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of oral 220 mg dabigatran etexilate (110 mg on the day of surgery followed by 220 mg once daily) compared to subcutaneous 40 mg enoxaparin once daily for 28-35 days in prevention of venous thromboembolism in patients following primary elective total hip arthroplasty. - RE-NOVATE II

BOEHRINGER ING.0 个研究点目标入组 2,500 人开始时间: 2008年7月15日最近更新: 2012年3月19日

试验速览

暂无简介。

•-Patients scheduled to undergo primary, unilateral, elective total hip arthroplasty. -Male or female 18 years of age or older. -Patients giving written informed consent for study participation.
•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

•-History of bleeding diathesis. -Ongoing treatment for VTE. -Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding) within 6 months of enrolment. -Liver disease expected to have any potential impact on survival (ie, hepatitis B or C, cirrhosis). This does not include Gilbert?s syndrome or hepatitis A with complete recovery. -Known severe renal insufficiency (CrCl <30 ml/min). Note: CrCl should be calculated only if serum creatinine is elevated or renal insufficiency is suspected. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who: a. Are pregnant. b. Are nursing. c. Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device; oral, implantable or injectable contraceptives and surgical sterility.

发起方

BOEHRINGER ING.