check_circleStudy Completed
Venous thromboembolism
Bayer Identifier:
14398
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Dose-confirmatory bridging study in total knee replacement
Trial purpose
The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total knee replacement (TKR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.
Key Participants Requirements
Sex
BothAge
20 - N/ATrial summary
Enrollment Goal
302Trial Dates
October 2010 - June 2011Phase
Phase 3Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Asahikawa, 078-8237, Japan | |
Completed | Hakodate, 040-8611, Japan | |
Completed | Koriyama, 963-8501, Japan | |
Completed | Kawanuma, 969-6593, Japan | |
Completed | Tsukuba, 305-0854, Japan | |
Completed | Saitama, 336-8522, Japan | |
Completed | Matsudo, 271-8511, Japan | |
Completed | Nerima-ku, 177-8521, Japan | |
Completed | Adachi, 121-0064, Japan | |
Completed | Iida, 395-8505, Japan | |
Completed | Nagoya, 455-8530, Japan | |
Completed | Kyoto, 602-8026, Japan | |
Completed | Osaka, 530-0012, Japan | |
Completed | Osaka, 558-8558, Japan | |
Completed | Takatsuki, 569-1192, Japan | |
Completed | Hirakata, 573-8511, Japan | |
Completed | Sakai, 599-8271, Japan | |
Completed | Osakasayama, 589-8511, Japan | |
Completed | Kishiwada, 596-8522, Japan | |
Completed | Kishiwada, 596-8501, Japan | |
Completed | Izumisano, 598-8577, Japan | |
Completed | Izumi, 594-0071, Japan | |
Completed | Kobe, 657-0068, Japan | |
Completed | Nishinomiya, 663-8501, Japan | |
Completed | Kakogawa, 675-8545, Japan | |
Completed | Fukuoka, 813-0017, Japan | |
Completed | Fukuoka, 819-8551, Japan | |
Completed | Saga, 849-8501, Japan | |
Completed | Sasebo, 857-8575, Japan | |
Completed | Tomigusuku, 901-0243, Japan | |
Completed | Toyama, 930-8550, Japan | |
Completed | Matsuyama, 790-8524, Japan | |
Completed | Sapporo, 060-8648, Japan |
Primary Outcome
- A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causesdate_rangeTime Frame:up to Day 13 (±2 days)enhanced_encryptionNoSafety Issue:
- Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)date_rangeTime Frame:from the first intake of study medication to no later than 2 days after the last intake of study drugenhanced_encryptionYesSafety Issue:
Secondary Outcome
- deep vein thrombosis (total, proximal, distal)date_rangeTime Frame:up to Day 13 (±2 days)enhanced_encryptionNoSafety Issue:
- symptomatic venous thromboembolismdate_rangeTime Frame:up to Day 13 (±2 days)enhanced_encryptionNoSafety Issue:
- major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)date_rangeTime Frame:up to Day 13 (±2 days)enhanced_encryptionNoSafety Issue:
- symptomatic venous thromboembolismdate_rangeTime Frame:within 30 days after stop of treatment with study drugenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4