check_circleStudy Completed
Deep vein thrombosis
Bayer Identifier:
14568
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Venous thromboembolism (VTE) treatment study in Japanese deep vein thrombosis (DVT) patients
Trial purpose
The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.
Key Participants Requirements
Sex
BothAge
20 - N/ATrial summary
Enrollment Goal
60Trial Dates
March 2012 - January 2014Phase
Phase 3Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Sapporo, 006-8555, Japan | |
Completed | Itabashi-ku, 173-8610, Japan | |
Completed | Meguro-ku, 152-8902, Japan | |
Completed | Yokohama, 245-8575, Japan | |
Completed | Toyoake, 470-1192, Japan | |
Completed | Osakasayama, 589-8511, Japan | |
Completed | Otake, 739-0696, Japan | |
Completed | Maebashi, 371-8511, Japan | |
Completed | Bunkyo-ku, 113-8655, Japan | |
Completed | Niigata, 951-8520, Japan | |
Completed | Kanazawa, 920-8650, Japan | |
Completed | Kahoku-gun, 920-0293, Japan | |
Completed | Tsu, 514-8507, Japan | |
Completed | Osaka, 530-8480, Japan | |
Completed | Kumamoto, 862-8505, Japan | |
Completed | Aomori, 030-8553, Japan | |
Terminated | Suita, 565-8565, Japan | |
Terminated | Shinagawa, 141-8625, Japan | |
Completed | Sakura, 285-8741, Japan | |
Completed | Chuoku, 104-8560, Japan | |
Completed | Shinjuku-ku, 162-8655, Japan | |
Completed | Shizuoka, 424-8636, Japan | |
Completed | Osaka, 537-8511, Japan | |
Completed | Tokushima, 770-8503, Japan | |
Completed | Wakayama, 640-8158, Japan | |
Completed | Sasebo, 857-8511, Japan | |
Completed | Fukuoka, 810-0001, Japan | |
Completed | Takarazuka, 665-0827, Japan | |
Completed | Okayama, 701-1192, Japan |
Primary Outcome
- Number of participants with newly onset of symptomatic venous thromboembolism (VTE)date_rangeTime Frame:Up to 12 monthsenhanced_encryptionNoSafety Issue:
- Number of clinically relevant bleedingsdate_rangeTime Frame:Up to 2 days after last doseenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Number of participants with improvement in thrombotic burdendate_rangeTime Frame:At week 3enhanced_encryptionNoSafety Issue:
- Number of participants with deterioration in thrombotic burdendate_rangeTime Frame:Up to 12 monthsenhanced_encryptionNoSafety Issue:
- Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombusdate_rangeTime Frame:Up to 12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4