Health Condition 1: null- Acute symptomatic proximal deep-vein thrombosis and/or symptomatic pulmonary embolism
Conditions
Interventions
Intervention1: Edoxaban tosylate(DU-176b): Tablet Edoxaban tosylate(DU-176b) for oral use, 30 mg, one or two tablets daily, maximum of 12 months treatment
Control Intervention1: low molecular weight h
Sponsors
Daiichi Sankyo Pharma Development
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No 1) Male or female subjects older than the minimum legal adult age (country specific); 2) Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging; 3) Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE; 2) More than 48 hours pre-treatment with anticoagulant therapy prior to randomization; 3) Calculated CrCL < 30 mL/min; 4) significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) >= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN; 5) patients with active cancer for whom long term treatment with (LMW) heparin is anticipated; 6) active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin; 7) chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs); 8) treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy; 9) concurrent treatment with potent P-gp inhibitors; 10) subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Symptomatic recurrent VTE, i.e., the composite of DVT, non-fatal PE, and fatal PETimepoint: Time Frame: 12 months from time of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| - The composite clinical outcome of symptomatic recurrent DVT, non-fatal symptomatic recurrent PE, and all-cause mortality - Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatmentTimepoint: Time Frame: 12 months from time of randomization | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Republic of Korea, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactSuchela Srivatsa
Quintiles Research (India) Private Limited
Outcome results
None listed