Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots.
- Conditions
- Health Condition 1: null- Acute symptomatic proximal deep-vein thrombosis and/or symptomatic pulmonary embolism
- Registration Number
- CTRI/2010/091/000317
- Lead Sponsor
- Daiichi Sankyo Pharma Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7500
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method