EUCTR2006-003674-96-NL
Active, not recruiting
Not Applicable
A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safetyand Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely IllMedical Subjects During and Following Hospitalization.ADOPT: Apixaban Dosing to Optimize Protection from ThrombosisAnd Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date 27-Feb-2007) - ADOPT
ConditionsTotal Venous thromboembolism (VTE), defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT.MedDRA version: 9.1Level: LLTClassification code 10051055Term: Deep vein thrombosisMedDRA version: 9.1Level: LLTClassification code 10037377Term: Pulmonary embolismMedDRA version: 9.1Level: LLTClassification code 10049918Term: Deep venous thrombosis proximal
DrugsClexane
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Venous thromboembolism (VTE), defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT.
- Sponsor
- Bristol Myers Squibb
- Enrollment
- 7502
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Subjects must be willing and able to give written informed consent. Consent to participate in the study must be obtained prior to screening.
- •2\) Subjects hospitalized due to congestive heart failure, acute respiratory failure or with infection (without septic shock), acute rheumatic disorder, or inflammatory bowel
- •3\) Except for subjects with congestive heart failure or respiratory failure, subjects must have one additional factor including:
- •a) age \= 75
- •b) previous documented VTE or history of VTE for which they received anticoagulation for at least 6 weeks
- •d) BMI \= 30 (See Appendix 4 for BMI chart)
- •e) estrogenic hormone therapy
- •f) chronic heart or respiratory failure
- •4\) Expected hospitalization of \= 3 days after randomization
- •5\) Severely or moderately restricted mobility (i.e. bedridden or limited to chair, walking to bathroom or within room; see section 6\.9\.1\)
Exclusion Criteria
- •1\) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period
- •2\) WOCBP using a prohibited contraceptive method
- •3\) Women who are pregnant or breastfeeding
- •4\) Women with a positive pregnancy test on enrollment or prior to investigational
- •product administration
- •5\) Subjects with a confirmed VTE
- •6\) Subjects with diseases requiring ongoing treatment with a parenteral or oral
- •anticoagulant, e.g. subjects with mechanical valves, warfarin eligible atrial fibrillation
- •7\) Subjects with conditions requiring treatment with parenteral or oral antiplatelet agents other than aspirin \= 165 mg/day
Outcomes
Primary Outcomes
Not specified
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Not Applicable
A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safetyand Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely IllMedical Subjects During and Following Hospitalization.ADOPT: Apixaban Dosing to Optimize Protection from ThrombosisAnd Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date 27-Feb-2007)Revised Protocol Number 01 incorporating Amendment 02 and Admin Letter 01 (Version 5.0, dated 25-Jan-2008Protocol Amendment 03 dated 26-Feb-2009Revised Protocol 02 incorporating Amendment 04 version 7.0 dated 26-Feb-2009 - ADOPTTotal Venous thromboembolism (VTE), defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT.MedDRA version: 9.1Level: LLTClassification code 10051055Term: Deep vein thrombosisMedDRA version: 9.1Level: LLTClassification code 10037377Term: Pulmonary embolismMedDRA version: 9.1Level: LLTClassification code 10049918Term: Deep venous thrombosis proximalEUCTR2006-003674-96-HUBristol Myers Squibb7,502
Active, not recruiting
Not Applicable
A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safetyand Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely IllMedical Subjects During and Following Hospitalization.ADOPT: Apixaban Dosing to Optimize Protection from ThrombosisAnd Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date 27-Feb-2007)+ Revised Protocol Number 01 incorporating Amendment 02 and Admin Letter 01 (Version 5.0, dated 25-Jan-2008+ Protocol Amendment 03 dated 26-Feb-2009+ Revised Protocol 02 incorporating Protocol Amendment 04 version 7.0 dated 26-Feb-2009 - ADOPTTotal Venous thromboembolism (VTE), defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT.MedDRA version: 9.1Level: LLTClassification code 10051055Term: Deep vein thrombosisMedDRA version: 9.1Level: LLTClassification code 10037377Term: Pulmonary embolismMedDRA version: 9.1Level: LLTClassification code 10049918Term: Deep venous thrombosis proximalEUCTR2006-003674-96-DKBristol Myers Squibb7,502