PER-119-08
Completed
未知
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
BRISTOL MYERS SQUIBB PERU S.A.,0 sites112 target enrollmentDecember 2, 2008
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- I809
- Sponsor
- BRISTOL MYERS SQUIBB PERU S.A.,
- Enrollment
- 112
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must be willing and able to give written informed consent. Consent to participate in the study must be obtained before selection.
- •Hospitalized patients due to congestive heart failure, acute respiratory failure or infection (without septic shock), acute rheumatic disease or inflammatory bowel disease.
- •Except for patients with congestive heart failure or respiratory failure, patients should have an additional factor, including: 1\) age\> 75 3\) cancer 4\) BMI\> 30 (See Appendix 4 for the BMI Table) 5\) estrogenic hormonal treatment 6\) chronic heart or respiratory failure
- •Patients with planned hospitalization for\> 3 days after randomization
- •Severe or moderate mobility restriction (ie: prostrate or limited to a chair, walk to the bathroom or into the room; see section 6\.9\.1\)
- •Men and women of any race, at least 40 years of age
Exclusion Criteria
- •MEF who do not wish or cannot use an acceptable method to prevent pregnancy during the entire study period.
- •MEF that use a prohibited contraceptive method
- •Pregnant or breastfeeding women
- •Women with a positive pregnancy test at enrollment or before administration of the product under investigation
- •Patients with confirmed VTE
- •Patients with diseases that require ongoing treatment with a parenteral or oral anticoagulant, eg, patients with mechanical valves, atrial fibrillation eligible for warfarin treatment
- •Patients with conditions that require ongoing treatment with parenteral antiplatelet agents or two or more oral antiplatelet agents
- •Active liver disease evidenced through abnormal laboratory test findings (see physical and laboratory findings below)
- •Anemia or thrombocytopenia evidenced by abnormal laboratory test findings (see physical and laboratory findings below)
- •Severe kidney disease evidenced by a creatinine clearance \<30 ml / min estimated using the Cockcroft and Gault method (see Section 6\.3\.1\.2\)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A study to assess the efficacy, safety and tolerability of daily subcutaneous Injections of Elamipretide in subjects with Primary Mitochondrial MyopathyEUCTR2017-002447-15-DEStealth BioTherapeutics Inc.202
Active, not recruiting
Phase 1
A study to assess the efficacy, safety and tolerability of daily subcutaneous Injections of Elamipretide in subjects with Primary Mitochondrial MyopathyPrimary Mitochondrial MyopathyMedDRA version: 20.0Level: PTClassification code 10027710Term: Mitochondrial myopathySystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]EUCTR2017-002447-15-GBStealth BioTherapeutics Inc.202
Active, not recruiting
Phase 1
A study to assess the efficacy, safety and tolerability of daily subcutaneous Injections of Elamipretide in subjects with Primary Mitochondrial MyopathyPrimary Mitochondrial MyopathyMedDRA version: 20.0Level: PTClassification code 10027710Term: Mitochondrial myopathySystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]EUCTR2017-002447-15-DKStealth BioTherapeutics Inc.218
Active, not recruiting
Phase 1
Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)MedDRA version: 20.0Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: HLGTClassification code 10052635Term: Cytoplasmic disorders congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: HLTClassification code 10052637Term: Genetic mitochondrial abnormalities NECSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: PTClassification code 10027710Term: Mitochondrial myopathySystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]EUCTR2021-003907-16-ESStealth BioTherapeutics Inc.130
Active, not recruiting
Phase 1
Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)MedDRA version: 20.0Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: HLGTClassification code 10052635Term: Cytoplasmic disorders congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: HLTClassification code 10052637Term: Genetic mitochondrial abnormalities NECSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]EUCTR2021-003907-16-HUStealth BioTherapeutics Inc.130