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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00252005 |
The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.
Condition | Intervention | Phase |
---|---|---|
Deep-Vein Thrombosis |
Drug: Apixaban |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Protocol CV185017: A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic Deep-Vein Thrombosis |
Estimated Enrollment: | 520 |
Study Start Date: | November 2005 |
Study Completion Date: | February 2007 |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea for 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using oral, implanted or, injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential. WOCBP must have negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) within 24 hours prior to the start of study medication.
Exclusion Criteria:
NOTE: topical azole antifungal agents are permitted.
Study ID Numbers: | CV185-017 |
Study First Received: | November 9, 2005 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00252005 |
Health Authority: | United States: Food and Drug Administration |
Heparin, Low-Molecular-Weight Vascular Diseases Fondaparinux Thrombosis Org 31540 Calcium heparin Body Weight |
Embolism and Thrombosis Embolism Vitamin K Venous Thrombosis Heparin Antithrombin III |
Serine Proteinase Inhibitors Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Enzyme Inhibitors Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions Protease Inhibitors |