AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01780987
First received: January 29, 2013
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)
| Condition | Intervention | Phase |
|---|---|---|
|
Deep Vein Thrombosis Pulmonary Embolism |
Drug: Apixaban Drug: Unfractionated Heparin (UFH) Drug: Warfarin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Active-Control, Multicenter, Randomized, Open-Label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Major bleeding and Clinically Relevant Non-major bleeding [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- symptomatic VTE or VTE-related death [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- thrombtic burden deterioration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Major bleeeding [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- All bleeding [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Apixaban |
Drug: Apixaban
10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
|
| Active Comparator: UFH/Warfarin |
Drug: Unfractionated Heparin (UFH)
Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more
Drug: Warfarin
Dosing for 24 weeks to target INR range between 1.5-2.5
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Acute symptomatic proximal DVT with evidence of proximal thrombosis
- Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches
Exclusion Criteria:
- Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.
- Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
- Subjects requiring dual anti-platelet therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780987
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Japan | |
| Aichi Medical University Hospital | Recruiting |
| Nagakute, Aichi, Japan | |
| Toho University Sakura Medical Center | Recruiting |
| Sakura, Chiba, Japan | |
| Kokura Memorial Hospital | Recruiting |
| Kitakyusyu, Fukuoka, Japan | |
| Hiroshima General Hospital | Recruiting |
| Hatsukaichi, Hiroshima, Japan | |
| Teine Keijinkai Hospital | Recruiting |
| Sapporo, Hokkaido, Japan | |
| Yokohama Minami Kyousai Hospital | Recruiting |
| Yokohama, Kanagawa, Japan | |
| National Hospital Organization Yokohama Medical Center | Not yet recruiting |
| Yokohama, Kanagawa, Japan | |
| Mie University Hospital | Recruiting |
| Tsu, Mie, Japan | |
| National Hospital Organization Okayama Medical Center | Recruiting |
| Okayama City, Okayama, Japan | |
| Kinki University Hospital | Recruiting |
| Osakasayama, Osaka, Japan | |
| National Cerebral and Cardiovascular Center Hospital | Not yet recruiting |
| Suita-shi, Osaka, Japan | |
| St. Luke's International Hospital | Recruiting |
| Chuo-ku, Tokyo, Japan | |
| Nihon University Itabashi Hospital | Recruiting |
| Itabashi-ku, Tokyo, Japan | |
| Japanese Red Cross Musashino Hospital | Recruiting |
| Musashino, Tokyo, Japan | |
| Tokyo Medical University Hospital | Recruiting |
| Shinjuku-ku, Tokyo, Japan | |
| Fukushima Medical University Hospital | Recruiting |
| Fukushima, Japan | |
| Saiseikai Kumamoto Hospital | Recruiting |
| Kumamoto, Japan | |
| Kumamoto University Hospital | Recruiting |
| Kumamoto, Japan | |
Sponsors and Collaborators
Pfizer
Bristol-Myers Squibb
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01780987 History of Changes |
| Other Study ID Numbers: | B0661024, CV185160 |
| Study First Received: | January 29, 2013 |
| Last Updated: | May 6, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Pfizer:
|
DVT PE VTE |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Calcium heparin |
Heparin Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013