Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients
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ClinicalTrials.gov Identifier: NCT01516814 |
Recruitment Status
:
Completed
First Posted
: January 25, 2012
Last Update Posted
: January 23, 2017
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Sponsor:
Bayer
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
Tracking Information | ||||
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First Submitted Date ICMJE | January 20, 2012 | |||
First Posted Date ICMJE | January 25, 2012 | |||
Last Update Posted Date | January 23, 2017 | |||
Study Start Date ICMJE | February 2012 | |||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01516814 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients | |||
Official Title ICMJE | Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis | |||
Brief Summary | The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Pulmonary Embolism | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
40 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | November 2013 | |||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01516814 | |||
Other Study ID Numbers ICMJE | 15960 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bayer | |||
Study Sponsor ICMJE | Bayer | |||
Collaborators ICMJE | Janssen Research & Development, LLC | |||
Investigators ICMJE |
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PRS Account | Bayer | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |