CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
Apixaban +2 moredrug
Likely dose
Apixaban 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01780987
NCT01780987Phase 3Completed
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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

Pfizer·interventional·Posted Jan 31, 2013·Updated Jun 23, 2016

In Brief

A Phase 3 clinical trial evaluating Apixaban, Unfractionated Heparin (UFH), and 1 other intervention for Deep Vein Thrombosis and Pulmonary Embolism. Completed, enrolled 80 participants across 20 sites.

Detailed Summary

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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDeep Vein Thrombosis, Pulmonary Embolism
CountriesJapan
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2013
Enrollment StartJan 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.4 years ago

Interventions

Apixabandrug

10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)

Unfractionated Heparin (UFH)drug

Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more

Warfarindrug

Dosing for 24 weeks to target INR range between 1.5-2.5