選択的全膝関節置換術を受ける患者における静脈内投与JNJ-64179375と経口アピキサバンの安全性および有効性を評価する研究

基本情報

NCT ID

NCT03251482

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

308

治験依頼者名

Janssen Research & Development, LLC

概要

The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis \[DVT\] \[asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic\], nonfatal pulmonary embolism \[PE\], or any death).

対象疾患

介入

依頼者（Sponsor）

実施施設 (12)