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2種類の異なる用量のアベンシグアトが、肝硬変および門脈(肝臓につながる主要な血管)の高血圧患者に効果があるかどうかを検証する研究

基本情報

NCT ID
NCT05161481
ステータス
中止
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
80
治験依頼者名
Boehringer Ingelheim

概要

This study is open to adults with liver cirrhosis and high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called Avenciguat helps people with this condition. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of Avenciguat as tablets twice a day. Participants in the placebo group take placebo as tablets twice a day. Placebo tablets look like Avenciguat tablets but do not contain any medicine. Participants are in the study for about 8 months. During this time, they visit the study site about 14 times. At 3 of the visits, the doctors check the pressure in a liver vein. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The change in blood pressure is then compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

対象疾患

Hypertension, Portal

介入

Avenciguat (BI 685509)(DRUG)
Placebo matching Avenciguat (BI 685509)(DRUG)

実施施設 (6)

Shin-yurigaoka General Hospital

Kanagawa, Kawasaki, Japan

Shin-yurigaoka General Hospital

Kanagawa, Kawasaki, Japan

公立大学法人横浜市立大学附属病院

Kanagawa, Yokohama, Japan

独立行政法人国立病院機構横浜医療センター

Kanagawa, Yokohama, Japan

北里大学病院

Kanagawa, Sagamihara, Japan

大阪公立大学医学部附属病院

Osaka, Osaka, Japan