Overview

A Study to Test Whether Two Different Doses of BI 685509 Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)

Status:
Not yet recruiting
Trial end date:
2023-11-10
Target enrollment:
Participant gender:
Summary
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 BI 685509 helps people with this condition. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 685509 as tablets twice a day. Participants in the placebo group take placebo as tablets twice a day. Placebo tablets look like BI 685509 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.
Phase:
Phase 2
Details
Lead Sponsor:
Boehringer Ingelheim