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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06139328
Other study ID # 1478-0002
Secondary ID U1111-1291-63202
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 24, 2023
Est. completion date March 15, 2027

Study information

Verified date June 2024
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is open to adults aged 18 and over who have just had a heart attack. The purpose of this study is to find out whether a medicine called BI 765845 helps people who have had a heart attack. The investigators also want to test how well different doses of BI 765845 work and how they are tolerated by people who have had a heart attack. Participants are randomly assigned to receive either BI 765845 or placebo. Placebo treatments look like BI 765845 treatments but do not contain any medicine. Participants are about 4 times as likely to receive BI 765845 than placebo. Participants are in the study for 3 months. During this time, they visit the study site 7 times and get 3 phone calls from the site staff. At the visits, the doctors use clinical tests to check the health of the heart. The results are compared between the BI 765845 and placebo groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BI 765845
BI 765845
Placebo matching BI 765845
Placebo matching BI 765845

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Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Australia,  Canada,  Germany,  Hungary,  Italy,  Korea, Republic of,  New Zealand,  Poland,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Infarct size measured as the percentage of left ventricular mass that is infarcted as detected using late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR) At Day 5
Secondary Infarct size measured as the percentage of left ventricular mass that is infarcted as detected using Late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR) At Day 90
Secondary Difference in myocardial Infarct size (IS) At Day 5 and Day 90
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