A study to investigate the efficacy, safety, tolerability and pharmacokinetics of PKN605 in part - Clinical Trial
What is the Purpose of this Study?
This study lasts for about 41 weeks. It starts with a screening period, followed by around 6 months of taking either the study medicine or a placebo, and ends with a follow-up visit. People who join will be randomly chosen to get either a low dose or high dose of the medicine called PKN605, or a placebo, which is a pill that does not have any medicine in it.
During the study, participants will go to the clinic regularly. They will wear a heart monitor patch, use a small device at home to check their heart, and have blood tests and other health checks. These tests help doctors learn how the medicine works and if it is safe.
This study is looking at how a medicine called PKN605 works in adults who have a heart condition called atrial fibrillation, or AF. AF causes the heart to beat in an irregular way. To join the study, people must have had at least two episodes of AF, with one happening in the past year.
They must also meet at least one other condition, such as having a certain amount of AF shown on a heart monitor, having a score that shows a higher risk of stroke, having mild heart failure, or having a certain level of a heart-related protein in their blood. People must also be taking medicine to help prevent strokes and have a normal heart rhythm when the study begins.
The study will help doctors learn if PKN605 is safe, how well people can handle it, how it affects the body, and if it helps control AF.
Who Can Participate in the Study?
Adults who are 18 years old or older may be able to join this study if they have had at least two episodes of atrial fibrillation, which is a problem with how the heart beats. One of these episodes must have been recorded in the past year using a heart test like an ECG.
To qualify, participants must also meet at least one other condition. These include having a score that shows a higher risk of stroke, having atrial fibrillation for at least 1% of the time on a heart monitor, having mild and stable heart failure, or having a certain level of a heart-related protein in their blood.
People cannot join the study if they have permanent atrial fibrillation, certain other heart problems, or if they are currently taking medicines that treat irregular heartbeats.
What is Involved?
This study is testing a new medicine called PKN605 to see if it can help people who have atrial fibrillation, which is a problem with how the heart beats. The goal is to find out if the medicine can safely reduce the amount of time people spend in atrial fibrillation and help them feel better. Researchers also want to learn how the medicine moves through the body and how it affects the heart.
Study Details
