What is the Purpose of this Study?
This study focuses on individuals who have high blood pressure that is not well-controlled with their current medications (also known as uncontrolled hypertension) and who have received an experimental drug called MLS-101 or lorundrostat in a previous study. The purpose of the study is to assess the blood pressure-lowering effect of lorundrostat in combination with approved medications used for treating high blood pressure and to determine whether lorundrostat is well-tolerated in the long-term in people with uncontrolled hypertension. Lorundrostat is an experimental drug that blocks the production of aldosterone, which is a hormone that can increase blood pressure when its levels are high. Previous studies suggest that it may be a potential treatment for people with uncontrolled hypertension. In addition to receiving lorundrostat, participants will undergo blood draws, urinalysis, electrocardiograms (ECGs) and physical exams.
Eligibility
- 1. Written informed consent signed by the participant, obtained before any study-related assessment is performed
- 2. At least 18 years of age at the time of signing the informed consent form (ICF)
- 3. Completed the EoT or EoS Visit (as applicable) in a lorundrostat study with the option of transitioning to the OLE study, in accordance with the parent study protocol
- 4. Fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use an acceptable method of contraception from study entry to 28 days after the last dose of study drug
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, EFFICACY, AND TOLERABILITY OF LORUNDROSTAT IN SUBJECTS WITH UNCONTROLLED HYPERTENSION