What is the Purpose of this Study?
The purpose of this study is to assess the blood pressure lowering effect of an experimental drug called lorundrostat (MLS 101) in combination with medications (that are approved by the U.S. Food and Drug Administration-FDA) used for treating high blood pressure in people with uncontrolled hypertension. Uncontrolled hypertension is a condition in which individuals have high blood pressure that is not well-controlled with medications. Lorundrostat blocks the production of aldosterone, which is a hormone that can increase blood pressure when its levels are high. Researchers will evaluate how long the drug stays detectable in the body and how it may affect other disease markers (blood tests that indicate a person’s risk for a disease). Participants will be randomly assigned to receive either lorundrostat or placebo (inactive substance), in addition to 2 or 3 FDA-approved medications used for treating high blood pressure. Patients will also be asked to complete assessments, such as urine and blood tests, measurements of blood pressure, and medications reviews.
Eligibility
- 1. At least 18 years of age at the time of signing the informed consent form
- 2. At Screening: AOBP SBP of 140-180 mmHg and AOBP DBP of 65-110 mmHg, or AOBP DBP of 90-110 mmHg
- 3. 24-hour average ABPM SBP of 130-180 mmHg or 24-hour average ABPM DBP \>80 mmHg
- 4. Taking between 2 and 5 AHT medications, inclusive, at Screening visit.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL ARM, MULTICENTER, PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LORUNDROSTAT IN SUBJECTS WITH UNCONTROLLED HYPERTENSION ON A STANDARDIZED MEDICATION REGIMEN