A Pivotal Study to Evaluate the Efficacy of Lorundrostat (MLS-101) in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

A Pivotal Study to Evaluate the Efficacy of Lorundrostat (MLS-101) in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

This study is a Phase 2 trial to evaluate the blood pressure-lowering effects of lorundrostat (an aldosterone synthase inhibitor), administered on a background of a standardized anti-hypertensive (AHT) medication regimen, in subjects with uncontrolled hypertension. The study consists of a standardized AHT regimen run-in phase with single blind lorundrostat placebo (subject is blinded) followed by a randomized, double-blind, placebo-controlled, parallel arm phase, after which subjects will be offered the opportunity to participate in an open-label extension (OLE) with an initial 4-week randomized double-blind treatment withdrawal phase. Any subject electing to not participate in the OLE will undergo an end of study visit to complete their participation in the study.
The study will be conducted at approximately 60 centers across the United States.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

March 16, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Comments