Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in … (NCT05968430) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
United States, Australia, Bulgaria1,076 participantsStarted 2023-07-14
Plain-language summary
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent signed by the participant, obtained before any study-related assessment is performed
. At least 18 years of age at the time of signing the informed consent form (ICF)
. 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
. 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
. Willing and able to comply with the study instructions and attend all scheduled study visits
. Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed
Exclusion criteria
. Women who are pregnant, plan to become pregnant, or are breast-feeding
. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
. In the opinion of the Investigator, any condition that will preclude participation in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an open-label extension study, meaning everyone knows they're getting lorundrostat rather than a placebo, what does that tell us about what's already been learned about this drug's safety in the earlier Phase 3 study, and how might that affect my understanding of the risks?
2This trial is no longer actively enrolling new participants — does that mean there's any chance I could still be considered, or should we focus on finding other options for managing my hypertension?
3The study is measuring changes in automated office blood pressure over time, including a 'return to washout' substudy — can you explain what that means for how my blood pressure would be monitored, and what happens if it becomes dangerously high during that period?
4Lorundrostat is being studied for hypertension, which can often be managed with existing medications — given where my blood pressure currently stands, would standard treatments be a more appropriate first step before considering an investigational drug like this?
5Since this is a Phase 3 extension study focused on long-term safety and tolerability, what side effects have been reported so far with lorundrostat that I should be aware of before deciding whether this kind of study would be worth discussing further with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from MLS-101-301 baseline automated office blood pressure
Timeframe: Week 36
2
Change at MLS-101-901 Week 16 (RTW Week 4) from MLS 101-901 Week 12 (RTW substudy baseline) in AOBP SBP in subjects enrolled in RTW