All studies
Active not recruitingPHASE3INTERVENTIONAL

Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension

This research is an 'open-label extension' study, meaning everyone involved knows they are receiving the active medicine, lorundrostat, for high blood pressure. It's for people who have already participated in an earlier study with this medicine. The main goals are to see how safe it is, how well it works, and if people can tolerate it over a longer time. This type of study helps researchers understand the long-term effects of a medicine. There's also an optional part where some participants might temporarily stop the medicine to see what happens. The study lasts about a year, with an optional longer period until the medicine is approved or the trial ends.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Mineralys Therapeutics Inc.
Enrolment target
1,076
Start
14 Jul 2023
Estimated completion
01 Dec 2026

What is this study about?

This study is a continuation for people who have already taken part in a previous research trial looking at a medicine called lorundrostat for high blood pressure. High blood pressure, also known as hypertension, means your blood is pushing too hard against your artery walls, which can lead to serious health problems if not managed. This new medicine aims to help control blood pressure more effectively.

Because you've already been involved in an earlier study, this new phase allows researchers to gather more information over a longer period. It's called an "open-label" study because both you and the research team will know you are receiving the active medicine, lorundrostat. The main purpose is to carefully watch how safe the medicine is, how well it keeps your blood pressure under control, and if you have any side effects from taking it long-term. This extended look is very important for understanding the full picture of a new treatment.

Gathering this long-term information helps medical experts decide if the medicine is a good option for people with high blood pressure in the future. There's also an optional extra part of the study where some participants might temporarily stop taking the medicine. This helps researchers understand how the body reacts when the medication is paused. Ultimately, the goal is to find better ways to manage high blood pressure and improve people's health.

Key takeaways

  • This study evaluates a blood pressure medicine called lorundrostat for the long term.
  • It's for people who have already taken part in an earlier study with this medicine.
  • The study aims to understand the medicine's safety, effectiveness, and how well people tolerate it.
  • It involves regular clinic visits and taking the study medicine for about a year, with optional longer participation.
  • You can stop participating at any time.
  • All study medicine and care are provided free of charge.

Who may be eligible?

This study is for adults aged 18 or over. To join, you must have already taken part in an earlier study involving lorundrostat for high blood pressure and met all the requirements to move into this new phase. You'll need to sign a consent form to show you understand and agree to take part.

If you're a woman who could become pregnant, or a man whose partner could become pregnant, you'll need to agree to use reliable contraception during the study and for a short time afterwards. You also need to be able to follow the study instructions and attend all your scheduled appointments.

You cannot join this study if you are pregnant, planning to become pregnant, or breastfeeding. You also can't take part if you're using certain other medications that would interfere with the study, or if the study doctor believes there's any reason you shouldn't participate. There are also specific rules for joining the optional temporary treatment withdrawal part of the study, including consistently taking your medicine during the first 12 weeks.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you participated in a previous lorundrostat study for high blood pressure?
  3. Are you able to attend all clinic visits and follow study instructions?
  4. Are you NOT pregnant, planning to become pregnant, or breastfeeding?
  5. Are you willing to use reliable contraception if needed?
  6. Are you NOT taking medications that would interfere with the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about 52 weeks, which is roughly a year. After this, there will be a two-week period where the research team will check on your safety one last time. You'll attend regular visits to the clinic where you'll have check-ups, and the research team will assess your health and response to the medicine.

During this time, you will be taking the study medicine, lorundrostat. You'll receive clear instructions on how to take it. There's also an optional extra period, which you can choose to join after the main year, where you might continue taking the medicine until it's approved for general use or until the study finishes. Some participants might also be asked to take part in an optional, temporary withdrawal from the medicine to see how their body reacts.

Potential risks and benefits

Participating in this study might offer a potential benefit of continuing to receive a medicine that could help manage your blood pressure. However, it's important to remember that this is a research study, and there's no guarantee the medicine will be effective for you. Like all medicines, lorundrostat may have side effects, and some may be unexpected. The research team will carefully monitor you for any potential risks or side effects throughout the study. You will receive detailed information about known side effects in the consent form. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (177)

  • Accel Research Sites (ARS) - Birmingham Clinical Research Unit
    Verified postcode
    Birmingham, United States
  • G & L Research LLC
    Verified postcode
    Foley, United States
  • Chandler Clinical Trials
    Verified postcode
    Chandler, United States
  • Arizona Kidney
    Verified postcode
    Glendale, United States
  • AKDHC Medical Research Services, AZ
    Verified postcode
    Phoenix, United States
  • Noble Clinical Research
    Verified postcode
    Tucson, United States
  • Del Sol Research Management, LLC
    Verified postcode
    Tucson, United States
  • Entertainment Medical Group, Inc
    Verified postcode
    Beverly Hills, United States
  • CA Institute of Renal Research, CA
    Verified postcode
    Chula Vista, United States
  • Amicis Research Center - Vacaville
    Verified postcode
    Fairfield, United States
  • Amicis Research Center - Granada Hills
    Verified postcode
    Granada Hills, United States
  • Marvel Clinical Research 002, LLC
    Verified postcode
    Huntington Beach, United States

Common questions

What is an 'open-label' study?

In an open-label study, both you and the study team know which medicine you are receiving. There are no 'dummy' or placebo treatments in this type of study.

Why is this study only for people from previous trials?

This is an 'extension' study, designed to gather more long-term information on a medicine that people have already started taking in an earlier research study.

Will I have to pay for the medicine?

No, all study-related medicine will be provided to you free of charge during the study.

What happens if I want to stop taking part?

You are free to leave the study at any time and for any reason. Your decision will not affect your usual medical care.

What is high blood pressure?

High blood pressure is when the force of your blood pushing against your artery walls is consistently too high. It can lead to serious health problems like heart attacks or strokes if not managed.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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