Study on the Long-Term Safety and Effectiveness of Lorundrostat for Patients with Uncontrolled and Resistant Hypertension

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What is this study about?

This clinical trial is focused on studying the long-term effects of a medication called Lorundrostat in people with uncontrolled and resistant hypertension, which is a type of high blood pressure that is difficult to manage with standard treatments. The study aims to understand how well Lorundrostat works over time, how safe it is, and how well people can tolerate it. Lorundrostat is taken as a tablet by mouth, and the study will also include a comparison with a placebo to evaluate its effectiveness.

Participants in the study will take Lorundrostat for a period of time to see if it helps maintain lower blood pressure levels. The study will also explore how starting with a dose of 25 mg once daily affects blood pressure and whether it can improve a condition called albuminuria, which involves protein in the urine and can be a sign of kidney problems. The study will include a special part where some participants will stop taking Lorundrostat to see how their blood pressure changes, which helps to understand the medication’s impact better.

The trial is designed to gather information on the long-term safety and effectiveness of Lorundrostat for people with high blood pressure that is hard to control. This information will help determine if Lorundrostat can be a reliable treatment option for managing hypertension in the future. Participants will be monitored throughout the study to ensure their safety and to collect data on how the medication affects their blood pressure and overall health.

1 joining the study

Upon joining the study, the participant will begin taking the medication lorundrostat.

The initial dose is 25 mg taken once daily by mouth.

2 initial treatment phase

During the first 12 weeks, the participant will continue taking lorundrostat daily.

Regular monitoring of blood pressure will occur to assess the medication’s effectiveness.

3 randomized treatment withdrawal (RTW) substudy

Participants who meet specific criteria may enter a substudy where they might receive a placebo instead of lorundrostat.

This phase lasts for 4 weeks, and blood pressure will be closely monitored.

4 long-term treatment phase

After completing the RTW substudy, participants will resume taking lorundrostat daily.

This phase continues until the end of the study, with regular check-ups to monitor safety and effectiveness.

5 end of study

The study is expected to conclude by January 31, 2026.

Final assessments will be conducted to evaluate the long-term effects of lorundrostat on blood pressure.

Who Can Join the Study?

  • The participant must sign a written informed consent form before any study-related activities begin. This means they agree to take part in the study and understand what it involves.
  • The participant must be at least 18 years old at the time of signing the consent form and be able to give their consent.
  • The participant must have completed the End of Treatment (EoT) or End of Study (EoS) visit in a previous lorundrostat study and be eligible to move to the Open-Label Extension (OLE) study, following the rules of the previous study.
  • If the participant is a fertile male or a female who can have children, they and their partners must agree to use acceptable birth control methods from the start of the study until 28 days after the last dose of the study drug.
  • The participant must be willing and able to follow the study instructions and attend all scheduled study visits.
  • For the Randomized Treatment Withdrawal (RTW) substudy only: The participant must sign a separate informed consent form to take part in this specific part of the study before any related activities begin.
  • For the RTW substudy only: The participant must have completed participation in the MLS-101-301 parent study.
  • For the RTW substudy only: The participant must have shown a reduction of at least 5 mmHg in their Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) from the value at the MLS-101-301 Randomization Visit to the value at the MLS-101-901 Week 12 visit. This means their blood pressure must have decreased by at least 5 units.

Who Cannot Join the Study?

  • Patients with uncontrolled and resistant hypertension cannot participate. This means their high blood pressure is not being managed well with current treatments.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Futuremeds Sp. z o.o. Wroclaw Poland

Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
FutureMeds GmbH Berlin Germany
Delta Health Care S.R.L. Bucharest Romania
Centrul Medical Unirea S.R.L. Brasov Romania
Medicali’s S.R.L. Timisoara Romania
Hospital Universitario Virgen De Las Nieves Granada Spain
Medizinisches Versorgungszentrum Jung GbR Deggingen Germany
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Olsztyn Poland
Herzzentrum Leipzig GmbH Leipzig Germany
Etg Neuroscience Sp. z o.o. Warsaw Poland
Hospital Clinico Universitario De Valencia Valencia Spain
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Clinmedica Research sp. z o.o. Skierniewice Poland
Hospital Universitario Reina Sofía Cordoba Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Samodzielny Publiczny Szpital Kliniczny Imienia Andrzeja Mieleckiego Katowice Poland
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Universitaetsklinikum Leipzig AöR Leipzig Germany
Mgatsdv Csjnbq Nru Pwqkatsgvu Gzoicwr Lyvq Gabrovo Bulgaria
Huomddnj Ueyjsjprqvnyu Ds Brvppmh Badajoz Spain
Kvcjyqpxg Ffppnubsp Dxfyido Gqhc Dresden Germany
Daaifzohvt Ayw Crgxyqwnwl Cmhovv 1 Vqqrlc Tujogcm Lrrs Veliko Tirnovo Bulgaria
Aczdfrfw &ybrleq Ifwcequzek pbgftcum &alksitelxuhm Tkvdxowgcwdi Etug Sofia Bulgaria
Cpl dgzfzqvobwkrdi Epagny Metz Tessy France
Mlgjthz Cmwhcp Epmqzo Mllvjr Oak Pleven Bulgaria
Axhmtwpfb Ujc Amsterdam The Netherlands
Azztalm Upnkk Sigmtczfu Llkltu Dd Blullvg Bologna Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
11.08.2024
France France
Not recruiting
11.08.2024
Germany Germany
Not recruiting
11.08.2024
Italy Italy
Not recruiting
11.08.2024
Poland Poland
Not recruiting
11.08.2024
Romania Romania
Not recruiting
11.08.2024
Spain Spain
Not recruiting
11.08.2024
The Netherlands The Netherlands
Not recruiting
11.08.2024

Trial locations

Lorundrostat is a medication being studied for its ability to lower high blood pressure in people whose hypertension is not well controlled or is resistant to treatment. The trial aims to see how well lorundrostat works over a long period and how safe and tolerable it is for patients. The study also looks at how lorundrostat might help improve other health issues related to high blood pressure, such as albuminuria, which is a condition where there is too much protein in the urine.

Investigated diseases:

Uncontrolled and Resistant Hypertension – This condition is characterized by high blood pressure that remains elevated despite the use of multiple antihypertensive medications. Uncontrolled hypertension refers to blood pressure that is not adequately managed, while resistant hypertension is a more severe form where blood pressure remains high despite the use of at least three different types of blood pressure-lowering drugs, including a diuretic. The progression of this condition can lead to persistent high blood pressure, which may increase the risk of complications affecting the heart, kidneys, and other organs. It often requires ongoing monitoring and adjustments in treatment to manage effectively.

Trial ID:
2023-508670-28-00
Protocol code:
MLS-101-901
NCT ID:
NCT05968430
Trial Phase:
Therapeutic confirmatory (Phase III)

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