Boston Clinical Trials | Boston, MA
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About
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
Full description
The purpose of the study is to evaluate the long-term safety, efficacy, and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension.
This study consists of an open label treatment period of up to 36 or 48-weeks followed by a 2-week safety follow-up period. Eligible subjects for MLS-101-901 are those who were enrolled in one of the eligible parent studies, meet the eligibility criteria for this protocol, and agree, by signing an informed consent form (ICF), to transition to this open label extension (OLE) study at either the end-of-study (EoS) visit or the end-of-treatment (EoT) visit as required in the parent study protocol.
A Randomized Treatment Withdrawal (RTW) substudy will be performed in a subset of subjects meeting eligibility criteria.
Subjects who complete the open label treatment period will be invited to consent to an optional continuation period where they can remain on study until marketing authorization or early termination of the trial by the sponsor.
Enrollment
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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
[Randomized treatment withdrawal substudy only]
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
[Randomized treatment withdrawal substudy only]
Non-compliance with study medication(s) (defined as taking <75% or >125% of the study drug provided) during the first 12 weeks of MLS-101-901
Primary purpose
Allocation
Interventional model
Masking
1,400 participants in 3 patient groups
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Central trial contact
Nicole Brown
Data sourced from clinicaltrials.gov
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