MLS-101-901: An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension - MLS-101-901

Mineralys Therapeutics Inc.0 个研究点目标入组 1,170 人开始时间: 2024年4月24日最近更新: 2024年8月21日

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•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 ICF and capable of providing consent, 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 acceptable methods 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, Randomized treatment withdrawal substudy only: Completed participation in the MLS-101-301 parent study, Randomized treatment withdrawal substudy only:Reduction of at least 5 mmHg in AOBP SBP from the MLS-101-301 Randomization Visit value at the MLS-101-901 Week 12 visit

•1.Women who are pregnant, plan to become pregnant, or are breast-feeding, 2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1, 3. In the opinion of the Investigator, any condition that will preclude participation in the study, 4.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

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