An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,076
- 试验地点
- 177
- 主要终点
- Change from MLS-101-301 baseline automated office blood pressure
研究概览
简要总结
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
详细描述
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 52 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 may remain on study until marketing authorization or early termination of the trial by the sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Eligible subjects participating in the RTW will receive double-blind treatment with matching placebo. Upon completion, subjects will return to open-label treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
RTW Substudy
lorundrostat or placebo once daily for 4 weeks starting at week 12, in the double-blind randomized treatment withdrawal substudy
Optional for subjects from the MLS-101-301 parent study only
干预措施: Placebo (Drug)
Optional Continuation Period
lorundrostat once daily from week 52 or until marketing authorization or early termination of the trial by the sponsor
干预措施: lorundrostat (Drug)
RTW Substudy
lorundrostat or placebo once daily for 4 weeks starting at week 12, in the double-blind randomized treatment withdrawal substudy
Optional for subjects from the MLS-101-301 parent study only
干预措施: lorundrostat (Drug)
Open-Label Arm
lorundrostat once daily for 52 weeks depending on when the subject enrolled
干预措施: lorundrostat (Drug)
结局指标
主要结局
Change from MLS-101-301 baseline automated office blood pressure
时间窗: Week 36
Change from MLS-101-301 baseline automated office blood pressure (AOBP) systolic blood pressure (SBP) at MLS-101-901 Week 36 in subjects who were enrolled in the lorundrostat arms of MLS-101-301 and were not assigned to the placebo arm of the MLS-101-901 RTW substudy
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
时间窗: Week 16
次要结局
未报告次要终点