Open-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension
Open-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension
ClinicalTrials.gov ID: NCT05968430
Sponsor: Mineralys Therapeutics Inc.
Information provided by: Mineralys Therapeutics Inc. (Responsible Party)
Last Update Posted: 2023-10-10
Brief Summary:
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.
Detailed Description:
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.
The study consists of an open-label dose treatment period of 48 weeks, followed by a 4-week double-blind randomized treatment withdrawal sub-study. The study will conclude with a 2-week wash-out period. To be eligible, subjects must complete the double-blind treatment phase of a respective parent study (including, but not limited to MLS-101-202 and MLS-101-301) and agree to transition immediately to this open-label extension (OLE) study (ie, will not participate in the end of study observation period of the parent study).
The study will be conducted at approximately 200 centers.
Intervention / Treatment:
- Drug: lorundrostat
- Drug: lorundrostat
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2023-07-14 |
| Primary Completion (Estimated) | 2025-12 |
| Study Completion (Estimated) |
2025-12
|
| Enrollment (Estimated) | 900 |
| Study Type | Interventional |
| Phase | Phase 2 Phase 3 |
| Other Study ID Numbers |
MLS-101-901 |