Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153693
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-11-17
Brief Title:
Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension
Sponsor:
Mineralys Therapeutics Inc
Organization:
Mineralys Therapeutics Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Parallel Arm Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat an aldosterone synthase inhibitor in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive AHT medications
Detailed Description:
This study is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat an aldosterone synthase inhibitor in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive AHT medications one of which must be a thiazide or thiazide-like diuretic
The study consists of a 2-week screening period with a 2-week single-blind run-in period followed by a 12-week randomized double-blind placebo-controlled parallel arm period Following the randomized period subjects will be offered an opportunity to participate in an open-label extension OLE study Any subject electing to not participate in the OLE will undergo an end of study EoS visit which will occur after end of treatment EoT to complete their participation in the study
The study consists of a 2-week screening period with a 2-week single-blind run-in period followed by a 12-week randomized double-blind placebo-controlled parallel arm period Following the randomized period subjects will be offered an opportunity to participate in an open-label extension OLE study Any subject electing to not participate in the OLE will undergo an end of study EoS visit which will occur after end of treatment EoT to complete their participation in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None