Status:
COMPLETED
Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension
Lead Sponsor:
Mineralys Therapeutics Inc.
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-hype...
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 ant...
Eligibility Criteria
Inclusion
- At least 18 years of age at the time of signing the informed consent form (ICF)
- At Screening and Randomization: AOBP SBP of ≥135 and ≤180 mmHg plus AOBP DBP of ≥65 and ≤110 mmHg, or AOBP DBP of ≥90 and ≤110 mmHg
- Taking between 2 and 5 AHT medications,
- History of hypertension lasting at least 6 months prior to Screening
- Body mass index (BMI) of ≥18 kg/m2 at Screening
Exclusion
- Women who are pregnant, plan to become pregnant, or are breastfeeding
- Participation in a study involving any investigational device or small-molecule drug within 4 weeks or 6 months for biologic (antibody) drugs prior to the Screening Visit
- eGFR \<45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- Serum potassium \>5.0 mmol/L at Screening or \>4.8 mmol/L at Randomization
- Serum sodium \<135 mmol/L (corrected for hyperglycemia) at Screening.
- History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2025
Estimated Enrollment :
1083 Patients enrolled
Trial Details
Trial ID
NCT06153693
Start Date
November 22 2023
End Date
January 24 2025
Last Update
December 11 2025
Active Locations (184)
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1
Advanced Cardiovascular, LLC - Alexander City Office
Alexander City, Alabama, United States, 35010
2
Central Research Associates, Inc
Birmingham, Alabama, United States, 35205
3
Cardiology, P.C.
Birmingham, Alabama, United States, 35211-1309
4
Synexus (Radiant Research, Inc) - Alabama - Simon Williamson Clinic Location
Birmingham, Alabama, United States, 35211