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Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension
Sponsor: Mineralys Therapeutics Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1083
Start Date
2023-11-22
Completion Date
2025-01-24
Last Updated
2026-05-01
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placebo once daily (QD) for 12 weeks
lorundrostat Dose 1
50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
lorundrostat Dose 2
50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria
Locations (184)
Advanced Cardiovascular, LLC - Alexander City Office
Alexander City, Alabama, United States
Central Research Associates, Inc
Birmingham, Alabama, United States
Cardiology, P.C.
Birmingham, Alabama, United States
Synexus (Radiant Research, Inc) - Alabama - Simon Williamson Clinic Location
Birmingham, Alabama, United States
G & L Research LLC - Foley
Foley, Alabama, United States
Accel Research Sites (ARS) - Birmingham Clinical Research Unit
Vestavia Hills, Alabama, United States
Del Sol Research
Tucson, Arizona, United States
Entertainment Medical Group, Inc.
Beverly Hills, California, United States
Amicis Research Center - Granada Hills
Granada Hills, California, United States
Amicis Research Center - Northridge
Granada Hills, California, United States
Marvel Clinical Research, LLC
Huntington Beach, California, United States
Amicis Research Center
Northridge, California, United States
Pasadena Clinical Trials
Pasadena, California, United States
Empire Clinical Research (ECR)
Pomona, California, United States
Clinical Trials Research (CTR) - Sacramento
Sacramento, California, United States
North America Research Institute
San Dimas, California, United States
Amicis Research Center - Valencia
Valencia, California, United States
CMR of Greater New Haven
Hamden, Connecticut, United States
Chase Medical Research, LLC - Hamden
Waterbury, Connecticut, United States
Indago Research and Health Center
Hialeah, Florida, United States
Clinical Neuroscience Solutions (CNS Healthcare) - Jacksonville
Jacksonville, Florida, United States
Nuovida Research Center Corp
Miami, Florida, United States
Clinical Neuroscience Solutions (CNS Healthcare) - Orlando Research Center
Orlando, Florida, United States
AES Orlando
Orlando, Florida, United States
Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
Pembroke Pines, Florida, United States
Pines Care Research Center, LLC
Pembroke Pines, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Clinical Research of West Florida (CRWF) - Clearwater
Tampa, Florida, United States
AES The Villages
The Villages, Florida, United States
Morehouse School of Medicine (MSM)
Atlanta, Georgia, United States
ClinCept, LLC
Columbus, Georgia, United States
Accel Research Sites- Decatur
Decatur, Georgia, United States
Georgia Clinical Research Center, Inc
Lawrenceville, Georgia, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Rocky Mountain Diabetes Center
Idaho Falls, Idaho, United States
Solaris Clinical Research (SCR)
Meridian, Idaho, United States
Synexus (Radiant Research, Inc) - Chicago
Chicago, Illinois, United States
Healthcare Research Network-Chicago, Illinois (Flossmoor) Location
Flossmoor, Illinois, United States
Koch Family Medicine, S.C.
Morton, Illinois, United States
Southern Illinois University School of Medicine - SIU Clinics - SIU Internal Medicine
Springfield, Illinois, United States
Investigators Research Group LLC
Brownsburg, Indiana, United States
Franciscan Physician Network
Indianapolis, Indiana, United States
ASHA Clinical Research- Munster, LLC
Munster, Indiana, United States
Synexus (Radiant Research, Inc) - Evansville
Newburgh, Indiana, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, United States
Tulane Doctors - Heart & Vascular - Metairie
New Orleans, Louisiana, United States
The Alliance for Multispecialty Research LLC (AMR) - Louisiana
New Orleans, Louisiana, United States
Northwest Louisiana Nephrology, LLC - Shreveport
Shreveport, Louisiana, United States
Grace Research, LLC
Shreveport, Louisiana, United States
Boston Clinical Trials (BCT)
Boston, Massachusetts, United States
ActivMed Practices and Research
Methuen, Massachusetts, United States
Hattiesburg Clinic - Medisync Clinical Research
Petal, Mississippi, United States
Healthcare Research Network-Hazelwood
Hazelwood, Missouri, United States
Clinical Research Consultants (CRC) - Kansas City
Kansas City, Missouri, United States
Quality Clinical Research Inc. (QCR) - Omaha
Omaha, Nebraska, United States
Synexus (Radiant Research, Inc) - Nevada - Rita B. Chuang, MD
Henderson, Nevada, United States
Sierra Clinical Research-Las Vegas
Las Vegas, Nevada, United States
Renown Regional Medical Center (Washoe Medical Center)
Reno, Nevada, United States
Synexus (Radiant Research, Inc) - New York
Jamaica, New York, United States
North Shore Diabetes and Endocrine Associates (NSDEA) - New Hyde Park
New Hyde Park, New York, United States
Columbia University
New York, New York, United States
Randolph Health Internal Medicine/ Triad Internal Medicine
Asheboro, North Carolina, United States
East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location
Greenville, North Carolina, United States
Physicians East, P.A. - Endocrinology
Greenville, North Carolina, United States
Carteret Medical Group - Morehead City
Morehead City, North Carolina, United States
Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC) (DEC)
New Bern, North Carolina, United States
Diabetes & Endocrinology Associates of Stark County
Canton, Ohio, United States
Lynn Institute of Norman (LION Research)
Norman, Oklahoma, United States
Valley Kidney Specialists PC - Allentown Cedar Crest
Bethlehem, Pennsylvania, United States
Preferred Primary Care Physicians - Pleasant Hills - Curry Hollow Rd Location
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians (PPCP) - Uniontown - Jacob Murphy Lane Location
Uniontown, Pennsylvania, United States
Chattanooga Medical Research (CMR), LLC
Chattanooga, Tennessee, United States
The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group)
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
Punzi Medical Center and Trinity Hypertension Research Institute
Carrollton, Texas, United States
AES Dallas Fort Worth
Dallas, Texas, United States
Synergy Groups Medical
Houston, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Discovery Clinical Trials (DCT) - McAllen
McAllen, Texas, United States
Synergy Groups Medical - Missouri City
Missouri City, Texas, United States
North Texas Family Medicine (NTFM) - Plano Office
Plano, Texas, United States
Sun Research Institute (SRI) - San Antonio
San Antonio, Texas, United States
Discovery Clinical Trials (DCT) - San Antonio
San Antonio, Texas, United States
Global AES - Salt Lake City
Salt Lake City, Utah, United States
Velocity Clinical Research - Salt Lake City (Advanced Clinical Research)
West Jordan, Utah, United States
Burke Internal Medicine
Burke, Virginia, United States
Eastern VA Medical School
Norfolk, Virginia, United States
Castle Hill Medical Centre
Castle Hill, New South Wales, Australia
Renal Research - Gosford
Gosford, New South Wales, Australia
University of Newcastle - John Hunter Hospital (JHH)
Waratah, New South Wales, Australia
University of the Sunshine Coast - Clinical Trials Centre
Sippy Downs, Queensland, Australia
South Coast Renal
Southport, Queensland, Australia
AusTrials - Taringa
Taringa, Queensland, Australia
AusTrials - Wellers Hill
Taringa, Queensland, Australia
Fusion Clinical Research
Adelaide, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Dobney Hypertension Centre/ Royal Perth Hospital
Perth, Western Australia, Australia
Austin Health - Heidelberg Repatriation Hospital
Heidelberg Heights, Australia
AusTrials - Sunshine
St Albans, Australia
Medical Center New Polyclinic Gabrovo Ltd.
Gabrovo, Bulgaria