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A Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat an aldosterone synthase inhibitor (ASI), administered as an add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.
This study is a Phase 2 trial to evaluate the blood pressure-lowering effects of lorundrostat (an ASI), administered as add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.
The study consists of a standardized AHT regimen run-in period followed by a randomized, double-blind, placebo-controlled, parallel arm period. Following the double-blind period subjects may be offered the opportunity to participate in an open-label extension (OLE) study. Subjects electing to not participate in the OLE will undergo an end of study (EoS) visit approximately 2 weeks after the last dose of study drug to complete their participation in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo once daily for 12 weeks |
|
| Dose 1 | Experimental | lorundrostat Dose 1 once daily for 12 weeks |
|
| Dose 2 | Experimental | lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo once daily for 12 weeks |
| |
| lorundrostat Dose 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) | Baseline (Randomization) to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24-hour average ABPM SBP at Week 4 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo | Baseline to Week 4 | |
| Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 4 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, P.C. - Birmingham | Birmingham | Alabama | 35211 | United States | ||
| University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension Program |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40267417 | Derived | Laffin LJ, Kopjar B, Melgaard C, Wolski K, Ibbitson J, Bhikam S, Weir MR, Ofili EO, Mehra R, Luther JM, Cohen DL, Sarraju A, Wilkinson MJ, Flack JM, Rodman D, Nissen SE; Advance-HTN Investigators. Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension. N Engl J Med. 2025 May 8;392(18):1813-1823. doi: 10.1056/NEJMoa2501440. Epub 2025 Apr 23. |
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| Drug |
lorundrostat Dose 1 once daily for 12 weeks |
|
| lorundrostat Dose 2 | Drug | lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks for subjects who meet prespecified criteria |
|
| at Week 4 |
| Change from baseline in 24-hour average ABPM SBP at Week 4 by obesity status in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo | Baseline to Week 4 |
| Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at Week 4 (within-subjects analysis) | Baseline to Week 12 |
| Change from baseline in 24-hour average ABPM SBP at Week 4, by number of AHT medications in the standardized AHT regimen (2 and 3) in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo | Baseline to Week 4 |
| Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 12 in subjects randomized to lorundrostat (by arm and pooled dosages) compared to subjects randomized to placebo | Baseline to Week 12 |
| Change from baseline in 24-hour average ABPM SBP at Week 12 by obesity status in subjects randomized to lorundrostat (by arm and pooled dosages) compared to subjects randomized to placebo | Baseline to Week 12 |
| Change from baseline in daytime average ABPM SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo | Baseline to Week 4 and Week 12 |
| Change from baseline in AOBP SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg QD (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo | Baseline to Week 4 and Week 12 |
| Change from baseline in nighttime average ABPM SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg QD (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo | Baseline to Week 4 and Week 12 |
| Change from baseline in 24-hour average ABPM SBP at Week 12, in subjects randomized to lorundrostat (pooled dosages) compared to subjects randomized to placebo | Baseline to Week 12 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Chandler Clinical Trials | Chandler | Arizona | 85224 | United States |
| Brown Road Family Medicine | Mesa | Arizona | 85213 | United States |
| Scottsdale Clinical Trials (Elite Clinical Network) | Scottsdale | Arizona | 85260 | United States |
| Fiel Family & Sports Medicine | Tempe | Arizona | 85383 | United States |
| Noble Clinical Research | Tucson | Arizona | 85704 | United States |
| Del Sol Research Management, LLC | Tucson | Arizona | 85715 | United States |
| The Medical Research Group Inc. | Fresno | California | 93720 | United States |
| Marvel Clinical Research | Huntington Beach | California | 92647 | United States |
| University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI) | La Jolla | California | 92037 | United States |
| Clinical Trials Research | Lincoln | California | 95648 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Catalina Research Institute | Montclair | California | 91763 | United States |
| Northridge Clinical Trials | Northridge | California | 91325 | United States |
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
| Triwest Research Associates | San Diego | California | 92108 | United States |
| San Jose Clinical Trials | San Jose | California | 95117 | United States |
| Blue Coast Research Center | Vista | California | 92081 | United States |
| Accelerated Enrollment Solutions (AES)- Vista | Vista | California | 92083 | United States |
| Delta Waves, Inc. | Colorado Springs | Colorado | 80918 | United States |
| CMR of Greater New Haven | Hamden | Connecticut | 06517 | United States |
| Indago Research & Health Center, Inc. | Hialeah | Florida | 33012 | United States |
| Clinical Neuroscience Solutions, Inc (Jacksonville) | Jacksonville | Florida | 32256 | United States |
| Reserka, LLC | Miami | Florida | 33176 | United States |
| Nuovida Research Center Corp | Miami | Florida | 33186 | United States |
| Clinical Neuroscience Solutions, INC. | Orlando | Florida | 32801 | United States |
| Patron Medical - Andres Patron D.O. (Patron Ventures, LLC) | Pembroke | Florida | 33026 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33606 | United States |
| The Pierone Research Institute (Elligo Health Research) | Vero Beach | Florida | 32960 | United States |
| Nephrology Associates, PC - Downtown Augusta | Augusta | Georgia | 30901 | United States |
| Accel Research Sites | Decatur | Georgia | 30030 | United States |
| Georgia Clinical Research, LLC | Lawrenceville | Georgia | 30044 | United States |
| Randomize Now | Peachtree City | Georgia | 30269 | United States |
| Alta Pharmaceutical Research Center | Peachtree Corners | Georgia | 30092 | United States |
| Fellows Research Alliance, Inc | Savannah | Georgia | 31406 | United States |
| Eagle Clinical Research | Chicago | Illinois | 60621 | United States |
| The University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| GenHarp Clinical Solutions | Evergreen Park | Illinois | 60805 | United States |
| Southern Illinois School of Medicine | Springfield | Illinois | 62702 | United States |
| Franciscan Physician Network-Indiana Heart Physicians | Indianapolis | Indiana | 46237 | United States |
| Indiana Clinical Research | Merrillville | Indiana | 46410 | United States |
| The Research Group of Lexington, LLC | Lexington | Kentucky | 40503 | United States |
| Advanced Internal Medicine, PLLC (Elligo Health Research) | Paducah | Kentucky | 42001 | United States |
| Versailles Family Medicine | Versailles | Kentucky | 40383 | United States |
| Cambridge Clinical Trials | Alexandria | Louisiana | 71301 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| ActivMed Practices & Research, LLC | Methuen | Massachusetts | 01844 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| Quality Clinical Research Inc. (QCR) - Omaha | Omaha | Nebraska | 68114 | United States |
| Henderson Clinical Trials | Henderson | Nevada | 89052 | United States |
| Las Vegas Clinical Trials | Las Vegas | Nevada | 89030 | United States |
| Oasis Clinical Trials | Las Vegas | Nevada | 89121 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Seacoast Kidney & Hypertension Specialist | Portsmouth | New Hampshire | 03801 | United States |
| Albany Medical College Div of Community Endocrinology | Albany | New York | 12203 | United States |
| University of Buffalo | Buffalo | New York | 14215 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Marian David, MD, PC (Elligo Health Research) | New York | New York | 11415 | United States |
| Triad Internal Medicine | Asheboro | North Carolina | 27205 | United States |
| Asheville Clinical Trials (Elite Clinical Network) | Asheville | North Carolina | 28803 | United States |
| Duke University Medical Center Heart Center Clinical Research Unit | Durham | North Carolina | 27710 | United States |
| East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location | Greenville | North Carolina | 27834 | United States |
| Lucas Research, Inc. | New Bern | North Carolina | 28557 | United States |
| Iredell Memorial Hospital, Inc (Elligo Health Research) | Statesville | North Carolina | 28677 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| Research Innovations (Elligo Health Research) | Beavercreek | Ohio | 45431 | United States |
| Diabetes and Endocrinology Associates of Stark County, Inc. | Canton | Ohio | 44718 | United States |
| Intrepid Research | Cincinnati | Ohio | 45245 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Centricity Research (Aventiv Research) - Women's Health | Dublin | Ohio | 43016 | United States |
| STAT Research | Springboro | Ohio | 45066 | United States |
| Williamette Valley Clincial Studies | Eugene | Oregon | 97404 | United States |
| AMS Cardiology | Horsham | Pennsylvania | 19044 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Accelerated Enrollment Solutions (AES)- Anderson | Anderson | South Carolina | 29621 | United States |
| WR- Notus Clinical Trials, LLC | Charleston | South Carolina | 29414 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Chattanooga Medical Research | Chattanooga | Tennessee | 37404 | United States |
| Lifedoc Research | Memphis | Tennessee | 38115 | United States |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | 38119 | United States |
| Vanderbilt University Medical Center (VUMC) | Nashville | Tennessee | 37232 | United States |
| Elligo Health Research | Austin | Texas | 78704 | United States |
| Punzi Medical Center | Carrollton | Texas | 75006 | United States |
| David Turbay, MD, PLLC (Elligo Health Research) | El Paso | Texas | 79905 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| Juno Research LLC | Houston | Texas | 77040 | United States |
| Gulf Coast Clinical Research | Houston | Texas | 77070 | United States |
| Medical Colleagues of Texas, LLP (Elligo Health Research) | Katy | Texas | 77450 | United States |
| Synergy Groups Medical - Bissonet Site | Katy | Texas | 77494 | United States |
| PRX Research - Mesquite | Mesquite | Texas | 75149 | United States |
| Medical Colleagues of Texas, LLP (Elligo Health Research) | Paris | Texas | 75462 | United States |
| ACRC Trials | Plano | Texas | 75024 | United States |
| Clinical Investigations of Texas (CIT) | Plano | Texas | 75075 | United States |
| Sun Research Institute (SRI) - San Antonio | San Antonio | Texas | 78215 | United States |
| San Antonio Clinical Trials | San Antonio | Texas | 78240 | United States |
| Sugar Lakes Family Practice (Elligo Health Research) | Sugar Land | Texas | 77479 | United States |
| The University of Utah | Salt Lake City | Utah | 84108 | United States |
| Burke Internal Medicine | Burke | Virginia | 22015 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23510 | United States |
| Centricity Research (IACT Health) (Hampton Roads Center For Clinical Research, Inc.)) - Suffolk Multispecialty Research | Suffolk | Virginia | 23435 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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