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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo once daily (QD) for 12 weeks |
|
| Dose 1 | Experimental | 50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks |
|
| Dose 2 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo once daily (QD) for 12 weeks |
| |
| lorundrostat Dose 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in automated office BP (AOBP) SBP at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with AOBP SBP <130 mmHg at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo | Week 6 | |
| Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat 50 mg QD with escalation to lorundrostat 100 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 |
|---|---|---|---|---|---|---|
| Advanced Cardiovascular, LLC - Alexander City Office | Alexander City | Alabama | 35010 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40587141 | Derived | Saxena M, Laffin L, Borghi C, Fernandez Fernandez B, Ghali JK, Kopjar B, Polu K, Roger SD, Slingsby BT, Strutz F, Vogt L, Weir MR, Rodman D; Launch-HTN Investigators. Lorundrostat in Participants With Uncontrolled Hypertension and Treatment-Resistant Hypertension: The Launch-HTN Randomized Clinical Trial. JAMA. 2025 Aug 5;334(5):409-418. doi: 10.1001/jama.2025.9413. |
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| Drug |
50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks |
|
| lorundrostat Dose 2 | Drug | 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 |
|
| Week 12 |
| Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications | Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to placebo | Week 6 |
| Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications | Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to placebo | Week 6 |
| Change from baseline in AOBP SBP at Week 6 by obesity status in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo | Week 6 |
| Change from baseline in AOBP SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at week 6 (within-subjects analysis) | Week 12 |
| Central Research Associates, Inc |
| Birmingham |
| Alabama |
| 35205 |
| United States |
| Cardiology, P.C. | Birmingham | Alabama | 35211-1309 | United States |
| Synexus (Radiant Research, Inc) - Alabama - Simon Williamson Clinic Location | Birmingham | Alabama | 35211 | United States |
| G & L Research LLC - Foley | Foley | Alabama | 36535 | United States |
| Accel Research Sites (ARS) - Birmingham Clinical Research Unit | Vestavia Hills | Alabama | 35216 | United States |
| Del Sol Research | Tucson | Arizona | 85715 | United States |
| Entertainment Medical Group, Inc. | Beverly Hills | California | 90211 | United States |
| Amicis Research Center - Granada Hills | Granada Hills | California | 91344 | United States |
| Amicis Research Center - Northridge | Granada Hills | California | 91344 | United States |
| Marvel Clinical Research, LLC | Huntington Beach | California | 92647 | United States |
| Amicis Research Center | Northridge | California | 91324 | United States |
| Pasadena Clinical Trials | Pasadena | California | 91101 | United States |
| Empire Clinical Research (ECR) | Pomona | California | 91767 | United States |
| Clinical Trials Research (CTR) - Sacramento | Sacramento | California | 95821 | United States |
| North America Research Institute | San Dimas | California | 91773 | United States |
| Amicis Research Center - Valencia | Valencia | California | 91355 | United States |
| CMR of Greater New Haven | Hamden | Connecticut | 06517 | United States |
| Chase Medical Research, LLC - Hamden | Waterbury | Connecticut | 06708-3346 | United States |
| Indago Research and Health Center | Hialeah | Florida | 33012 | United States |
| Clinical Neuroscience Solutions (CNS Healthcare) - Jacksonville | Jacksonville | Florida | 32256 | United States |
| Nuovida Research Center Corp | Miami | Florida | 33175 | United States |
| Clinical Neuroscience Solutions (CNS Healthcare) - Orlando Research Center | Orlando | Florida | 32801 | United States |
| AES Orlando | Orlando | Florida | 32806 | United States |
| Patron Medical - Andres Patron D.O. (Patron Ventures, LLC) | Pembroke Pines | Florida | 33026 | United States |
| Pines Care Research Center, LLC | Pembroke Pines | Florida | 33026 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Clinical Research of West Florida (CRWF) - Clearwater | Tampa | Florida | 33606 | United States |
| AES The Villages | The Villages | Florida | 32162 | United States |
| Morehouse School of Medicine (MSM) | Atlanta | Georgia | 30310-1458 | United States |
| ClinCept, LLC | Columbus | Georgia | 31904 | United States |
| Accel Research Sites- Decatur | Decatur | Georgia | 30030 | United States |
| Georgia Clinical Research Center, Inc | Lawrenceville | Georgia | 30044 | United States |
| Elite Clinical Trials | Blackfoot | Idaho | 83221 | United States |
| Rocky Mountain Diabetes Center | Idaho Falls | Idaho | 83404-7596 | United States |
| Solaris Clinical Research (SCR) | Meridian | Idaho | 83616 | United States |
| Synexus (Radiant Research, Inc) - Chicago | Chicago | Illinois | 60602 | United States |
| Healthcare Research Network-Chicago, Illinois (Flossmoor) Location | Flossmoor | Illinois | 60422 | United States |
| Koch Family Medicine, S.C. | Morton | Illinois | 61550 | United States |
| Southern Illinois University School of Medicine - SIU Clinics - SIU Internal Medicine | Springfield | Illinois | 62702 | United States |
| Investigators Research Group LLC | Brownsburg | Indiana | 46112 | United States |
| Franciscan Physician Network | Indianapolis | Indiana | 46237-6345 | United States |
| ASHA Clinical Research- Munster, LLC | Munster | Indiana | 46321 | United States |
| Synexus (Radiant Research, Inc) - Evansville | Newburgh | Indiana | 47630 | United States |
| Louisville Metabolic and Atherosclerosis Research Center (L-MARC) | Louisville | Kentucky | 40213 | United States |
| Tulane Doctors - Heart & Vascular - Metairie | New Orleans | Louisiana | 70112-2600 | United States |
| The Alliance for Multispecialty Research LLC (AMR) - Louisiana | New Orleans | Louisiana | 70119 | United States |
| Northwest Louisiana Nephrology, LLC - Shreveport | Shreveport | Louisiana | 71101 | United States |
| Grace Research, LLC | Shreveport | Louisiana | 71115 | United States |
| Boston Clinical Trials (BCT) | Boston | Massachusetts | 02131 | United States |
| ActivMed Practices and Research | Methuen | Massachusetts | 01844 | United States |
| Hattiesburg Clinic - Medisync Clinical Research | Petal | Mississippi | 39465 | United States |
| Healthcare Research Network-Hazelwood | Hazelwood | Missouri | 63042 | United States |
| Clinical Research Consultants (CRC) - Kansas City | Kansas City | Missouri | 64111 | United States |
| Quality Clinical Research Inc. (QCR) - Omaha | Omaha | Nebraska | 68114 | United States |
| Synexus (Radiant Research, Inc) - Nevada - Rita B. Chuang, MD | Henderson | Nevada | 89052 | United States |
| Sierra Clinical Research-Las Vegas | Las Vegas | Nevada | 89106 | United States |
| Renown Regional Medical Center (Washoe Medical Center) | Reno | Nevada | 89502 | United States |
| Synexus (Radiant Research, Inc) - New York | Jamaica | New York | 11432 | United States |
| North Shore Diabetes and Endocrine Associates (NSDEA) - New Hyde Park | New Hyde Park | New York | 11042-1214 | United States |
| Columbia University | New York | New York | 10032-3725 | United States |
| Randolph Health Internal Medicine/ Triad Internal Medicine | Asheboro | North Carolina | 272205 | United States |
| East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location | Greenville | North Carolina | 27834 | United States |
| Physicians East, P.A. - Endocrinology | Greenville | North Carolina | 27834 | United States |
| Carteret Medical Group - Morehead City | Morehead City | North Carolina | 28557 | United States |
| Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC) (DEC) | New Bern | North Carolina | 28562 | United States |
| Diabetes & Endocrinology Associates of Stark County | Canton | Ohio | 44718 | United States |
| Lynn Institute of Norman (LION Research) | Norman | Oklahoma | 73072 | United States |
| Valley Kidney Specialists PC - Allentown Cedar Crest | Bethlehem | Pennsylvania | 18017 | United States |
| Preferred Primary Care Physicians - Pleasant Hills - Curry Hollow Rd Location | Pittsburgh | Pennsylvania | 15236 | United States |
| Preferred Primary Care Physicians (PPCP) - Uniontown - Jacob Murphy Lane Location | Uniontown | Pennsylvania | 15401 | United States |
| Chattanooga Medical Research (CMR), LLC | Chattanooga | Tennessee | 37403 | United States |
| The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group) | Knoxville | Tennessee | 37920 | United States |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | 38119 | United States |
| Punzi Medical Center and Trinity Hypertension Research Institute | Carrollton | Texas | 75006 | United States |
| AES Dallas Fort Worth | Dallas | Texas | 75234 | United States |
| Synergy Groups Medical | Houston | Texas | 77036 | United States |
| Juno Research, LLC | Houston | Texas | 77054 | United States |
| Discovery Clinical Trials (DCT) - McAllen | McAllen | Texas | 78503 | United States |
| Synergy Groups Medical - Missouri City | Missouri City | Texas | 35010 | United States |
| North Texas Family Medicine (NTFM) - Plano Office | Plano | Texas | 75093 | United States |
| Sun Research Institute (SRI) - San Antonio | San Antonio | Texas | 78215 | United States |
| Discovery Clinical Trials (DCT) - San Antonio | San Antonio | Texas | 78258 | United States |
| Global AES - Salt Lake City | Salt Lake City | Utah | 84106 | United States |
| Velocity Clinical Research - Salt Lake City (Advanced Clinical Research) | West Jordan | Utah | 84088 | United States |
| Burke Internal Medicine | Burke | Virginia | 22015 | United States |
| Eastern VA Medical School | Norfolk | Virginia | 23501 | United States |
| Castle Hill Medical Centre | Castle Hill | New South Wales | 2154 | Australia |
| Renal Research - Gosford | Gosford | New South Wales | 2250 | Australia |
| University of Newcastle - John Hunter Hospital (JHH) | Waratah | New South Wales | 2298 | Australia |
| University of the Sunshine Coast - Clinical Trials Centre | Sippy Downs | Queensland | 4556 | Australia |
| South Coast Renal | Southport | Queensland | 4215 | Australia |
| AusTrials - Taringa | Taringa | Queensland | 4068 | Australia |
| AusTrials - Wellers Hill | Taringa | Queensland | 4068 | Australia |
| Fusion Clinical Research | Adelaide | South Australia | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Dobney Hypertension Centre/ Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Austin Health - Heidelberg Repatriation Hospital | Heidelberg Heights | 3081 | Australia |
| AusTrials - Sunshine | St Albans | VIC 3021 | Australia |
| Medical Center New Polyclinic Gabrovo Ltd. | Gabrovo | 5300 | Bulgaria |
| Medical center Exacta Medica | Pleven | 5800 | Bulgaria |
| Medical Center Hera EOOD - Sofia | Sofia | 1510 | Bulgaria |
| ASOMHIDC (Ambulatory of specialized outpatient medical help in internal diseases and cardiology) | Sofia | 1592 | Bulgaria |
| Medical Centre Zara-Med | Stara Zagora | 6000 | Bulgaria |
| DCC 1 - Veliko Tarnovo | Veliko Tarnovo | 5000 | Bulgaria |
| University of Alberta | Edmonton | Alberta | T6G 2G3 | Canada |
| Stephen S. Chow Medicine Professional Corporation | East York | Ontario | M4C 5T2 | Canada |
| Centre Medical L'Acadie - Montreal | Montreal | Quebec | H4N 2W2 | Canada |
| Centre Hospitalier Annecy Genevois (CHANGE) - Site d'Annecy - | Annecy | 74011 | France |
| Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre | Bordeaux | 33000 | France |
| Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau | Nîmes | 30029 | France |
| Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC) | Strasbourg | 67091 | France |
| kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Hannover-Mitte GmbH (KFHM) | Hanover | Lower Saxony | 30159 | Germany |
| Pfuetzner Science & Health Institute GmbH (PSHI) - Diabeteszentrum & Praxis | Mainz | Rhineland-Palatinate | 55116 | Germany |
| kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Dresden GmbH (KFDD) | Dresden | Saxony | 01069 | Germany |
| Herzzentrum Leipzig | Leipzig | Saxony | 04289 | Germany |
| Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF) | Berlin | 10117 | Germany |
| emovis GmbH | Berlin | 10629 | Germany |
| Gemeinscharftspraxis Dres Jung - Deggingen | Deggingen | 73326 | Germany |
| kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Karlsruhe GmbH (KFKA) | Karlsruhe | Germany |
| Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie | Leipzig | 04103 | Germany |
| KfH Kuratorium fuer Dialyse und Nierentransplantation e.V. - KfH-Nierenzentrum Klaus-Ketzler-Zentrum | Wiesbaden | 65191 | Germany |
| Gruppo Humanitas - Humanitas Research Hospital (Istituto Clinico Humanitas) | Rozzano | Milan | 20089 | Italy |
| Azienda Ospedaliero-Universitaria Sant'Andrea Roma, Centro Ipertensione, UOC di Cardiologia | Roma | Rome | 00189 | Italy |
| Istituto Nazionale di Riposo e Cura per Anziani (INRCA) | Ancona | 60127 | Italy |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | 40138 | Italy |
| Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia | Brescia | 251123 | Italy |
| Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna | Ferrara | 44124 | Italy |
| IRCCS Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| Azienda Sanitaria Locale 1 (ASL 1) - Ospedale Regionale San Salvatore | L’Aquila | 67100 | Italy |
| Universita degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino" - Messina | Messina | 98125 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| AOU Policlinico di Modena - UO Cardiologia | Modena | 41121 | Italy |
| Azienda Ospedaliera Universitaria (AOU) di Napoli | Naples | 80131 | Italy |
| Fondazione IRCCS Policlinico San Matteo, - SC Ematologia, Dipartimento Oncoematologico | Pavia | 27100 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| IRCCS San Raffaele | Rome | 00163 | Italy |
| Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc) | Nijmegen | Gelderland | 6525 GA | Netherlands |
| Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum) | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Albert Schweitzer Ziekenhuis - Sliedrecht | Dordrecht | South Holland | Netherlands |
| Universitair Medisch Centrum (UMC) Utrecht - Locatie AZU | Utrecht | 3508 GA | Netherlands |
| Diamond Clinic Specjalistyczne Poradnie Lekarskie | Krakow | Lesser Poland Voivodeship | 31-559 | Poland |
| Velocity Lublin | Lubin | Polska | 20-362 | Poland |
| Velocity Skierniewice Sp. z o.o | Skierniewice | Polska | 96-100 | Poland |
| ETG Network - Warszawa (European Trial Group) | Warsaw | Polska | 02-677 | Poland |
| Etyka OÅ>rodek BadaÅ" Klinicznych | Olsztyn | Warmian-Masurian Voivodeship | 10-117 | Poland |
| Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach | Katowice | 40-027 | Poland |
| Silmedic Sp. z o.o | Katowice | 40-282 | Poland |
| FutureMeds Sp. z o.o. FutureMeds Lodz | Lodz | Poland |
| FutureMeds Sp. z o.o. Futuremeds Olsztyn | Olsztyn | 10-010 | Poland |
| Latin Clinical Trial Center Inc. (LCTC) | San Juan | 00936 | Puerto Rico |
| Spitalul Clinic Judetean de Urgenta Tg. Mures | Târgu Mureş | Mureș County | 540136 | Romania |
| Centrul Medicali's Timisoara | Timișoara | Timiș County | 300362 | Romania |
| Centrul Medical Unirea SRL Brasov (Regina Maria) | Brasov | 500091 | Romania |
| Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria) | Bucharest | 014146 | Romania |
| Spitalul Clinic Colentina | Bucharest | 020125 | Romania |
| Angiocare S.R.L. (Spitalul Ares Cluj-Napoca) | Cluj-Napoca | 400015 | Romania |
| Spitalul Clinic Municipal Filantropia Craiova | Craiova | 200508 | Romania |
| Spitalul Clinic Judetean de Urgenta Bihor | Oradea | 410169 | Romania |
| S.C Materna Care SRL Timisoara (Regina Maria) | Timișoara | 300644 | Romania |
| Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara | Timișoara | 300723 | Romania |
| Complejo Hospitalario Universitario de Badajoz (CHUB) (Hospital Infanta Cristina) | Badajoz | 6080 | Spain |
| Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM) | Barcelona | 8003 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de las Nieves (HUVN) | Granada | 18014 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) - Instituto de Investigacion Sanitaria (IIS) | Madrid | 28040 | Spain |
| Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital) | Santiago de Compostela | 15706 | Spain |
| Instituto de Investigacion Sanitaria (INCLIVA) | Valencia | 46010 | Spain |
| Fowey River Practice - Fowey Surgery | Fowey | Great Britain | PL23 1DT | United Kingdom |
| Queen Mary University of London (QMUL) - Barts and The London School of Medicine and Dentistry - William Harvey Research Institute (WHRI) - William Harvey Heart Centre (WHHC) | London | Great Britain | EC1M 6BQ | United Kingdom |
| Knowle House Surgery | Plymouth | Great Britain | PL5 3JB | United Kingdom |
| The Rame Group Practice (Dr. DAVIS & Partners) - Penntorr Health | Torpoint | Great Britain | PL11 2TB | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH) | Canterbury | Kent | CT1 3NG | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | AB25 2ZN | United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust - Birmingham Regional Severe Asthma Service (BRSAS) | Birmingham | B9 5SS | United Kingdom |
| East Kent Hospitals University NHS Foundation Trust | Canterbury | CT1 3NG | United Kingdom |
| Epsom and St Helier University Hospitals NHS Trust | Carshalton | SM5 1AA | United Kingdom |
| Rowden Surgery Rowden Medical Partnership | Chippenham | SN15 2SB | United Kingdom |
| NHS Greater Glasgow and Clyde (NHSGGC) | Glasgow | G12 8TA | United Kingdom |
| Newquay Health Centre | Newquay | TR7 1RU | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital | Sheffield | S5 7AU | United Kingdom |
| FutureMeds - Stockton-on-Tees | Stockton-on-Tees | TS19 8PE | United Kingdom |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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