Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

1,083

Participants

Timeline

Start Date

November 22, 2023

Primary Completion Date

December 10, 2024

Study Completion Date

January 24, 2025

Conditions
Hypertension
Interventions
DRUG

Placebo

Placebo once daily (QD) for 12 weeks

DRUG

lorundrostat Dose 1

50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks

DRUG

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

Trial Locations (184)

1510

Medical Center Hera EOOD - Sofia, Sofia

1592

ASOMHIDC (Ambulatory of specialized outpatient medical help in internal diseases and cardiology), Sofia

2154

Castle Hill Medical Centre, Castle Hill

2250

Renal Research - Gosford, Gosford

2298

University of Newcastle - John Hunter Hospital (JHH), Waratah

3081

Austin Health - Heidelberg Repatriation Hospital, Heidelberg Heights

4068

AusTrials - Taringa, Taringa

AusTrials - Wellers Hill, Taringa

4215

South Coast Renal, Southport

4556

University of the Sunshine Coast - Clinical Trials Centre, Sippy Downs

5000

DCC 1 - Veliko Tarnovo, Veliko Tarnovo

5300

Medical Center New Polyclinic Gabrovo Ltd., Gabrovo

5800

Medical center Exacta Medica, Pleven

6000

Dobney Hypertension Centre/ Royal Perth Hospital, Perth

Medical Centre Zara-Med, Stara Zagora

6080

Complejo Hospitalario Universitario de Badajoz (CHUB) (Hospital Infanta Cristina), Badajoz

7000

Royal Hobart Hospital, Hobart

8003

Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM), Barcelona

10117

Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF), Berlin

10629

emovis GmbH, Berlin

11432

Synexus (Radiant Research, Inc) - New York, Jamaica

14004

Hospital Universitario Reina Sofia, Córdoba

15236

Preferred Primary Care Physicians - Pleasant Hills - Curry Hollow Rd Location, Pittsburgh

15401

Preferred Primary Care Physicians (PPCP) - Uniontown - Jacob Murphy Lane Location, Uniontown

15706

Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital), Santiago de Compostela

16132

IRCCS Ospedale Policlinico San Martino, Genova

18014

Hospital Universitario Virgen de las Nieves (HUVN), Granada

18017

Valley Kidney Specialists PC - Allentown Cedar Crest, Bethlehem

20089

Gruppo Humanitas - Humanitas Research Hospital (Istituto Clinico Humanitas), Rozzano

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

22015

Burke Internal Medicine, Burke

23501

Eastern VA Medical School, Norfolk

27100

Fondazione IRCCS Policlinico San Matteo, - SC Ematologia, Dipartimento Oncoematologico, Pavia

27834

East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location, Greenville

Physicians East, P.A. - Endocrinology, Greenville

28040

Hospital Clínico San Carlos, Madrid

Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) - Instituto de Investigacion Sanitaria (IIS), Madrid

28557

Carteret Medical Group - Morehead City, Morehead City

28562

Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC) (DEC), New Bern

30029

Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau, Nîmes

30030

Accel Research Sites- Decatur, Decatur

30044

Georgia Clinical Research Center, Inc, Lawrenceville

30159

kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Hannover-Mitte GmbH (KFHM), Hanover

31904

ClinCept, LLC, Columbus

32127

Progressive Medical Research, Port Orange

32162

AES The Villages, The Villages

32256

Clinical Neuroscience Solutions (CNS Healthcare) - Jacksonville, Jacksonville

32801

Clinical Neuroscience Solutions (CNS Healthcare) - Orlando Research Center, Orlando

32806

AES Orlando, Orlando

33000

Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre, Bordeaux

33012

Indago Research and Health Center, Hialeah

33026

Patron Medical - Andres Patron D.O. (Patron Ventures, LLC), Pembroke Pines

Pines Care Research Center, LLC, Pembroke Pines

33175

Nuovida Research Center Corp, Miami

33606

Clinical Research of West Florida (CRWF) - Clearwater, Tampa

35010

Advanced Cardiovascular, LLC - Alexander City Office, Alexander City

Synergy Groups Medical - Missouri City, Missouri City

35205

Central Research Associates, Inc, Birmingham

35211

Synexus (Radiant Research, Inc) - Alabama - Simon Williamson Clinic Location, Birmingham

35216

Accel Research Sites (ARS) - Birmingham Clinical Research Unit, Vestavia Hills

36535

G & L Research LLC - Foley, Foley

37403

Chattanooga Medical Research (CMR), LLC, Chattanooga

37920

The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group), Knoxville

38119

Clinical Neuroscience Solutions, Inc, Memphis

39465

Hattiesburg Clinic - Medisync Clinical Research, Petal

40138

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna

40213

Louisville Metabolic and Atherosclerosis Research Center (L-MARC), Louisville

41121

AOU Policlinico di Modena - UO Cardiologia, Modena

42270

Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord, Saint-Priest-en-Jarez

44124

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna, Ferrara

44718

Diabetes & Endocrinology Associates of Stark County, Canton

46010

Instituto de Investigacion Sanitaria (INCLIVA), Valencia

46112

Investigators Research Group LLC, Brownsburg

46321

ASHA Clinical Research- Munster, LLC, Munster

47630

Synexus (Radiant Research, Inc) - Evansville, Newburgh

55116

Pfuetzner Science & Health Institute GmbH (PSHI) - Diabeteszentrum & Praxis, Mainz

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

60127

Istituto Nazionale di Riposo e Cura per Anziani (INRCA), Ancona

60422

Healthcare Research Network-Chicago, Illinois (Flossmoor) Location, Flossmoor

60602

Synexus (Radiant Research, Inc) - Chicago, Chicago

61550

Koch Family Medicine, S.C., Morton

62702

Southern Illinois University School of Medicine - SIU Clinics - SIU Internal Medicine, Springfield

63042

Healthcare Research Network-Hazelwood, Hazelwood

64111

Clinical Research Consultants (CRC) - Kansas City, Kansas City

65191

KfH Kuratorium fuer Dialyse und Nierentransplantation e.V. - KfH-Nierenzentrum Klaus-Ketzler-Zentrum, Wiesbaden

67091

Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC), Strasbourg

67100

Azienda Sanitaria Locale 1 (ASL 1) - Ospedale Regionale San Salvatore, L’Aquila

68114

Quality Clinical Research Inc. (QCR) - Omaha, Omaha

70119

The Alliance for Multispecialty Research LLC (AMR) - Louisiana, New Orleans

71101

Northwest Louisiana Nephrology, LLC - Shreveport, Shreveport

71115

Grace Research, LLC, Shreveport

73072

Lynn Institute of Norman (LION Research), Norman

73326

Gemeinscharftspraxis Dres Jung - Deggingen, Deggingen

74011

Centre Hospitalier Annecy Genevois (CHANGE) - Site d'Annecy -, Annecy

75006

Punzi Medical Center and Trinity Hypertension Research Institute, Carrollton

75093

North Texas Family Medicine (NTFM) - Plano Office, Plano

75234

AES Dallas Fort Worth, Dallas

77036

Synergy Groups Medical, Houston

77054

Juno Research, LLC, Houston

78215

Sun Research Institute (SRI) - San Antonio, San Antonio

78258

Discovery Clinical Trials (DCT) - San Antonio, San Antonio

78503

Discovery Clinical Trials (DCT) - McAllen, McAllen

80131

Azienda Ospedaliera Universitaria (AOU) di Napoli, Napoli

83221

Elite Clinical Trials, Blackfoot

83616

Solaris Clinical Research (SCR), Meridian

84088

Velocity Clinical Research - Salt Lake City (Advanced Clinical Research), West Jordan

84106

Global AES - Salt Lake City, Salt Lake City

85715

Del Sol Research, Tucson

89052

Synexus (Radiant Research, Inc) - Nevada - Rita B. Chuang, MD, Henderson

89106

Sierra Clinical Research-Las Vegas, Las Vegas

89502

Renown Regional Medical Center (Washoe Medical Center), Reno

90211

Entertainment Medical Group, Inc., Beverly Hills

91101

Pasadena Clinical Trials, Pasadena

91324

Amicis Research Center, Northridge

91344

Amicis Research Center - Granada Hills, Granada Hills

Amicis Research Center - Northridge, Granada Hills

91355

Amicis Research Center - Valencia, Valencia

91767

Empire Clinical Research (ECR), Pomona

91773

North America Research Institute, San Dimas

92647

Marvel Clinical Research, LLC, Huntington Beach

95821

Clinical Trials Research (CTR) - Sacramento, Sacramento

98125

"Universita degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico Gaetano Martino - Messina", Messina

200508

Spitalul Clinic Municipal Filantropia Craiova, Craiova

251123

Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia, Brescia

272205

Randolph Health Internal Medicine/ Triad Internal Medicine, Asheboro

300362

Centrul Medicali's Timisoara, Timișoara

300644

S.C Materna Care SRL Timisoara (Regina Maria), Timișoara

300723

"Spitalul Clinic Judetean de Urgenta Pius Branzeu Timisoara", Timișoara

400015

Angiocare S.R.L. (Spitalul Ares Cluj-Napoca), Cluj-Napoca

410169

Spitalul Clinic Judetean de Urgenta Bihor, Oradea

500091

Centrul Medical Unirea SRL Brasov (Regina Maria), Brasov

540136

Spitalul Clinic Judetean de Urgenta Tg. Mures, Târgu Mureş

35211-1309

Cardiology, P.C., Birmingham

06517

CMR of Greater New Haven, Hamden

06708-3346

Chase Medical Research, LLC - Hamden, Waterbury

30310-1458

Morehouse School of Medicine (MSM), Atlanta

83404-7596

Rocky Mountain Diabetes Center, Idaho Falls

46237-6345

Franciscan Physician Network, Indianapolis

70112-2600

Tulane Doctors - Heart & Vascular - Metairie, New Orleans

02131

Boston Clinical Trials (BCT), Boston

01844

ActivMed Practices and Research, Methuen

11042-1214

North Shore Diabetes and Endocrine Associates (NSDEA) - New Hyde Park, New Hyde Park

10032-3725

Columbia University, New York

Unknown

Fusion Clinical Research, Adelaide

kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Karlsruhe GmbH (KFKA), Karlsruhe

Albert Schweitzer Ziekenhuis - Sliedrecht, Dordrecht

FutureMeds Sp. z o.o. FutureMeds Lodz, Lodz

VIC 3021

AusTrials - Sunshine, St Albans

T6G 2G3

University of Alberta, Edmonton

M4C 5T2

Stephen S. Chow Medicine Professional Corporation, East York

H4N 2W2

Centre Medical L'Acadie - Montreal, Montreal

01069

kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Dresden GmbH (KFDD), Dresden

04289

Herzzentrum Leipzig, Leipzig

04103

Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie, Leipzig

00189

Azienda Ospedaliero-Universitaria Sant'Andrea Roma, Centro Ipertensione, UOC di Cardiologia, Roma

00163

IRCCS San Raffaele, Rome

6525 GA

Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc), Nijmegen

1105 AZ

Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum), Amsterdam

3508 GA

Universitair Medisch Centrum (UMC) Utrecht - Locatie AZU, Utrecht

31-559

Diamond Clinic Specjalistyczne Poradnie Lekarskie, Krakow

20-362

Velocity Lublin, Lubin

96-100

Velocity Skierniewice Sp. z o.o, Skierniewice

02-677

ETG Network - Warszawa (European Trial Group), Warsaw

10-117

"Etyka OÅ>rodek BadaÅ Klinicznych", Olsztyn

40-027

Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice

40-282

Silmedic Sp. z o.o, Katowice

10-010

FutureMeds Sp. z o.o. Futuremeds Olsztyn, Olsztyn

00936

Latin Clinical Trial Center Inc. (LCTC), San Juan

014146

Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria), Bucharest

020125

Spitalul Clinic Colentina, Bucharest

PL23 1DT

Fowey River Practice - Fowey Surgery, Fowey

EC1M 6BQ

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

PL5 3JB

Knowle House Surgery, Plymouth

PL11 2TB

The Rame Group Practice (Dr. DAVIS & Partners) - Penntorr Health, Torpoint

CT1 3NG

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH), Canterbury

East Kent Hospitals University NHS Foundation Trust, Canterbury

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

B9 5SS

University Hospitals Birmingham NHS Foundation Trust - Birmingham Regional Severe Asthma Service (BRSAS), Birmingham

SM5 1AA

Epsom and St Helier University Hospitals NHS Trust, Carshalton

SN15 2SB

Rowden Surgery Rowden Medical Partnership, Chippenham

G12 8TA

NHS Greater Glasgow and Clyde (NHSGGC), Glasgow

TR7 1RU

Newquay Health Centre, Newquay

S5 7AU

Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital, Sheffield

TS19 8PE

FutureMeds - Stockton-on-Tees, Stockton-on-Tees

Sponsors
All Listed Sponsors
lead

Mineralys Therapeutics Inc.

INDUSTRY

NCT06153693 - Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension | Biotech Hunter | Biotech Hunter