A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

May 19, 2021

Primary Completion Date

January 4, 2024

Study Completion Date

July 2, 2024

Conditions
Pulmonary Arterial HypertensionHypertension, Pulmonary
Interventions
DRUG

Frespaciguat

Frespaciguat (soluble guanylate cyclase stimulator) 380 µg, 100 µg or 32 µg administered as dry powder inhalation

DRUG

Placebo to Frespaciguat

Placebo administered as dry powder inhalation

Trial Locations (91)

1039

Sanatorio de la Trinidad Mitre ( Site 0130), Buenos Aires

1051

Greenlane Clinical Centre ( Site 0203), Auckland

1070

Université Libre de Bruxelles - Hôpital Erasme ( Site 0601), Brussels

1888

Hospital El Cruce Nestor Carlos Kirchner ( Site 0132), San Juan Bautista

2109

Macquarie University ( Site 0180), Macquarie University

2305

John Hunter Hospital ( Site 0185), Newcastle

2747

Nepean Hospital ( Site 0184), Kingswood

3000

UZ Leuven ( Site 0600), Leuven

8011

Christchurch Hospital ( Site 0201), Christchurch

14080

Instituto Nacional de Cardiología -Ignacio Chavez ( Site 0651), Mexico City

20007

Georgetown University Hospital ( Site 0025), Washington D.C.

20138

Centro Cardiologico Monzino IRCCS ( Site 0306), Milan

20900

Ospedale San Gerardo - ASST Monza ( Site 0304), Monza

21201

University of Maryland ( Site 0032), Baltimore

23507

Sentara Norfolk General Hospital ( Site 0014), Norfolk

26040

Eskisehir Osmangazi Uni. Tip Fakultesi Hastanesi ( Site 0506), Eskişehir

26506

West Virginia University-WVU Heart and Vascular Institute ( Site 0051), Morgantown

27100

Fondazione IRCCS Policlinico San Matteo ( Site 0302), Pavia

27514

Clinical Trials Unit at Eastowne Medical Office Building ( Site 0019), Chapel Hill

29609

CHRU Brest - Hopital Cavale Blanche ( Site 0254), Brest

29621

AnMed Health ( Site 0033), Anderson

30625

Medizinische Hochschule Hannover ( Site 0284), Hanover

31059

CHU de Toulouse - Hopital Larrey ( Site 0258), Toulouse

32803

AdventHealth Orlando ( Site 0040), Orlando

33136

University of Miami Hospital-Division of Pulmonary & Critical Care ( Site 0053), Miami

33606

Tampa General Hospital ( Site 0058), Tampa

34096

Istanbul Uni. Kardiyoloji Enstitusu ( Site 0502), Istanbul

34390

Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0509), Istanbul

34899

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0501), Istanbul

35100

Ege Universitesi Hastanesi-Cardilogy Department ( Site 0504), Bornova

35330

Dokuz Eylul University Faculty of Medicine ( Site 0505), Izmir

35392

UKGM Gießen/Marburg ( Site 0279), Giessen

37934

Statcare Pulmonary Consultants ( Site 0067), Knoxville

40202

Norton Pulmonary Specialists ( Site 0048), Louisville

40536

University of Kentucky ( Site 0006), Lexington

52242

University of Iowa Hospital and Clinics ( Site 0009), Iowa City

52763

Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas ( Site 0653), Huixquilucan

54636

AHEPA University General Hospital of Thessaloniki ( Site 0577), Thessaloniki

59037

Institut Coeur Poumon - CHRU de Lille ( Site 0252), Lille

63110

Washington University School of Medicine ( Site 0066), St Louis

66160

University of Kansas Medical Center ( Site 0038), Kansas City

68198

University of Nebraska Medical Center ( Site 0041), Omaha

69126

Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0276), Heidelberg

75390

University of Texas Southwestern Medical Center at Dallas ( Site 0012), Dallas

76031

Centre Hospitalier Universitaire de Rouen ( Site 0253), Rouen

77030

Houston Methodist Research Institute ( Site 0036), Houston

The University of Texas Health Science Center at Houston ( Site 0054), Houston

80045

University of Colorado - Denver ( Site 0003), Aurora

80100

University of Naples Federico II ( Site 0308), Naples

80631

Cardiovascular Institute of North Colorado - Banner Health ( Site 0013), Greeley

87131

University of New Mexico, Health Sciences Center ( Site 0028), Albuquerque

91193

Consultorio 1020 Hospital Angeles Xalapa ( Site 0654), Xalapa

94143

UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0063), San Francisco

94275

CHU - Hopital de Bicetre ( Site 0251), Le Kremlin-Bicêtre

95817

University of California Davis Health-Internal Medicine: Pulmonary, Critical Care and Sleep Medicine, Sacramento

97074

Klinikum Würzburg Mitte-Medizinische Klinik - Schwerpunkt Pneumologie & Beatmungsmedizin ( Site 0280, Würzburg

110231

Hospital Universitario San Ignacio ( Site 0152), Bogotá

197341

Almazov National Medical Research Centre of the Ministry of Health ( Site 0402), Saint Petersburg

650002

Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 0403), Kemerovo

681017

Fundacion Cardiovascular de Colombia ( Site 0155), Piedecuesta

3109601

Rambam Medical Center ( Site 0335), Haifa

4941492

Rabin Medical Center ( Site 0327), Petah Tikva

5810000

Wolfson Medical Center [Holon, Israel] ( Site 0333), Holon

8410101

Soroka Medical Center ( Site 0330), Beersheba

9103102

Shaare Zedek Medical Center ( Site 0331), Jerusalem

92037-7381

University of California San Diego Health-Pulmonary Critical Care ( Site 0061), La Jolla

46202-1239

Indiana University Health Methodist Hospital ( Site 0045), Indianapolis

C1425BNG

Cardiologia Palermo ( Site 0140), Ciudad Autonoma de Buenos Aires

B1904AAW

Centro Medico Capital ( Site 0131), La Plata

B1629ODT

Hospital Universitario Austral ( Site 0138), Pilar

B1878GEG

Instituto de Investigaciones Clinicas Quilmes ( Site 0141), Quilmes

S2000DSR

Instituto Cardiovascular de Rosario ( Site 0128), Rosario

X5016KEH

Hospital Privado Universitario de Córdoba ( Site 0137), Córdoba

T1Y 6J4

Peter Lougheed Centre ( Site 0107), Calgary

M5G 2N2

University Health Network - Toronto General Hospital ( Site 0104), Toronto

G1V 4G5

IUCPQ ( Site 0111), Québec

050034

Centro Cardiovascular Colombiano Clínica Santa María ( Site 0154), Medellín

01307

Uniklinikum Dresden ( Site 0283), Dresden

04103

Universitaetsklinikum Leipzig ( Site 0285), Leipzig

00161

Azienda Ospedaliera Policlinico Umberto I ( Site 0301), Rome

31-202

Krakowski Szpital Specjalistyczny im. Jana Pawa II-Oddzial Kliniczny Chorob Serca i Naczyn z Pododd, Krakow

58-309

Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0351), Wałbrzych

20-954

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie ( Site 0352), Lublin

751 85

Akademiska sjukhuset ( Site 0453), Uppsala

413 45

Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0452), Gothenburg

06100

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0510), Ankara

07059

Akdeniz Uni.Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi ( Site 0508), Antalya

G81 4DY

Golden Jubilee National Hospital ( Site 0556), Glasgow

SW3 6NP

Royal Brompton and Harefield NHS Trust ( Site 0553), London

W12 0HS

Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0554), London

NE7 7DN

The Freeman Hosp.Newcastle upon Tyne Hosp NHS Trust ( Site 0552), Newcastle upon Tyne

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY