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

Primary Purpose

Pulmonary Arterial Hypertension, Hypertension, Pulmonary

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MK-5475
Placebo to MK-5475
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pulmonary arterial hypertension (PAH) in one of the following groups:

    • Idiopathic PAH
    • Heritable PAH
    • Drug and toxin-induced PAH
    • PAH associated with connective tissue disease, HIV infection, or congenital heart disease.
  • Diagnosis of PAH documented by right heart catheterization (RHC).

  • Eligibility RHC meeting all of the following criteria:

    • Mean pulmonary artery pressure (mPAP) ≥25 mmHg
    • Pulmonary vascular resistance (PVR) of ≥3 Wood units
    • Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg.
  • World Health Organization functional class (WHO-FC) symptoms between Class II and IV.
  • Two 6-Minute walk distance (6MWD) measurements between 150 and 500 meters, one at screening and one at randomization.
  • Stable concomitant background PAH-specific therapy.
  • Body Mass Index (BMI) between 18.5 kg/m² and 40 kg/m² .
  • Agree to be abstinent from heterosexual intercourse or use contraception during the intervention period and for at least 14 days after the last dose of study intervention.
  • Female participants may not be pregnant or breastfeeding.

Exclusion Criteria:

  • Group 2 to 5 pulmonary hypertension.

  • PAH in one of the following groups:

    • Long term responders to calcium channel blockers
    • Overt features of venous/capillary involvement
  • Evidence of more-than-mild obstructive lung disease.
  • Evidence of more-than-mild parenchymal lung disease.
  • Evidence of more-than-mild obstructive sleep apnea (OSA) that is untreated.

  • Evidence or history of left heart disease, including any of the following:

    • Left ventricular ejection fraction (LVEF) ≤45%
    • Moderate or severe left-sided valvular disease (aortic or mitral valve stenosis or regurgitation)
    • Significant left ventricular diastolic dysfunction on echocardiographic evaluation
  • Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction: BMI>30 kg/m², essential systemic hypertension, diabetes mellitus of any type, or coronary artery disease.
  • Oxygen saturation measured by pulse oximetry (SpO₂) <90%, despite supplemental oxygen therapy.
  • Chronic renal insufficiency (eGFR <30 mL/min)
  • Chronic liver disease (i.e., Child-Pugh B or C), portal hypertension, cirrhosis, or significant hepatic laboratory abnormalities.
  • Current smoker or currently uses electronic cigarettes (vapes).
  • History of cancer, except: nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated, with appropriate follow up, and unlikely to recur for the duration of the study.

Sites / Locations

  • University of California San Diego Health-Pulmonary Critical Care ( Site 0061)Recruiting
  • University of California Davis Health-Internal Medicine: Pulmonary, Critical Care and Sleep MedicineRecruiting
  • UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0063)Recruiting
  • University of Colorado - Denver ( Site 0003)Recruiting
  • Cardiovascular Institute of North Colorado - Banner Health ( Site 0013)
  • Georgetown University Hospital ( Site 0025)
  • University of Miami Hospital-Division of Pulmonary & Critical Care ( Site 0053)Recruiting
  • AdventHealth Orlando ( Site 0040)Recruiting
  • Tampa General Hospital ( Site 0058)Recruiting
  • Indiana University Health Methodist Hospital ( Site 0045)Recruiting
  • University of Iowa Hospital and Clinics ( Site 0009)
  • University of Kansas Medical Center ( Site 0038)Recruiting
  • University of Kentucky ( Site 0006)Recruiting
  • Norton Pulmonary Specialists ( Site 0048)Recruiting
  • University of Maryland ( Site 0032)Recruiting
  • Washington University School of Medicine ( Site 0066)Recruiting
  • University of Nebraska Medical Center ( Site 0041)Recruiting
  • University of New Mexico, Health Sciences Center ( Site 0028)Recruiting
  • Clinical Trials Unit at Eastowne Medical Office Building ( Site 0019)Recruiting
  • AnMed Health ( Site 0033)
  • Statcare Pulmonary Consultants ( Site 0067)Recruiting
  • University of Texas Southwestern Medical Center at Dallas ( Site 0012)
  • Houston Methodist Research Institute ( Site 0036)Recruiting
  • The University of Texas Health Science Center at Houston ( Site 0054)Recruiting
  • Sentara Norfolk General Hospital ( Site 0014)
  • West Virginia University-WVU Heart and Vascular Institute ( Site 0051)Recruiting
  • Cardiologia Palermo ( Site 0140)Recruiting
  • Hospital El Cruce Nestor Carlos Kirchner ( Site 0132)Recruiting
  • Centro Medico Capital ( Site 0131)Recruiting
  • Hospital Universitario Austral ( Site 0138)Recruiting
  • Instituto de Investigaciones Clinicas Quilmes ( Site 0141)
  • Sanatorio de la Trinidad Mitre ( Site 0130)Recruiting
  • Instituto Cardiovascular de Rosario ( Site 0128)Recruiting
  • Hospital Privado Universitario de Córdoba ( Site 0137)Recruiting
  • Nepean Hospital ( Site 0184)Recruiting
  • Macquarie University ( Site 0180)Recruiting
  • John Hunter Hospital ( Site 0185)Recruiting
  • UZ Leuven ( Site 0600)Recruiting
  • Peter Lougheed Centre ( Site 0107)Recruiting
  • University Health Network - Toronto General Hospital ( Site 0104)Recruiting
  • IUCPQ ( Site 0111)Recruiting
  • Centro Cardiovascular Colombiano Clínica Santa María ( Site 0154)Recruiting
  • Hospital Universitario San Ignacio ( Site 0152)Recruiting
  • Fundacion Cardiovascular de Colombia ( Site 0155)Recruiting
  • CHRU Brest - Hopital Cavale Blanche ( Site 0254)Recruiting
  • CHU de Toulouse - Hopital Larrey ( Site 0258)Recruiting
  • Institut Coeur Poumon - CHRU de Lille ( Site 0252)Recruiting
  • Centre Hospitalier Universitaire de Rouen ( Site 0253)Recruiting
  • CHU - Hopital de Bicetre ( Site 0251)Recruiting
  • Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0276)Recruiting
  • Klinikum Würzburg Mitte-Medizinische Klinik - Schwerpunkt Pneumologie & Beatmungsmedizin ( Site 0280Recruiting
  • Universitaetsklinikum Giessen und Marburg GmbH ( Site 0279)Recruiting
  • Medizinische Hochschule Hannover ( Site 0284)Recruiting
  • Uniklinikum Dresden ( Site 0283)Recruiting
  • Universitaetsklinikum Leipzig ( Site 0285)Recruiting
  • AHEPA University General Hospital of Thessaloniki ( Site 0577)Recruiting
  • Soroka Medical Center ( Site 0330)Recruiting
  • Rambam Medical Center ( Site 0335)Recruiting
  • Wolfson Medical Center [Holon, Israel] ( Site 0333)
  • Shaare Zedek Medical Center ( Site 0331)Recruiting
  • Rabin Medical Center ( Site 0327)Recruiting
  • University of Naples Federico II ( Site 0308)Recruiting
  • Azienda Ospedaliera Policlinico Umberto I ( Site 0301)Recruiting
  • Ospedale San Gerardo - ASST Monza ( Site 0304)Recruiting
  • Centro Cardiologico Monzino IRCCS ( Site 0306)Recruiting
  • Fondazione IRCCS Policlinico San Matteo ( Site 0302)Recruiting
  • Consultorio 1020 Hospital Angeles Xalapa ( Site 0654)Recruiting
  • Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas ( Site 0653)Recruiting
  • Instituto Nacional de Cardiología -Ignacio Chavez ( Site 0651)Recruiting
  • Christchurch Hospital ( Site 0201)Recruiting
  • Greenlane Clinical Centre ( Site 0203)Recruiting
  • Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0351)Recruiting
  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie ( Site 0352)Recruiting
  • Krakowski Szpital Specjalistyczny im. Jana Pawa II-Oddzial Kliniczny Chorob Serca i Naczyn z PododdRecruiting
  • Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 0403)
  • Almazov National Medical Research Centre of the Ministry of Health ( Site 0402)
  • Akademiska sjukhuset ( Site 0453)Recruiting
  • Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0452)Recruiting
  • Ege Universitesi Hastanesi-Cardilogy Department ( Site 0504)Recruiting
  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0510)Recruiting
  • Akdeniz Uni.Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi ( Site 0508)Recruiting
  • Eskisehir Osmangazi Uni. Tip Fakultesi Hastanesi ( Site 0506)Recruiting
  • Istanbul Uni. Kardiyoloji Enstitusu ( Site 0502)Recruiting
  • Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0509)Recruiting
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0501)Recruiting
  • Dokuz Eylul University Faculty of Medicine ( Site 0505)Recruiting
  • Golden Jubilee National Hospital ( Site 0556)Recruiting
  • Royal Brompton and Harefield NHS Trust ( Site 0553)Recruiting
  • Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0554)Recruiting
  • The Freeman Hosp.Newcastle upon Tyne Hosp NHS Trust ( Site 0552)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Phase 2 Cohort MK-5475 380 µg

Phase 2 Cohort MK-5475 100 µg

Phase 2 Cohort MK-5475 32 µg

Phase 2 Cohort Placebo

Phase 3 Cohort MK-5475

Phase 3 Cohort Placebo

Arm Description

Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period and for optional 24 month extension period.

Participants receive MK-5475 100 µg via oral inhalation once daily for 12 week base period and for optional 24 month extension period.

Participants receive MK-5475 32 µg via oral inhalation once daily for 12 week base period and for optional 24 month extension period.

Participants receive placebo via oral inhalation once daily for 12 week base period, and one of the MK-5475 doses (380, 100, or 32 µg) for the optional 24 month extension period.

Participants receive one of 3 MK-5475 doses (380, 100 or 32 µg) to be selected at end of the Phase 2 Cohort, administered via oral inhalation once daily for 12-week base period and up to 60 months in the extension period

Participants receive placebo via oral inhalation once daily for 12 week base period and up to 60 months in the extension period.

Outcomes

Primary Outcome Measures

Phase 2 Cohort: Change from Baseline in Pulmonary Vascular Resistance (PVR) at 12 Weeks
PVR is assessed by right heart catheterization (RHC).
Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
6MWD is assessed using the 6-minute walk test (6MWT).

Secondary Outcome Measures

Phase 2 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
6MWD is assessed using the 6-minute walk test (6MWT).
Phase 2 Cohort: Change from Baseline in Mean Right Arterial Pressure (mRAP) at 12 Weeks
mRAP is assessed by right heart catheterization (RHC).
Phase 2 Cohort: Change from Baseline in Cardiac Index (CI) at 12 weeks
Cardiac index is assessed by right heart catheterization (RHC).
Phase 2 Cohort: Change from Baseline in Stroke Volume Index (SVI) at 12 weeks
SVI is assessed by right heart catheterization (RHC).
Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks
6MWD is assessed using the 6-minute walk test (6MWT).
Phase 3 Cohort: Change from Baseline in World Health Organization Functional Class (WHO-FC) at 12 Weeks
Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase.
Phase 2 Cohort: Number of Participants Who Experience an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Phase 2 Cohort: Number of Participants Who Discontinue Study Drug Due to an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Phase 3 Cohort: Number of Participants who Experience an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Phase 3 Cohort: Number of Participants who Discontinue Study Drug Due to an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Full Information

First Posted
January 27, 2021
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04732221
Brief Title
A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)
Official Title
A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
February 9, 2026 (Anticipated)
Study Completion Date
January 19, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a two-part (Phase 2/Phase 3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH). The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of MK-5475 during an optional 24 month extension period. The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part (Phase 3) of the study. The primary hypothesis of Phase 2 is that at least one MK-5475 dose is superior to placebo in reducing pulmonary vascular resistance (PVR) from baseline at week 12. The purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years. The primary hypothesis of Phase 3 is that MK-5475 is superior to placebo in increasing 6-minute walk distance (6MWD) from baseline at week 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Hypertension, Pulmonary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A total of approximately 450 participants will be randomized in this operationally seamless adaptive Phase 2/3 study. Phase 2 of the study will randomize approximately 164 participants into 4 arms, and Phase 3 of the study will randomize approximately 286 participants into 2 arms.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 2 Cohort MK-5475 380 µg
Arm Type
Experimental
Arm Description
Participants receive MK-5475 380 µg via oral inhalation once daily for 12 week base period and for optional 24 month extension period.
Arm Title
Phase 2 Cohort MK-5475 100 µg
Arm Type
Experimental
Arm Description
Participants receive MK-5475 100 µg via oral inhalation once daily for 12 week base period and for optional 24 month extension period.
Arm Title
Phase 2 Cohort MK-5475 32 µg
Arm Type
Experimental
Arm Description
Participants receive MK-5475 32 µg via oral inhalation once daily for 12 week base period and for optional 24 month extension period.
Arm Title
Phase 2 Cohort Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo via oral inhalation once daily for 12 week base period, and one of the MK-5475 doses (380, 100, or 32 µg) for the optional 24 month extension period.
Arm Title
Phase 3 Cohort MK-5475
Arm Type
Experimental
Arm Description
Participants receive one of 3 MK-5475 doses (380, 100 or 32 µg) to be selected at end of the Phase 2 Cohort, administered via oral inhalation once daily for 12-week base period and up to 60 months in the extension period
Arm Title
Phase 3 Cohort Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo via oral inhalation once daily for 12 week base period and up to 60 months in the extension period.
Intervention Type
Drug
Intervention Name(s)
MK-5475
Intervention Description
MK-5475 (soluble guanylate cyclase stimulator) 380 µg, 100 µg or 32 µg administered as dry powder inhalation
Intervention Type
Drug
Intervention Name(s)
Placebo to MK-5475
Intervention Description
Placebo administered as dry powder inhalation
Primary Outcome Measure Information:
Title
Phase 2 Cohort: Change from Baseline in Pulmonary Vascular Resistance (PVR) at 12 Weeks
Description
PVR is assessed by right heart catheterization (RHC).
Time Frame
At baseline and 12 weeks
Title
Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
Description
6MWD is assessed using the 6-minute walk test (6MWT).
Time Frame
At baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Phase 2 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
Description
6MWD is assessed using the 6-minute walk test (6MWT).
Time Frame
At baseline and 12 weeks
Title
Phase 2 Cohort: Change from Baseline in Mean Right Arterial Pressure (mRAP) at 12 Weeks
Description
mRAP is assessed by right heart catheterization (RHC).
Time Frame
At baseline and 12 weeks
Title
Phase 2 Cohort: Change from Baseline in Cardiac Index (CI) at 12 weeks
Description
Cardiac index is assessed by right heart catheterization (RHC).
Time Frame
At baseline and 12 weeks
Title
Phase 2 Cohort: Change from Baseline in Stroke Volume Index (SVI) at 12 weeks
Description
SVI is assessed by right heart catheterization (RHC).
Time Frame
At baseline and 12 weeks
Title
Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks
Description
6MWD is assessed using the 6-minute walk test (6MWT).
Time Frame
At baseline and 24 weeks
Title
Phase 3 Cohort: Change from Baseline in World Health Organization Functional Class (WHO-FC) at 12 Weeks
Description
Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase.
Time Frame
At baseline and 12 weeks
Title
Phase 2 Cohort: Number of Participants Who Experience an Adverse Event
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 2.25 years
Title
Phase 2 Cohort: Number of Participants Who Discontinue Study Drug Due to an Adverse Event
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 2.25 years
Title
Phase 3 Cohort: Number of Participants who Experience an Adverse Event
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 5.5 years
Title
Phase 3 Cohort: Number of Participants who Discontinue Study Drug Due to an Adverse Event
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 5.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pulmonary arterial hypertension (PAH) in one of the following groups: Idiopathic PAH Heritable PAH Drug and toxin-induced PAH PAH associated with connective tissue disease, HIV infection, or congenital heart disease. Diagnosis of PAH documented by right heart catheterization (RHC). Eligibility RHC meeting all of the following criteria: Mean pulmonary artery pressure (mPAP) ≥25 mmHg Pulmonary vascular resistance (PVR) of ≥3 Wood units Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg. World Health Organization functional class (WHO-FC) symptoms between Class II and IV. Two 6-Minute walk distance (6MWD) measurements between 150 and 500 meters, one at screening and one at randomization. Stable concomitant background PAH-specific therapy. Body Mass Index (BMI) between 18.5 kg/m² and 40 kg/m² . Agree to be abstinent from heterosexual intercourse or use contraception during the intervention period and for at least 14 days after the last dose of study intervention. Female participants may not be pregnant or breastfeeding. Exclusion Criteria: Group 2 to 5 pulmonary hypertension. PAH in one of the following groups: Long term responders to calcium channel blockers Overt features of venous/capillary involvement Evidence of more-than-mild obstructive lung disease. Evidence of more-than-mild parenchymal lung disease. Evidence of more-than-mild obstructive sleep apnea (OSA) that is untreated. Evidence or history of left heart disease, including any of the following: Left ventricular ejection fraction (LVEF) ≤45% Moderate or severe left-sided valvular disease (aortic or mitral valve stenosis or regurgitation) Significant left ventricular diastolic dysfunction on echocardiographic evaluation Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction: BMI>30 kg/m², essential systemic hypertension, diabetes mellitus of any type, or coronary artery disease. Oxygen saturation measured by pulse oximetry (SpO₂) <90%, despite supplemental oxygen therapy. Chronic renal insufficiency (eGFR <30 mL/min) Chronic liver disease (i.e., Child-Pugh B or C), portal hypertension, cirrhosis, or significant hepatic laboratory abnormalities. Current smoker or currently uses electronic cigarettes (vapes). History of cancer, except: nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated, with appropriate follow up, and unlikely to recur for the duration of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Diego Health-Pulmonary Critical Care ( Site 0061)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-7381
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
858-657-7122
Facility Name
University of California Davis Health-Internal Medicine: Pulmonary, Critical Care and Sleep Medicine
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
916-734-1554
Facility Name
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0063)
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
312-952-6750
Facility Name
University of Colorado - Denver ( Site 0003)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
720-848-0000
Facility Name
Cardiovascular Institute of North Colorado - Banner Health ( Site 0013)
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Individual Site Status
Completed
Facility Name
Georgetown University Hospital ( Site 0025)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Completed
Facility Name
University of Miami Hospital-Division of Pulmonary & Critical Care ( Site 0053)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
305-243-2568
Facility Name
AdventHealth Orlando ( Site 0040)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-303-7556
Facility Name
Tampa General Hospital ( Site 0058)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-964-7399
Facility Name
Indiana University Health Methodist Hospital ( Site 0045)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-1239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
317-962-9700
Facility Name
University of Iowa Hospital and Clinics ( Site 0009)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Completed
Facility Name
University of Kansas Medical Center ( Site 0038)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
913-588-4022
Facility Name
University of Kentucky ( Site 0006)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
859-323-0295
Facility Name
Norton Pulmonary Specialists ( Site 0048)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
502-587-8000
Facility Name
University of Maryland ( Site 0032)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
410-328-6885
Facility Name
Washington University School of Medicine ( Site 0066)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
901-834-7034
Facility Name
University of Nebraska Medical Center ( Site 0041)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
402-559-7585
Facility Name
University of New Mexico, Health Sciences Center ( Site 0028)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
505-272-4661
Facility Name
Clinical Trials Unit at Eastowne Medical Office Building ( Site 0019)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
984-974-2966
Facility Name
AnMed Health ( Site 0033)
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Completed
Facility Name
Statcare Pulmonary Consultants ( Site 0067)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
865-934-2672
Facility Name
University of Texas Southwestern Medical Center at Dallas ( Site 0012)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Houston Methodist Research Institute ( Site 0036)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
713-441-7182
Facility Name
The University of Texas Health Science Center at Houston ( Site 0054)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
281-908-7912
Facility Name
Sentara Norfolk General Hospital ( Site 0014)
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Completed
Facility Name
West Virginia University-WVU Heart and Vascular Institute ( Site 0051)
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
304-285-1980
Facility Name
Cardiologia Palermo ( Site 0140)
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1425BNG
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
541136606676
Facility Name
Hospital El Cruce Nestor Carlos Kirchner ( Site 0132)
City
Florencio Varela
State/Province
Buenos Aires
ZIP/Postal Code
1888
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5491158230726
Facility Name
Centro Medico Capital ( Site 0131)
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1904AAW
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5492215317279
Facility Name
Hospital Universitario Austral ( Site 0138)
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+54 230 448-2000
Facility Name
Instituto de Investigaciones Clinicas Quilmes ( Site 0141)
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Sanatorio de la Trinidad Mitre ( Site 0130)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
1039
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5491144799366
Facility Name
Instituto Cardiovascular de Rosario ( Site 0128)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSR
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+54 93416164246
Facility Name
Hospital Privado Universitario de Córdoba ( Site 0137)
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+54 351 468-8200
Facility Name
Nepean Hospital ( Site 0184)
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61247342000
Facility Name
Macquarie University ( Site 0180)
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61294226000
Facility Name
John Hunter Hospital ( Site 0185)
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0249214440
Facility Name
UZ Leuven ( Site 0600)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3216346833
Facility Name
Peter Lougheed Centre ( Site 0107)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4038305456
Facility Name
University Health Network - Toronto General Hospital ( Site 0104)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
416-340-4485
Facility Name
IUCPQ ( Site 0111)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
41865687112449
Facility Name
Centro Cardiovascular Colombiano Clínica Santa María ( Site 0154)
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+573136859942
Facility Name
Hospital Universitario San Ignacio ( Site 0152)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110231
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5712882284
Facility Name
Fundacion Cardiovascular de Colombia ( Site 0155)
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
681017
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+573175741421
Facility Name
CHRU Brest - Hopital Cavale Blanche ( Site 0254)
City
Brest
State/Province
Finistere
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33298223333
Facility Name
CHU de Toulouse - Hopital Larrey ( Site 0258)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33556795679
Facility Name
Institut Coeur Poumon - CHRU de Lille ( Site 0252)
City
Lille Cedex
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33320445721
Facility Name
Centre Hospitalier Universitaire de Rouen ( Site 0253)
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33232885406
Facility Name
CHU - Hopital de Bicetre ( Site 0251)
City
Le Kremlin-Bicetre
State/Province
Val-de-Marne
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33145212121
Facility Name
Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0276)
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 6221 396-8076
Facility Name
Klinikum Würzburg Mitte-Medizinische Klinik - Schwerpunkt Pneumologie & Beatmungsmedizin ( Site 0280
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00499317910
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH ( Site 0279)
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4964198560
Facility Name
Medizinische Hochschule Hannover ( Site 0284)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 511 532 3548
Facility Name
Uniklinikum Dresden ( Site 0283)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 3513177238
Facility Name
Universitaetsklinikum Leipzig ( Site 0285)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493419716250
Facility Name
AHEPA University General Hospital of Thessaloniki ( Site 0577)
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302310994830
Facility Name
Soroka Medical Center ( Site 0330)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97286403832
Facility Name
Rambam Medical Center ( Site 0335)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97250206171
Facility Name
Wolfson Medical Center [Holon, Israel] ( Site 0333)
City
Holon
ZIP/Postal Code
5810000
Country
Israel
Individual Site Status
Completed
Facility Name
Shaare Zedek Medical Center ( Site 0331)
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972506865209
Facility Name
Rabin Medical Center ( Site 0327)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97239377221
Facility Name
University of Naples Federico II ( Site 0308)
City
Naples
State/Province
Campania
ZIP/Postal Code
80100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390817462242
Facility Name
Azienda Ospedaliera Policlinico Umberto I ( Site 0301)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390649979016
Facility Name
Ospedale San Gerardo - ASST Monza ( Site 0304)
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390392339245
Facility Name
Centro Cardiologico Monzino IRCCS ( Site 0306)
City
Milano
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390258002299
Facility Name
Fondazione IRCCS Policlinico San Matteo ( Site 0302)
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390382503460
Facility Name
Consultorio 1020 Hospital Angeles Xalapa ( Site 0654)
City
Xalapa
State/Province
Veracruz
ZIP/Postal Code
91193
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+522281084321
Facility Name
Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas ( Site 0653)
City
Huixquilucan
ZIP/Postal Code
52763
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5552469709
Facility Name
Instituto Nacional de Cardiología -Ignacio Chavez ( Site 0651)
City
Mexico D.F
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5555732911
Facility Name
Christchurch Hospital ( Site 0201)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+64274677583
Facility Name
Greenlane Clinical Centre ( Site 0203)
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6493074949x21646
Facility Name
Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0351)
City
Walbrzych
State/Province
Dolnoslaskie
ZIP/Postal Code
58-309
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48746489622
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie ( Site 0352)
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-954
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
601366148
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawa II-Oddzial Kliniczny Chorob Serca i Naczyn z Pododd
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+485000099734
Facility Name
Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 0403)
City
Kemerovo
State/Province
Kemerovskaya Oblast
ZIP/Postal Code
650002
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Almazov National Medical Research Centre of the Ministry of Health ( Site 0402)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Akademiska sjukhuset ( Site 0453)
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46186114954
Facility Name
Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0452)
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46313427557
Facility Name
Ege Universitesi Hastanesi-Cardilogy Department ( Site 0504)
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324123489
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0510)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
903123055000
Facility Name
Akdeniz Uni.Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi ( Site 0508)
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+902422496770
Facility Name
Eskisehir Osmangazi Uni. Tip Fakultesi Hastanesi ( Site 0506)
City
Eskisehir
ZIP/Postal Code
26040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905332337849
Facility Name
Istanbul Uni. Kardiyoloji Enstitusu ( Site 0502)
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905322860797
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0509)
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905322831726
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0501)
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+902166254545
Facility Name
Dokuz Eylul University Faculty of Medicine ( Site 0505)
City
Izmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+902324122210
Facility Name
Golden Jubilee National Hospital ( Site 0556)
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441419515497
Facility Name
Royal Brompton and Harefield NHS Trust ( Site 0553)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4402073518362
Facility Name
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0554)
City
London
State/Province
London, City Of
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
07971655079
Facility Name
The Freeman Hosp.Newcastle upon Tyne Hosp NHS Trust ( Site 0552)
City
Newcastle-upon-Tyne
State/Province
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441912231608

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=5475-007&&kw=5475-007
Description
Plain Language Summary

Learn more about this trial

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

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