search
Back to results

MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator) in Adults With PH-COPD

Primary Purpose

Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

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

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension. Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria. Has evidence of obstructive lung disease on pulmonary function testing (PFT) performed at screening. Has a WHO Functional Class assessment of Class II to IV. If on supplemental oxygen, the regimen must be stable. Has stable and optimized chronic, baseline COPD-specific therapy. If on antihypertensives and/or a diuretic regimen has stable concomitant use. If on anticoagulants has stable concomitant use. Is of any sex/gender from 40 to 80 years of age inclusive. Female is not pregnant or breastfeeding, and is not of childbearing potential or uses acceptable contraceptive method or abstains from sexual intercourse, or has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention, or whose history and sexual activity has been reviewed by the investigator. Exclusion criteria: Has history of Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH). Has history of non-COPD related Group 3 PH. Has evidence of untreated more than mild obstructive sleep apnea. Has evidence or history of left heart disease. Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period. Has evidence of a resting oxygen saturation (SpO2) < 90%. Has experienced a moderate or severe COPD exacerbation within 2 months before randomization. Has experienced right heart failure within 2 months before randomization. Has uncontrolled tachyarrhythmia. Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization. Has evidence of significant chronic renal insufficiency. Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities. Initiated a pulmonary rehabilitation program within 2 months before randomization. Has impairments that limit the ability to perform 6MWT. Has history of cancer. Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence. Has used PAH-specific therapies within 2 months of randomization.

Sites / Locations

  • University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and VascularRecruiting
  • Clinovation Intl. Corp. ( Site 0108)Recruiting
  • Alexian Brothers Medical Center-Pulmonary ( Site 0109)Recruiting
  • University of Iowa ( Site 0103)Recruiting
  • University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102)Recruiting
  • Lexington VA Medical Center - Cooper Division ( Site 0137)Recruiting
  • Mayo Clinic in Rochester, Minnesota ( Site 0131)Recruiting
  • Creighton University Clinical Research Office ( Site 0123)Recruiting
  • Temple University Hospital ( Site 0104)Recruiting
  • The University of Texas Health Science Center at Houston ( Site 0105)Recruiting
  • University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111)Recruiting
  • Centro Medico Capital ( Site 0301)Recruiting
  • Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303)Recruiting
  • Fundación Respirar ( Site 0305)Recruiting
  • Hospital Privado Universitario de Córdoba-Clinical Cardiology Department ( Site 0302)Recruiting
  • Westmead Hospital-Department of Respiratory and Sleep Medicine ( Site 0902)Recruiting
  • The Prince Charles Hospital ( Site 0904)Recruiting
  • Mater Misericordiae Limited ( Site 0905)Recruiting
  • Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201)Recruiting
  • Medizinische Universitaet Innsbruck ( Site 1202)Recruiting
  • Centro Cardiovascular Colombiano Clínica Santa María ( Site 0504)Recruiting
  • Ciensalud Ips S A S ( Site 0508)Recruiting
  • Fundacion Valle del Lili- CIC ( Site 0509)Recruiting
  • Centro de Investigaciones Clinicas SAS ( Site 0505)Recruiting
  • C.H.U Hôpital Nord ( Site 1503)Recruiting
  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501)Recruiting
  • Centre Hospitalier Universitaire de Poitiers ( Site 1505)Recruiting
  • Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 1603)Recruiting
  • Medizinische Hochschule Hannover ( Site 1602)Recruiting
  • Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601)Recruiting
  • Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605)Recruiting
  • Rambam Health Care Campus ( Site 1701)Recruiting
  • Cattinara Hospital ( Site 1801)Recruiting
  • Ospedale San Gerardo-ASST Monza-Cardio Vasolare- Clinica pneumologica ( Site 1802)Recruiting
  • ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ( Site 1804)Recruiting
  • Gachon University Gil Medical Center ( Site 1101)Recruiting
  • Seoul National University Hospital ( Site 1103)Recruiting
  • Asan Medical Center ( Site 1102)Recruiting
  • Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701)Recruiting
  • Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003)Recruiting
  • HOSPITAL CLÍNIC DE BARCELONA ( Site 2001)Recruiting
  • Hospital Universitari Vall d'Hebron ( Site 2002)Recruiting
  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005)Recruiting
  • UniversitätsSpital Zürich ( Site 2201)Recruiting
  • Cantonal Hospital St.Gallen ( Site 2203)Recruiting
  • Hammersmith Hospital-Department of Cardiology ( Site 2401)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MK-5475

Placebo

Arm Description

Participants with PH-COPD will receive 380 µg of MK-5475 as an oral inhalation once daily for 24 weeks (base period) and thereafter for 18 months (optional extension period).

Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of MK-5475 as an oral inhalation once daily for 18 months (optional extension period).

Outcomes

Primary Outcome Measures

Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
6MWD is assessed using the 6-minute walk test (6MWT).

Secondary Outcome Measures

Mean Change From Baseline in 6MWD at Week 12
6MWD is assessed using the 6-minute walk test (6MWT).
Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12
NT-proBNP was measured at baseline and Week 12.
Mean Change From Baseline in NT-ProBNP at Week 24
NT-proBNP was measured at baseline and Week 24
Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12
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.
Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24
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.
Percentage of Participants With One or More Adverse Events (AEs)
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.
Percentage of Participants who Discontinued Study Treatment due to an AE
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. The percentage of participants who discontinue study treatment due to an AE will be presented.

Full Information

First Posted
November 3, 2022
Last Updated
October 19, 2023
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT05612035
Brief Title
MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator) in Adults With PH-COPD
Official Title
A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
March 14, 2025 (Anticipated)
Study Completion Date
September 15, 2026 (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
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of once daily oral inhalation dose of MK-5475 380 µg in participants 40 to 80 years (inclusive) with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD). The primary hypothesis of the study is MK-5475, a soluble Guanylate Cyclase (sGC) stimulator is superior to placebo in increasing 6 Minute Walking Distance (6MWD) from baseline at Week 24.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MK-5475
Arm Type
Experimental
Arm Description
Participants with PH-COPD will receive 380 µg of MK-5475 as an oral inhalation once daily for 24 weeks (base period) and thereafter for 18 months (optional extension period).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of MK-5475 as an oral inhalation once daily for 18 months (optional extension period).
Intervention Type
Drug
Intervention Name(s)
MK-5475
Intervention Description
MK-5475 380 µg administered as dry powder inhalation once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered as dry powder inhalation once daily.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
Description
6MWD is assessed using the 6-minute walk test (6MWT).
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in 6MWD at Week 12
Description
6MWD is assessed using the 6-minute walk test (6MWT).
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12
Description
NT-proBNP was measured at baseline and Week 12.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in NT-ProBNP at Week 24
Description
NT-proBNP was measured at baseline and Week 24
Time Frame
Baseline and Week 24
Title
Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12
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
Baseline and Week 12
Title
Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24
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
Baseline and Week 24
Title
Percentage of Participants With One or More Adverse Events (AEs)
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 Week 104
Title
Percentage of Participants who Discontinued Study Treatment due to an AE
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. The percentage of participants who discontinue study treatment due to an AE will be presented.
Time Frame
Up to Week 102

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension. Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria. Has evidence of obstructive lung disease on pulmonary function testing (PFT) performed at screening. Has a WHO Functional Class assessment of Class II to IV. If on supplemental oxygen, the regimen must be stable. Has stable and optimized chronic, baseline COPD-specific therapy. If on antihypertensives and/or a diuretic regimen has stable concomitant use. If on anticoagulants has stable concomitant use. Is of any sex/gender from 40 to 80 years of age inclusive. Female is not pregnant or breastfeeding, and is not of childbearing potential or uses acceptable contraceptive method or abstains from sexual intercourse, or has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention, or whose history and sexual activity has been reviewed by the investigator. Exclusion criteria: Has history of Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH). Has history of non-COPD related Group 3 PH. Has evidence of untreated more than mild obstructive sleep apnea. Has evidence or history of left heart disease. Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period. Has evidence of a resting oxygen saturation (SpO2) < 90%. Has experienced a moderate or severe COPD exacerbation within 2 months before randomization. Has experienced right heart failure within 2 months before randomization. Has uncontrolled tachyarrhythmia. Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization. Has evidence of significant chronic renal insufficiency. Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities. Initiated a pulmonary rehabilitation program within 2 months before randomization. Has impairments that limit the ability to perform 6MWT. Has history of cancer. Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence. Has used PAH-specific therapies within 2 months of randomization.
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 Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular
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
Clinovation Intl. Corp. ( Site 0108)
City
Sebring
State/Province
Florida
ZIP/Postal Code
33870
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
863-314-8971
Facility Name
Alexian Brothers Medical Center-Pulmonary ( Site 0109)
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
224-273-2387
Facility Name
University of Iowa ( Site 0103)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
319-353-5236
Facility Name
University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102)
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
913-588-6045
Facility Name
Lexington VA Medical Center - Cooper Division ( Site 0137)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
859-233-4511
Facility Name
Mayo Clinic in Rochester, Minnesota ( Site 0131)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
800-752-1606
Facility Name
Creighton University Clinical Research Office ( Site 0123)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
402-280-4146
Facility Name
Temple University Hospital ( Site 0104)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-707-1359
Facility Name
The University of Texas Health Science Center at Houston ( Site 0105)
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
713-486-6159
Facility Name
University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
434-243-6074
Facility Name
Centro Medico Capital ( Site 0301)
City
La PLata
State/Province
Buenos Aires
ZIP/Postal Code
1904
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
005492215317279
Facility Name
Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303)
City
San Miguel de Tucumán
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
54 0381 15 5339802
Facility Name
Fundación Respirar ( Site 0305)
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
01170781548
Facility Name
Hospital Privado Universitario de Córdoba-Clinical Cardiology Department ( Site 0302)
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5493516263892
Facility Name
Westmead Hospital-Department of Respiratory and Sleep Medicine ( Site 0902)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+612 8890 6797
Facility Name
The Prince Charles Hospital ( Site 0904)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61731394511
Facility Name
Mater Misericordiae Limited ( Site 0905)
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61731632128
Facility Name
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4331638512183
Facility Name
Medizinische Universitaet Innsbruck ( Site 1202)
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4366473410485
Facility Name
Centro Cardiovascular Colombiano Clínica Santa María ( Site 0504)
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
573122957048
Facility Name
Ciensalud Ips S A S ( Site 0508)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
08001
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3108059885
Facility Name
Fundacion Valle del Lili- CIC ( Site 0509)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
573155006300
Facility Name
Centro de Investigaciones Clinicas SAS ( Site 0505)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760036
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3162878747
Facility Name
C.H.U Hôpital Nord ( Site 1503)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13915
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33491966137
Facility Name
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501)
City
Le Kremlin-Bicêtre
State/Province
Paris
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3345217976
Facility Name
Centre Hospitalier Universitaire de Poitiers ( Site 1505)
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0549444444
Facility Name
Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 1603)
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
00496221 396 8053
Facility Name
Medizinische Hochschule Hannover ( Site 1602)
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
495115323531
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601)
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 35145813981
Facility Name
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605)
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4945150045000
Facility Name
Rambam Health Care Campus ( Site 1701)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972548944992
Facility Name
Cattinara Hospital ( Site 1801)
City
Trieste
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
34149
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390403994665
Facility Name
Ospedale San Gerardo-ASST Monza-Cardio Vasolare- Clinica pneumologica ( Site 1802)
City
Monza
State/Province
Lombardia
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
ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ( Site 1804)
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0912192111
Facility Name
Gachon University Gil Medical Center ( Site 1101)
City
Namdong-gu
State/Province
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-10-3313-7129
Facility Name
Seoul National University Hospital ( Site 1103)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82220720243
Facility Name
Asan Medical Center ( Site 1102)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0230103994
Facility Name
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701)
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5544429416
Facility Name
Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34 942 20 35 65
Facility Name
HOSPITAL CLÍNIC DE BARCELONA ( Site 2001)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34 932275779
Facility Name
Hospital Universitari Vall d'Hebron ( Site 2002)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34 932746157
Facility Name
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0034667956480
Facility Name
UniversitätsSpital Zürich ( Site 2201)
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+41797962829
Facility Name
Cantonal Hospital St.Gallen ( Site 2203)
City
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
43714943692
Facility Name
Hammersmith Hospital-Department of Cardiology ( Site 2401)
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
07701040851

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=5475-013&&kw=5475-013
Description
Plain Language Summary

Learn more about this trial

MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator) in Adults With PH-COPD

We'll reach out to this number within 24 hrs