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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05612035
Registration number
NCT05612035
Ethics application status
Date submitted
3/11/2022
Date registered
10/11/2022
Date last updated
6/05/2024
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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MK-5475-013
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Secondary ID [2]
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5475-013
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension
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Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MK-5475
Treatment: Drugs - Placebo
Experimental: MK-5475 - 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).
Placebo Comparator: Placebo - 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).
Treatment: Drugs: MK-5475
MK-5475 380 µg administered as dry powder inhalation once daily.
Treatment: Drugs: Placebo
Placebo administered as dry powder inhalation once daily.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
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Assessment method [1]
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6MWD is assessed using the 6-minute walk test (6MWT).
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [1]
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Mean Change From Baseline in 6MWD at Week 12
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Assessment method [1]
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6MWD is assessed using the 6-minute walk test (6MWT).
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12
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Assessment method [2]
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NT-proBNP was measured at baseline and Week 12.
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Timepoint [2]
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Baseline and Week 12
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Secondary outcome [3]
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Mean Change From Baseline in NT-ProBNP at Week 24
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Assessment method [3]
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NT-proBNP was measured at baseline and Week 24
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Timepoint [3]
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Baseline and Week 24
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Secondary outcome [4]
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Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and Week 12
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Secondary outcome [5]
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Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and Week 24
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Secondary outcome [6]
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Percentage of Participants With One or More Adverse Events (AEs)
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Assessment method [6]
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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.
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Timepoint [6]
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Up to Week 104
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Secondary outcome [7]
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Percentage of Participants who Discontinued Study Treatment due to an AE
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Assessment method [7]
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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.
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Timepoint [7]
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Up to Week 102
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Eligibility
Key inclusion criteria
The key inclusion and exclusion criteria include but are not limited to the following:
- 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 a physician diagnosis 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 PDE5 inhibitor, has stable concomitant use (initiated at least 3 months prior to
randomization and no change in drug or dosage for at least 3 months prior to
randomization) and changes to PDE5 inhibitor dosing is not anticipated during the 24
week Base Period.
- 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 85 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.
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Minimum age
40
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary
hypertension (PH).
- Has non-COPD related Group 3 PH.
- Has evidence of untreated more than mild obstructive sleep apnea.
- Has significant 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) < 88%.
- 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
23/03/2028
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Westmead Hospital-Department of Respiratory and Sleep Medicine ( Site 0902) - Westmead
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Recruitment hospital [2]
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The Prince Charles Hospital ( Site 0904) - Brisbane
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Recruitment hospital [3]
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Mater Misericordiae Limited ( Site 0905) - South Brisbane
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4032 - Brisbane
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment outside Australia
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United States of America
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Colorado
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Florida
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United States of America
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Illinois
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Iowa
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Kansas
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Kentucky
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Tucuman
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Argentina
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Cordoba
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Antioquia
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Atlantico
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Colombia
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Paris
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Vienne
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Germany
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Germany
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Germany
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Haifa
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Israel
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Petah Tikva
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Italy
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Palermo
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Korea, Republic of
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Incheon
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Lima
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Gauteng
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Cataluna
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Barcelona
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Zurich
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Switzerland
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Sankt Gallen
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Turkey
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Ankara
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Turkey
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Eskisehir
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Turkey
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Istanbul
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United Kingdom
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London, City Of
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 85 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05612035
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toll Free Number
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Address
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05612035
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