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sGC Stimulator
Inhaled sGC Stimulator for Pulmonary Hypertension and COPD
Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 104
Summary
This trial will assess if a medication called MK-5475 can safely improve walking and exercise capacity in people with Pulmonary Hypertension associated with COPD. #COPD #PulmonaryHypertension
Who is the study for?
Adults aged 40-85 with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD) can join this trial. They must have stable oxygen, anticoagulant, and COPD therapy regimens, and not be pregnant or planning a transplant. Exclusions include significant heart disease, recent severe COPD exacerbations, certain past medical conditions like cancer or drug abuse.
What is being tested?
The study tests the effectiveness of MK-5475 (an inhaled sGC stimulator) against a placebo in improving walking distance over six minutes after 24 weeks. Participants will use MK-5475 daily through inhalation to see if it helps better than a non-active treatment.
What are the potential side effects?
While specific side effects for MK-5475 are not listed here, common ones for new respiratory treatments may include coughing, throat irritation, headache, nausea and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 104
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
Secondary study objectives
Mean Change From Baseline in 6MWD at Week 12
Nesiritide
Mean Change From Baseline in NT-ProBNP at Week 24
+4 moreSide effects data
From 2022 Phase 1 trial • 22 Patients • NCT0437087333%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (Part 2)
MK-5475 360 µg (Part 1)
Placebo (Part 1)
MK-5475 380 µg (Part 2)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-5475Experimental Treatment1 Intervention
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).
Group II: PlaceboPlacebo Group2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-5475
2019
Completed Phase 3
~220
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,031 Previous Clinical Trials
5,189,582 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,090,865 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a serious COPD flare-up in the last 2 months.I started a lung rehab program within the last 2 months.My oxygen use is consistent and hasn't changed recently.My COPD treatment is stable and optimized.I am between 40 and 85 years old.I have had right heart failure in the last 2 months.I have untreated sleep apnea that is more than mild.I have an irregular, very fast heartbeat that isn't controlled.I am expected to receive a lung and/or heart transplant within the next 24 weeks.My heart condition affects my daily activities.I have long-term kidney problems.I have had cancer in the past.I have been diagnosed with a specific type of high blood pressure in the lungs.I am not pregnant, breastfeeding, and either cannot become pregnant or am using birth control.I am on a stable dose of blood thinners.My blood pressure medication has been stable.I've had a recent heart attack or heart surgery in the last 2 months.I have a chronic liver condition or cirrhosis.My doctor diagnosed me with obstructive lung disease based on a lung function test.I have high blood pressure in my lungs due to chronic lung disease.I cannot complete a 6-minute walk test due to my condition.I have pulmonary hypertension not caused by COPD.I have a serious heart condition affecting the left side.I have taken medication for pulmonary arterial hypertension in the last 2 months.I have been on a stable dose of a PDE5 inhibitor for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: MK-5475
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.