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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
Secondary outcome measures
Mean Change From Baseline in 6MWD at Week 12
Nesiritide
Mean Change From Baseline in NT-ProBNP at Week 24
+4 moreTrial 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 1
~50
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,054,884 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,744 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the eligibility requirement for this experiment extend beyond those under 25 years of age?
"This trial mandates that participants fall within the 40-80 age range. Currently, there are 57 clinical trials for minors and 660 for elderly individuals."
Answered by AI
Who meets the criteria to take part in this clinical research?
"This clinical study is seeking 120 people with pulmonary hypertension aged between 40 and 80. For consideration, applicants must adhere to the following criteria: The fundamental inclusion requirement."
Answered by AI
Are patients able to partake in this clinical investigation?
"As per the information available on clinicialtrials.gov, this medical trial is presently recruiting potential participants. The study was initially published on January 27th 2023 and recently updated on August 1st 2023."
Answered by AI
What potential adverse effects have been observed with the administration of MK-5475?
"MK-5475's safety is rated a 2, as it has been through one round of clinical data providing insight into its safety profile but no trials testing efficacy yet."
Answered by AI
To what extent has enrollment for this clinical trial been successful?
"Affirmative. According to clinicaltrials.gov, the trial initiated on January 27th 2023 and was recently updated on 1/8/2023 is currently looking for 120 patients from a single location."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
What site did they apply to?
Mayo Clinic in Rochester, Minnesota ( Site 0131)
What portion of applicants met pre-screening criteria?
Met criteria
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