MK-5475 for Pulmonary Hypertension

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pulmonary HypertensionMK-5475 - Drug
Eligibility
40 - 80
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Pulmonary Hypertension

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to Week 104

Baseline and Week 12
Mean Change From Baseline in 6MWD at Week 12
Nesiritide
Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12
Baseline and Week 24
Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
Mean Change From Baseline in NT-ProBNP at Week 24
Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24
Up to Week 102
Percentage of Participants who Discontinued Study Treatment due to an AE
Up to Week 104
Percentage of Participants With One or More Adverse Events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

MK-5475 480 ug: Part 2 Period 1 (Panel D)
25%Blood bilirubin increased
25%Blood creatinine increased
This histogram enumerates side effects from a completed 2020 Phase 1 trial (NCT03744637) in the MK-5475 480 ug: Part 2 Period 1 (Panel D) ARM group. Side effects include: Blood bilirubin increased with 25%, Blood creatinine increased with 25%.

Trial Design

2 Treatment Groups

MK-5475
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

120 Total Participants · 2 Treatment Groups

Primary Treatment: MK-5475 · Has Placebo Group · Phase 2

MK-5475
Drug
Experimental Group · 1 Intervention: MK-5475 · Intervention Types: Drug
PlaceboPlaceboComparator Group · 2 Interventions: Placebo, MK-5475 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-5475
2019
Completed Phase 1
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 104

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,681 Previous Clinical Trials
4,957,331 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,638 Previous Clinical Trials
7,941,857 Total Patients Enrolled

Eligibility Criteria

Age 40 - 80 · All Participants · 1 Total Inclusion Criteria

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