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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501201-13-00

Acronym

MK-5475-013

Enrollment

Registered

2023-01-23

Start date

2023-03-01

Completion date

Unknown

Last updated

2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD).

Brief summary

Mean change from baseline in 6-minute walk distance (6MWD) at Week 24

Detailed description

Mean change from baseline in 6MWD at Week 12, Mean change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) at Week 12, Mean change from baseline in NT-proBNP at Week 24, Percentage of participants whose World Health Organization (WHO) Functional Class does not worsen relative to baseline at Week 12, Percentage of participants whose WHO Functional Class does not worsen relative to baseline at Week 24, Percentage of participants with one or more adverse events (AEs), Percentage of participants who discontinued study treatment due to an AE

Interventions

DRUGMK-5475

DRUGPlacebo for MK-5475

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in 6-minute walk distance (6MWD) at Week 24	—

Secondary

Measure	Time frame
Mean change from baseline in 6MWD at Week 12, Mean change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) at Week 12, Mean change from baseline in NT-proBNP at Week 24, Percentage of participants whose World Health Organization (WHO) Functional Class does not worsen relative to baseline at Week 12, Percentage of participants whose WHO Functional Class does not worsen relative to baseline at Week 24, Percentage of participants with one or more adverse events (AEs), Percentage of participants who discontinued study treatment due to an AE	—

Measure

Time frame

—

Countries

Austria, Belgium, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026