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A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500877-15-00
Acronym
MK-5475-007
Enrollment
68
Registered
2023-06-07
Start date
2021-06-25
Completion date
2024-04-23
Last updated
2024-04-08

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

Conditions

Drug and toxin-induced PAH, Heritable PAH, HIV infection, or congenital heart disease, PAH associated with connective tissue disease, Pulmonary arterial hypertension (PAH) in one of the following groups: Idiopathic PAH

Brief summary

Phase 2 Cohort: Change from Baseline in Pulmonary Vascular Resistance (PVR) at 12 Weeks, Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks

Detailed description

Phase 2 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks, Phase 2 Cohort: Change from Baseline in Mean Right Arterial Pressure (mRAP) at 12 Weeks, Phase 2 Cohort: Change from Baseline in Cardiac Index (CI) at 12 weeks, Phase 2 Cohort: Change from Baseline in Stroke Volume Index (SVI) at 12 weeks, Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks, Phase 3 Cohort: Change from Baseline in World Health Organization Functional Class (WHO-FC) at 12 Weeks, Phase 2 and 3 Cohorts: Number of Participants Who Experience an Adverse Event, Phase 2 and 3 Cohorts: Number of Participants Who Discontinue Study Drug Due to an Adverse Event

Interventions

DRUGPlacebo to MK-5475

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase 2 Cohort: Change from Baseline in Pulmonary Vascular Resistance (PVR) at 12 Weeks, Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks

Secondary

MeasureTime frame
Phase 2 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks, Phase 2 Cohort: Change from Baseline in Mean Right Arterial Pressure (mRAP) at 12 Weeks, Phase 2 Cohort: Change from Baseline in Cardiac Index (CI) at 12 weeks, Phase 2 Cohort: Change from Baseline in Stroke Volume Index (SVI) at 12 weeks, Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks, Phase 3 Cohort: Change from Baseline in World Health Organization Functional Class (WHO-FC) at 12 Weeks, Phase 2 and 3 Cohorts: Number of Participants Who Experience an Adverse Event, Phase 2 and 3 Cohorts: Number of Participants Who Discontinue Study Drug Due to an Adverse Event

Countries

Belgium, France, Germany, Greece, Italy, Poland, Sweden

Outcome results

None listed

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