Efficacy and safety of riociguat (MK-4836) in incipient pulmonary vascular disease as an indicator for early pulmonary arterial hypertension Double-blind, randomized, multicenter, multinational, placebo-controlled phase IIa study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509695-42-00

Acronym

2020-01RCT

Enrollment

Registered

2024-11-07

Start date

2022-07-25

Completion date

2025-07-31

Last updated

2025-04-30

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

Conditions

Pulmonary vascular disease

Brief summary

Pulmonary vascular resistance, change from baseline to 24 weeks

Detailed description

change of cardiac index at rest (baseline to 24 weeks), change of total pulmonary resistance (baseline to 24 weeks), change of diffusion capacity of the lung (baseline to 24 weeks), change of 6-minute walking distance (baseline to 24 weeks), change of WHO functional class (baseline to 24 weeks), change in QoL (SF-36, physical summation score; baseline to 24 weeks)

Interventions

DRUGRiociguat Bayer

DRUGCellulose microcrystaline; lactose monohydrate; magnesium stearate

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Pulmonary vascular resistance, change from baseline to 24 weeks	—

Secondary

Measure	Time frame
change of cardiac index at rest (baseline to 24 weeks), change of total pulmonary resistance (baseline to 24 weeks), change of diffusion capacity of the lung (baseline to 24 weeks), change of 6-minute walking distance (baseline to 24 weeks), change of WHO functional class (baseline to 24 weeks), change in QoL (SF-36, physical summation score; baseline to 24 weeks)	—

Countries

Austria, France, Germany, Italy

Outcome results

None listed

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