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Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH

NCT05339087 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-01-21

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled, multicenter, multinational study investigating the effect of riociguat (MK-4836) in patients with early pulmonary vascular disease.

Conditions

  • Pulmonary Vascular Disorder
  • Primary Pulmonary Hypertension
  • Systemic Sclerosis
  • Other Systemic Involvement of Connective Tissue

Interventions

DRUG

Riociguat Oral Tablet

Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) Titration phase: dose will be individually adjusted in accordance with the in-label titration regimen. Dose adjustment will be performed every two weeks by phone taking the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions into account. At week 8 the maintenance dose will be established and continued for the rest of the study

OTHER

Placebo

Sham titration and adjustment to maintenance dose will be performed according to individual tolerability as in the experimental arm.

Sponsors & Collaborators

Principal Investigators

  • Ekkehard Grünig, MD · Thoraxklinik at the University of Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-24
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Austria
  • France
  • Germany
  • Italy
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05339087 on ClinicalTrials.gov