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Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH)

NCT02428985 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 882

Last updated 2024-01-29

No results posted yet for this study

Summary

The primary objective in this study is to collect post-marketing information on Riociguat safety.Thus, the information on adverse events (AEs) and adverse drug reactions (ADRs) that occur within the first 12 months and in the following 6 -year observation at most, after starting Riociguat treatment under the routine clinical practice will be collected.

The secondary objectives are collecting information on Riociguat effectiveness, such as 6-Minute Walking Distance (6MWD) Test. Since it is assumed that Riociguat is for long-term use, information on Pulmonary Arterial Hypertension (PAH) clinical worsening will also be surveyed once a year.

Conditions

  • Hypertension, Pulmonary

Interventions

DRUG

Riociguat (ADEMPAS, BAY63-2521)

The treatment of Riociguat should comply with the local product information

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-29
Primary Completion
2023-04-17
Completion
2023-09-20

Countries

  • Japan

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Entities

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 NCT02428985 on ClinicalTrials.gov