Trial Condition(s):

Hypertension, Pulmonary

Prospective, non-interventional, multi-center, post-authorization safety study of Riociguat for Pulmonary Arterial Hypertension (PAH) (JPMS-PAH)

Bayer Identifier:

17519

ClinicalTrials.gov Identifier:

NCT02428985

EudraCT Number:

Not Available

Recruiting

Trial Purpose

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.

Inclusion Criteria
- Patients who are treated with Riociguat for PAH
Exclusion Criteria
- N/A

Trial Summary

Enrollment Goal
600
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Japan

Status
Recruiting
 

Trial Design