Trial Condition(s):

Hypertension, Pulmonary

Prospective, non-interventional, multi-center post-authorization safety study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH ) (JPMS-CTEPH)

Bayer Identifier:

16843

ClinicalTrials.gov Identifier:

NCT02117791

EudraCT Number:

Not Available

Recruiting

Trial Purpose

This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.

Inclusion Criteria
- Patients who are treated with Riociguat for CTEPH
Exclusion Criteria
- Patients who are contraindicated based on the product label

Trial Summary

Enrollment Goal
1298
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Recruiting
 

Trial Design