Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH) (JPMS-CTEPH)

  • STATUS
    Recruiting
  • End date
    Jan 16, 2024
  • participants needed
    1298
  • sponsor
    Bayer
Updated on 16 September 2022
riociguat
chronic thromboembolic pulmonary hypertension
adempas

Summary

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.

Details
Condition Hypertension, Pulmonary
Treatment Riociguat (ADEMPAS, BAY63-2521)
Clinical Study IdentifierNCT02117791
SponsorBayer
Last Modified on16 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who are treated with Riociguat for CTEPH

Exclusion Criteria

Patients who are contraindicated based on the product label
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