Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )

NCT ID: NCT02117791

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1298 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-16
• Study Completion Date: 2023-09-20

Brief 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.

Conditions

Hypertension, Pulmonary

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Riociguat treatment group

Riociguat (ADEMPAS, BAY63-2521)

Intervention Type: DRUG

The treatment of Riociguat should comply with the local product information (start dose: 3 mg/day, maximum dose: 7.5 mg/day)

Interventions

Riociguat (ADEMPAS, BAY63-2521)

The treatment of Riociguat should comply with the local product information (start dose: 3 mg/day, maximum dose: 7.5 mg/day)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who are treated with Riociguat for CTEPH

Exclusion Criteria

• Patients who are contraindicated based on the product label

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Multiple Locations, , Japan

Countries

Japan

References

Tanabe N, Ogo T, Hatano M, Kigawa A, Sunaya T, Sato S. Safety and effectiveness of riociguat for chronic thromboembolic pulmonary hypertension in real-world clinical practice: interim data from post-marketing surveillance in Japan. Pulm Circ. 2020 Jul 23;10(3):2045894020938986. doi: 10.1177/2045894020938986. eCollection 2020 Jul-Sep.

Reference Type: DERIVED

PMID: 32754307 (View on PubMed)

Other Identifiers

ADEMPAS-CTEPH

Identifier Type: OTHER

Identifier Source: secondary_id

16843

Identifier Type: -

Identifier Source: org_study_id