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

Hypertension, Pulmonary Clinical Trial

— JPMS-CTEPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117791
• Other study ID #: 16843
• Secondary ID: ADEMPAS-CTEPH
• Status: Completed
• Start date: July 16, 2014
• Est. completion date: September 20, 2023

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1298
• Est. completion date: September 20, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who are treated with Riociguat for CTEPH

Exclusion Criteria:

• Patients who are contraindicated based on the product label

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment emergent adverse events and adverse drug reactions		up to 8 years
Secondary	Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months		baseline and 4 months, and 12 months
Secondary	Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months		baseline and 4 months, and 12 months
Secondary	Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months		baseline and 4 months, and 12 months
Secondary	Change from baseline in BNP/NT-pro BNP after 4 and 12 months		baseline and 4 months, and 12 months
Secondary	Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months		baseline and 4 months, and 12 months
Secondary	Time to Clinical Worsening	The first occurrence of the following events is recorded and will be considered for the calculation of the combined endpoint: • Death (all-cause mortality) • Heart/lung transplantation • Rescue Pulmonary Endarterectomy, Rescue Balloon Pulmonary Angioplasty or Hospitalization due to persistent worsening of Pulmonary Hypertension • Start of new PH specific treatment due to worsening Pulmonary Hypertension. • Persistent decrease in 6MWD due to worsening pulmonary hypertension • Persistent worsening of functional class due to deterioration of Pulmonary Hypertension.	up to 8 years