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

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Riociguat (ADEMPAS, BAY63-2521)

• Registration Number: NCT02117791
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Study Start: 2014-07-16
• Primary Completion: 2023-04-03
• Study Completion: 2023-09-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1298

Inclusion Criteria

• Patients who are treated with Riociguat for CTEPH

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Exclusion Criteria

• Patients who are contraindicated based on the product label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Riociguat (ADEMPAS, BAY63-2521)	Riociguat treatment group

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events and adverse drug reactions	up to 8 years

Secondary Outcome Measures

Name	Time	Method
Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months	baseline and 4 months, and 12 months
Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months	baseline and 4 months, and 12 months
Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months	baseline and 4 months, and 12 months
Change from baseline in BNP/NT-pro BNP after 4 and 12 months	baseline and 4 months, and 12 months
Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months	baseline and 4 months, and 12 months
Time to Clinical Worsening	up to 8 years	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.