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

NCT02117791 | Completed

• 2 other identifiers: 16843ADEMPAS-CTEPH
• Study Type: observational
• Target: 1,298
• Locations: 1 country
• Sites: 1

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

Keywords

Riociguat, Adempas, sGC stimulator, CTEPH, Japan, PMS

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment emergent adverse events and adverse drug reactions

  up to 8 years

Secondary Outcomes (6)

• 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

Study Arms (1)

Group 1

Riociguat treatment group

Drug: Riociguat (ADEMPAS, BAY63-2521)

Interventions

Riociguat (ADEMPAS, BAY63-2521) DRUG

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

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population includes patients treated with Riociguat for inoperable CTEPH/ persistent or recurrent CTEPH after surgical treatment. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Riociguat for CTEPH need to be registered in principle, until the target number of patients reached.

You may qualify if:

• Patients who are treated with Riociguat for CTEPH

You may not qualify if:

• Patients who are contraindicated based on the product label

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (1)

• 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.

  PMID: 32754307 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

riociguat

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: July 16, 2014
• Primary Completion: April 3, 2023
• Study Completion: September 20, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

JP (1)