Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH)

NCT02428985 | Completed

• 2 other identifiers: 17519AD1510JP
• Study Type: observational
• Target: 882
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective in this study is to collect post-marketing information on Riociguat safety.Thus, the information on adverse events (AEs) and adverse drug reactions (ADRs) that occur within the first 12 months and in the following 6 -year observation at most, after starting Riociguat treatment under the routine clinical practice will be collected. The secondary objectives are collecting information on Riociguat effectiveness, such as 6-Minute Walking Distance (6MWD) Test. Since it is assumed that Riociguat is for long-term use, information on Pulmonary Arterial Hypertension (PAH) clinical worsening will also be surveyed once a year.

Conditions

Hypertension, Pulmonary

Keywords

Riociguat; Adempas; soluble guanylate cyclase (sGC) stimulator; Pulmonary arterial hypertension; Japan; Post-marketing surveillance

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment emergent adverse events. Adverse events of special interest:Hypotension,Gastrointestinal disorder,Hemoptysis, pulmonary hemorrhage and Pulmonary congestion, pulmonary edema

  Up to 7 years

• Number of participants with adverse drug reaction

  Up to 7 years

Secondary Outcomes (6)

• Change from baseline in 6-Minute Walking Distance at 3 months and 12 months

  Baseline and 3 months,Baseline and 12 months

• Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months

  Baseline and 3 months,Baseline and 12 months

• Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months

  Baseline and 3 months,Baseline and 12 months

• Change in blood concentration from baseline in brain natriuretic peptide / N-terminal pro-brain natriuretic peptide (BPN/NT-pro BNP) after 3 and 12 months.

  Baseline and 3 months,Baseline and 12 months

• Change from baseline in WHO functional class after 3 and 12 months

  Baseline and 3 months,Baseline and 12 months

Study Arms (1)

Riociguat

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

Riociguat

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 PAH. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Riociguat for PAH need to be registered in principle, until the target number of patients reached.

You may qualify if:

• Patients who are treated with Riociguat for PAH

You may not qualify if:

• N/A

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Limb-girdle muscular dystrophy, type 2E; Pulmonary Arterial Hypertension

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 21, 2015
• First Posted: April 29, 2015
• Study Start: June 29, 2015
• Primary Completion: April 17, 2023
• Study Completion: September 20, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)