check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

17519

ClinicalTrials.gov Identifier:

NCT02428985

EudraCT Number:

Not Available

EU CT Number:

Not Available
Prospective, non-interventional, multi-center, post-authorization safety study of Riociguat for Pulmonary Arterial Hypertension (PAH)

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients who are treated with Riociguat for PAH

  • - N/A

Trial summary

Enrollment Goal
882
Trial Dates
June 2015 - September 2023
Phase
N/A
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many LocationsMany Locations, Japan

Primary Outcome

  • Number of participants with treatment emergent adverse events. Adverse events of special interest:Hypotension,Gastrointestinal disorder,Hemoptysis, pulmonary hemorrhage and Pulmonary congestion, pulmonary edema
    date_rangeTime Frame:
    Up to 7 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse drug reaction
    date_rangeTime Frame:
    Up to 7 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Change from baseline in 6-Minute Walking Distance at 3 months and 12 months
    date_rangeTime Frame:
    Baseline and 3 months,Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months
    date_rangeTime Frame:
    Baseline and 3 months,Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months
    date_rangeTime Frame:
    Baseline and 3 months,Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Baseline and 3 months,Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in WHO functional class after 3 and 12 months
    date_rangeTime Frame:
    Baseline and 3 months,Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to Clinical Worsening
    The 1st occurrence of the following events is recorded & will considered for the calculation of the combined endpoint : -Death (all-cause mortality)-Heart/lung transplantation -Atrial Septostomy -Hospitalization due to persistent worsening of Pulmonary Hypertension -Start of new PH specific treatment (endothelin receptor antagonists, prostacycline analogues)or modification of a preexisting Prostacycline analogues treatment)due to worsening Pulmonary Hypertension (WPH) -Persistent decrease in 6MWD due to WPH (e.g. more than 15 % from baseline or more than 30% compared to the last measurement)
    date_rangeTime Frame:
    Up to 7 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A