check_circleStudy Completed
Hypertension, Pulmonary
Bayer Identifier:
17519
ClinicalTrials.gov Identifier:
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.
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
BothAge
NaN - N/ATrial summary
Enrollment Goal
882Trial Dates
June 2015 - September 2023Phase
N/ACould I Receive a placebo
NoProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many Locations | Many 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 edemadate_rangeTime Frame:Up to 7 yearsenhanced_encryptionYesSafety Issue:
- Number of participants with adverse drug reactiondate_rangeTime Frame:Up to 7 yearsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Change from baseline in 6-Minute Walking Distance at 3 months and 12 monthsdate_rangeTime Frame:Baseline and 3 months,Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 monthsdate_rangeTime Frame:Baseline and 3 months,Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 monthsdate_rangeTime Frame:Baseline and 3 months,Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- 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 monthsenhanced_encryptionNoSafety Issue:
- Change from baseline in WHO functional class after 3 and 12 monthsdate_rangeTime Frame:Baseline and 3 months,Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Time to Clinical WorseningThe 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 yearsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A