Trial Condition(s):
Hypertension, Pulmonary
Prospective, non-interventional, multi-center, post-authorization safety study of Riociguat for Pulmonary Arterial Hypertension (PAH) (JPMS-PAH)
Bayer Identifier:
17519
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patients who are treated with Riociguat for PAH
Exclusion Criteria
- N/A
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many Locations Many Locations, Japan | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
1
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 edemaTimeframe: Up to 7 years
- Number of participants with adverse drug reactionTimeframe: Up to 7 years
Secondary Outcome
- Change from baseline in 6-Minute Walking Distance at 3 months and 12 monthsTimeframe: Baseline and 3 months,Baseline and 12 months
- Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 monthsTimeframe: Baseline and 3 months,Baseline and 12 months
- Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 monthsTimeframe: 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.Timeframe: Baseline and 3 months,Baseline and 12 months
- Change from baseline in WHO functional class after 3 and 12 monthsTimeframe: Baseline and 3 months,Baseline and 12 months
- 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)Timeframe: Up to 7 years
Additional Information
Not Available
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