Clinical trial NCT02428985: Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH)
Official title: Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Riociguat
Adempas
soluble guanylate cyclase (sGC) stimulator
Pulmonary arterial hypertension
Japan
Post-marketing surveillance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 882
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for PAH. A total of 600 patients (valid for safety analysis) is planned to be included in 4 years. This study is performed as an "all-case investigation" therefore; all patients who receive Riociguat treatment for PAH need to be registered, in principle. The treatment should be performed based on the product label in Japan. The standard observation period will last for 12 months from starting Riociguat treatment. Safety and effectiveness will be evaluated at the 3rd and 12th month of treatment. In addition, the extension observation period will be carried out as long as Riociguat treatment continues or at most for more 6 years. The purpose is to collect information on safety and effectiveness, such as adverse events and clinical worsening of PAH, once a year. Combining the standard observation and the extension observation period the patient could be followed for at most 7 years. When Riociguat treatment is terminated, the observation of the patient ends. The investigator should record data for each patient, as defined in the protocol, using the Electronic Data Capture (EDC) system. The duration of the study is of approximately 8 years from PAH indication approval.

Eligibility criteria: Inclusion Criteria:

* Patients who are treated with Riociguat for PAH

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of participants with treatment emergent adverse events. Adverse events of special interest:Hypotension,Gastrointestinal disorder,Hemoptysis, pulmonary hemorrhage and Pulmonary congestion, pulmonary edema
timeFrame: Up to 7 years
measure: Number of participants with adverse drug reaction
timeFrame: Up to 7 years
Secondary outcomes:
measure: Change from baseline in 6-Minute Walking Distance at 3 months and 12 months
timeFrame: Baseline and 3 months,Baseline and 12 months
measure: Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months
timeFrame: Baseline and 3 months,Baseline and 12 months
measure: Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months
timeFrame: Baseline and 3 months,Baseline and 12 months
measure: 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
measure: Change from baseline in WHO functional class after 3 and 12 months
timeFrame: Baseline and 3 months,Baseline and 12 months
measure: Time to Clinical Worsening
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: