COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02428985
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : September 18, 2020
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Hypertension, Pulmonary Drug: Riociguat (ADEMPAS, BAY63-2521)

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH)
Actual Study Start Date : June 29, 2015
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : January 16, 2024

Group/Cohort Intervention/treatment
Riociguat treatment group
Drug: Riociguat (ADEMPAS, BAY63-2521)
The treatment of Riociguat should comply with the local product information

Primary Outcome Measures :
  1. Number of participants with treatment emergent adverse events. Adverse events of special interest:Hypotension,Gastrointestinal disorder,Hemoptysis, pulmonary hemorrhage and Pulmonary congestion, pulmonary edema [ Time Frame: Up to 7 years ]
  2. Number of participants with adverse drug reaction [ Time Frame: Up to 7 years ]

Secondary Outcome Measures :
  1. Change from baseline in 6-Minute Walking Distance at 3 months and 12 months [ Time Frame: Baseline and 3 months,Baseline and 12 months ]
  2. Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months [ Time Frame: Baseline and 3 months,Baseline and 12 months ]
  3. Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months [ Time Frame: Baseline and 3 months,Baseline and 12 months ]
  4. 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. [ Time Frame: Baseline and 3 months,Baseline and 12 months ]
  5. Change from baseline in WHO functional class after 3 and 12 months [ Time Frame: Baseline and 3 months,Baseline and 12 months ]
  6. Time to Clinical Worsening [ Time Frame: Up to 7 years ]
    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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • Patients who are treated with Riociguat for PAH

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02428985

Layout table for location contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937

Layout table for location information
Many Locations Recruiting
Multiple Locations, Japan
Sponsors and Collaborators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Layout table for additonal information
Responsible Party: Bayer Identifier: NCT02428985    
Other Study ID Numbers: 17519
AD1510JP ( Other Identifier: Company Internal )
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
soluble guanylate cyclase (sGC) stimulator
Pulmonary arterial hypertension
Post-marketing surveillance
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Enzyme Activators
Molecular Mechanisms of Pharmacological Action