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

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ClinicalTrials.gov Identifier: NCT02428985
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

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
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)



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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.
Criteria

Inclusion Criteria:

  • Patients who are treated with Riociguat for PAH

Exclusion Criteria:


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 ClinicalTrials.gov identifier (NCT number): NCT02428985


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
Japan
Many Locations Recruiting
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02428985     History of Changes
Other Study ID Numbers: 17519
AD1510JP ( Other Identifier: Company Internal )
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Riociguat
Adempas
soluble guanylate cyclase (sGC) stimulator
Pulmonary arterial hypertension
Japan
Post-marketing surveillance

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases