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Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH ) (JPMS-CTEPH)

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: NCT02117791
Recruitment Status : Recruiting
First Posted : April 21, 2014
Last Update Posted : October 12, 2021
Information provided by (Responsible Party):

Brief Summary:
This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.

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

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Study Type : Observational
Estimated Enrollment : 1298 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH)
Actual Study Start Date : July 16, 2014
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : January 16, 2024

Group/Cohort Intervention/treatment
Group 1
Riociguat treatment group
Drug: Riociguat (ADEMPAS, BAY63-2521)
The treatment of Riociguat should comply with the local product information (start dose: 3 mg/day, maximum dose: 7.5 mg/day)

Primary Outcome Measures :
  1. Number of participants with treatment emergent adverse events and adverse drug reactions [ Time Frame: up to 8 years ]

Secondary Outcome Measures :
  1. Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months [ Time Frame: baseline and 4 months, and 12 months ]
  2. Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months [ Time Frame: baseline and 4 months, and 12 months ]
  3. Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months [ Time Frame: baseline and 4 months, and 12 months ]
  4. Change from baseline in BNP/NT-pro BNP after 4 and 12 months [ Time Frame: baseline and 4 months, and 12 months ]
  5. Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months [ Time Frame: baseline and 4 months, and 12 months ]
  6. Time to Clinical Worsening [ Time Frame: up to 8 years ]
    The first occurrence of the following events is recorded and will be considered for the calculation of the combined endpoint: • Death (all-cause mortality) • Heart/lung transplantation • Rescue Pulmonary Endarterectomy, Rescue Balloon Pulmonary Angioplasty or Hospitalization due to persistent worsening of Pulmonary Hypertension • Start of new PH specific treatment due to worsening Pulmonary Hypertension. • Persistent decrease in 6MWD due to worsening pulmonary hypertension • Persistent worsening of functional class due to deterioration of Pulmonary Hypertension.

Information from the National Library of Medicine

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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 inoperable CTEPH/ persistent or recurrent CTEPH after surgical treatment. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Riociguat for CTEPH need to be registered in principle, until the target number of patients reached.

Inclusion Criteria:

  • Patients who are treated with Riociguat for CTEPH

Exclusion Criteria:

  • Patients who are contraindicated based on the product label

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): NCT02117791

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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937

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Multiple Locations, Japan
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT02117791    
Other Study ID Numbers: 16843
ADEMPAS-CTEPH ( Other Identifier: company internal )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
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.
Keywords provided by Bayer:
Riociguat, Adempas, sGC stimulator, CTEPH, Japan, PMS
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Enzyme Activators
Molecular Mechanisms of Pharmacological Action