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

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ClinicalTrials.gov Identifier: NCT02117791
Recruitment Status : Recruiting
First Posted : April 21, 2014
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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)

Study Type : Observational
Estimated Enrollment : 420 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 in 6-Minute Walking Distance [ Time Frame: baseline and 4 months, and 12 months ]
  2. 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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02117791


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

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02117791     History of Changes
Other Study ID Numbers: 16843
ADEMPAS-CTEPH ( Other Identifier: company internal )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

Keywords provided by Bayer:
Riociguat, Adempas, sGC stimulator, CTEPH, Japan, PMS

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