|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
22 April 2024 |
|
Main ID: |
NCT02117791 |
|
Date of registration:
|
16/04/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )
JPMS-CTEPH |
|
Scientific title:
|
Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH) |
|
Date of first enrolment:
|
July 16, 2014 |
|
Target sample size:
|
1298 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT02117791 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Bayer Study Director |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Bayer |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients who are treated with Riociguat for CTEPH
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Hypertension, Pulmonary
|
|
Intervention(s)
|
|
Drug: Riociguat (ADEMPAS, BAY63-2521)
|
|
Primary Outcome(s)
|
|
Number of participants with treatment emergent adverse events and adverse drug reactions
[Time Frame: up to 8 years]
|
|
Secondary Outcome(s)
|
|
Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months
[Time Frame: baseline and 4 months, and 12 months]
|
|
Change from baseline in BNP/NT-pro BNP after 4 and 12 months
[Time Frame: baseline and 4 months, and 12 months]
|
|
Time to Clinical Worsening
[Time Frame: up to 8 years]
|
|
Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months
[Time Frame: baseline and 4 months, and 12 months]
|
|
Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months
[Time Frame: baseline and 4 months, and 12 months]
|
|
Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months
[Time Frame: baseline and 4 months, and 12 months]
|
|
Secondary ID(s)
|
|
ADEMPAS-CTEPH
|
|
16843
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|