Trial Condition(s):
Hypertension, Pulmonary
Prospective, non-interventional, multi-center post-authorization safety study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH ) (JPMS-CTEPH)
Bayer Identifier:
16843
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Patients who are treated with Riociguat for CTEPH
Exclusion Criteria
- Patients who are contraindicated based on the product label
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants with treatment emergent adverse events and adverse drug reactionsTimeframe: up to 8 years
Secondary Outcome
- Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 monthsTimeframe: baseline and 4 months, and 12 months
- Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 monthsTimeframe: baseline and 4 months, and 12 months
- Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 monthsTimeframe: baseline and 4 months, and 12 months
- Change from baseline in BNP/NT-pro BNP after 4 and 12 monthsTimeframe: baseline and 4 months, and 12 months
- Change from baseline in WHO (World Health Organization) functional class after 4 and 12 monthsTimeframe: baseline and 4 months, and 12 months
- Time to Clinical WorseningThe 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.Timeframe: up to 8 years
Additional Information
Not Available
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