Clinical Trial: EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
Brief Summary: In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome:
- Number of adverse events/ serious adverse events [ Time Frame: Up to 4 years ]
- all-cause mortality [ Time Frame: Up to 4 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of adverse event (AE) and serious adverse event(SAE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH) [ Time Frame: Up to 4 years ]
- 6 minute walking test [ Time Frame: Up to 4 years ]
- Number of hospitalization/outpatient visits [ Time Frame: Up to 4 years ]
Original Secondary Outcome:
- Number of adverse event (AE) and serious adverse event(SAE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH) [ Time Frame: Up to 4 years ]
- 6 minute walking tes [ Time Frame: Up to 4 years ]
- Number of hospitalization/outpatient visits [ Time Frame: Up to 4 years ]
Information By: Bayer
Dates:
Date Received: March 19, 2014
Date Started: May 31, 2014
Date Completion: August 1, 2018
Last Updated: May 17, 2017
Last Verified: May 2017