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