A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02545465
• Date of registration: 08/09/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice CAPTURE
• Scientific title: Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas
• Date of first enrolment: September 15, 2015
• Target sample size: 125
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02545465
• Study type: Observational
• Phase: N/A

Countries of recruitment

Belgium, Canada, Colombia, Denmark, Germany, Japan, Sweden, Turkey, United Kingdom

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female and male adult patients diagnosed with PAH or inoperable/recurrent/persistent
CTEPH who have been switched from a PH treatment (i.e. Endothelin Receptor
Antagonist(ERAs), Phosphodiesterase-5 inhibitor(PDE5i) or Prostacyclin Analog (PCA) to
Adempas

Exclusion Criteria:

- Patients participating in an investigational program with interventions outside of
routine clinical practice

- Patients who have not switched their therapy from an Endothelin Receptor Antagonist
(ERA) or Prostacyclin Analog (PCA) but received Adempas purely as an add-on therapy



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)

Dose Increments [Time Frame: Up to a total of 8 weeks of titration period]

Final Dose [Time Frame: Up to a total of 8 weeks of titration period]

Starting Dose [Time Frame: Up to a total of 8 weeks of titration period]

Secondary ID(s)

17983

AD1501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors