check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:
17983
ClinicalTrials.gov Identifier:
NCT02545465
EudraCT Number:
Not Available
EU CT Number:
Not Available
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

Trial purpose

The aim of this study is to understand the treatment patterns in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a switch of treatment to Adempas in real-life clinical practice.
In addition, this study will describe patient demographics and reason for switching

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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

  • - 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

Trial summary

Enrollment Goal
125
Trial Dates
September 2015 - August 2016
Phase
N/A
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Withdrawn
Many Locations, United Kingdom
Completed
Many Locations, Japan
Completed
Many Locations, Canada
Completed
Many Locations, Belgium
Completed
Many Locations, Sweden
Withdrawn
Many Locations, Denmark
Completed
Many Locations, Turkey
Completed
Many Locations, Colombia

Primary Outcome

  • Starting Dose
    date_rangeTime Frame:
    Up to a total of 8 weeks of titration period
    enhanced_encryption
    Safety Issue:
    No
  • Dose Increments
    date_rangeTime Frame:
    Up to a total of 8 weeks of titration period
    enhanced_encryption
    Safety Issue:
    No
  • Final Dose
    date_rangeTime Frame:
    Up to a total of 8 weeks of titration period
    enhanced_encryption
    Safety Issue:
    No

Trial design

Retrospective chart review of patients with PAH or inoperable/persistent/recurrent CTEPH who transition their PH treatment to Adempas
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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