Study 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

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

Trial summary

Enrollment Goal

125

Trial Dates

September 2015 - August 2016

Phase

N/A

Could I Receive a placebo

Products

Adempas (Riociguat, BAY63-2521)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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Withdrawn		Many Locations, United Kingdom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Withdrawn		Many Locations, Denmark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
Time Frame:
Up to a total of 8 weeks of titration period
Safety Issue:
No
Dose Increments
Time Frame:
Up to a total of 8 weeks of titration period
Safety Issue:
No
Final Dose
Time Frame:
Up to a total of 8 weeks of titration period
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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