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NCT02545465 Clinical Trial

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

Hypertension, Pulmonary Clinical Trial

— CAPTURE  

Official title:
Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02545465
Other study ID # 17983
Secondary ID AD1501
Status Completed
Phase N/A
First received September 8, 2015
Last updated May 23, 2017
Start date September 15, 2015
Est. completion date August 31, 2016

Study information
Verified date May 2017
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date August 31, 2016
Est. primary completion date May 31, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Riociguat (Adempas, BAY63-2521)
As per the treating physicians discretion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Belgium,  Canada,  Colombia,  Germany,  Japan,  Sweden,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Starting Dose Up to a total of 8 weeks of titration period
Primary Dose Increments Up to a total of 8 weeks of titration period
Primary Final Dose Up to a total of 8 weeks of titration period
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