CAPTURE: 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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02545465
• Collaborator: (none)
• Enrollment: 125
• Locations: 7
• Actual Duration (Months): 11.5
• Patients Per Site: 17.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Pulmonary	Drug: Riociguat (Adempas, BAY63-2521)

Study Design

• Study Type: Observational
• Actual Enrollment: 125 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas
• Actual Study Start Date: Sep 15, 2015
• Actual Primary Completion Date: May 31, 2016
• Actual Study Completion Date: Aug 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
BAY63-2521 Patients who have been switched from a Pulmonary Hypertension treatment to Adempas	Drug: Riociguat (Adempas, BAY63-2521); As per the treating physicians discretion

Outcome Measures

Primary Outcome Measures

1. Starting Dose [Up to a total of 8 weeks of titration period]

2. Dose Increments [Up to a total of 8 weeks of titration period]

3. Final Dose [Up to a total of 8 weeks of titration period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Belgium
2		Many Locations		Canada
3		Many Locations		Colombia
4		Many Locations		Germany
5		Many Locations		Japan
6		Many Locations		Sweden
7		Many Locations		Turkey

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02545465
• Other Study ID Numbers: 17983; AD1501
• First Posted: Sep 10, 2015
• Last Update Posted: May 24, 2017
• Last Verified: May 1, 2017

• Keywords provided by Bayer: Pulmonary Arterial Hypertension; Inoperable Chronic Thromboembolic Pulmonary Hypertension; Persistent Chronic Thromboembolic Pulmonary Hypertension; Recurrent Chronic Thromboembolic Pulmonary Hypertension; Switch of therapy; Titration phase; Retrospective chart review
• Additional relevant MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Riociguat

Study Results

No Results Posted as of May 24, 2017