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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02545465
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

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
Hypertension, Pulmonary Drug: Riociguat (Adempas, BAY63-2521)

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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 : September 15, 2015
Actual Primary Completion Date : May 31, 2016
Actual Study Completion Date : August 31, 2016


Group/Cohort 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




Primary Outcome Measures :
  1. Starting Dose [ Time Frame: Up to a total of 8 weeks of titration period ]
  2. Dose Increments [ Time Frame: Up to a total of 8 weeks of titration period ]
  3. Final Dose [ Time Frame: Up to a total of 8 weeks of titration period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Source population of the study are patients with Pulmonary arterial hypertension(PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH). Patients with this rare condition are mostly diagnosed and managed at specialist centers. This includes initiation or any change of Pulmonary Hypertension (PH) therapy. The participation of these specialized centers in the study is going to ensure the representativeness of the study population. In order to reduce selection bias physicians will be asked to include all eligible patients.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545465


Locations
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Belgium
Many Locations, Belgium
Canada
Many Locations, Canada
Colombia
Many Locations, Colombia
Germany
Many Locations, Germany
Japan
Many Locations, Japan
Sweden
Many Locations, Sweden
Turkey
Many Locations, Turkey
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02545465    
Other Study ID Numbers: 17983
AD1501 ( Other Identifier: Company Internal )
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 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:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Riociguat
Enzyme Activators
Molecular Mechanisms of Pharmacological Action