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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

Tracking Information
First Submitted Date September 8, 2015
First Posted Date September 10, 2015
Last Update Posted Date May 24, 2017
Actual Study Start Date September 15, 2015
Actual Primary Completion Date May 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2015)
  • Starting Dose [ Time Frame: Up to a total of 8 weeks of titration period ]
  • Dose Increments [ Time Frame: Up to a total of 8 weeks of titration period ]
  • Final Dose [ Time Frame: Up to a total of 8 weeks of titration period ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas
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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hypertension, Pulmonary
Intervention Drug: Riociguat (Adempas, BAY63-2521)
As per the treating physicians discretion
Study Groups/Cohorts BAY63-2521
Patients who have been switched from a Pulmonary Hypertension treatment to Adempas
Intervention: Drug: Riociguat (Adempas, BAY63-2521)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 15, 2016)
125
Original Estimated Enrollment
 (submitted: September 9, 2015)
80
Actual Study Completion Date August 31, 2016
Actual Primary Completion Date May 31, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Canada,   Colombia,   Germany,   Japan,   Sweden,   Turkey
Removed Location Countries Denmark,   United Kingdom
 
Administrative Information
NCT Number NCT02545465
Other Study ID Numbers 17983
AD1501 ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date May 2017