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

NCT02545465 | Completed

• 2 other identifiers: 17983AD1501
• Study Type: observational
• Target: 125
• Locations: 7 countries
• Sites: 7

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

Conditions

Hypertension, Pulmonary

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Starting Dose

  Up to a total of 8 weeks of titration period

• Dose Increments

  Up to a total of 8 weeks of titration period

• Final Dose

  Up to a total of 8 weeks of titration period

Study Arms (1)

BAY63-2521

Patients who have been switched from a Pulmonary Hypertension treatment to Adempas

Drug: Riociguat (Adempas, BAY63-2521)

Interventions

Riociguat (Adempas, BAY63-2521) DRUG

As per the treating physicians discretion

BAY63-2521

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (7)

Unknown Facility

Many Locations, Belgium

Location

Unknown Facility

Many Locations, Canada

Location

Unknown Facility

Many Locations, Colombia

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Japan

Location

Unknown Facility

Many Locations, Sweden

Location

Unknown Facility

Many Locations, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

riociguat

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 10, 2015
• Study Start: September 15, 2015
• Primary Completion: May 31, 2016
• Study Completion: August 31, 2016
• Last Updated: May 24, 2017

Record last verified: 2017-05

Locations

CO (1); CA (1); BE (1); DE (1); JP (1); SE (1); TU (1)