EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension (EXPERT)

June 18, 2019 updated by: Bayer
In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1316

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who have been prescribed Adempas® for a medically appropriate use

Description

Inclusion Criteria:

  • Female and male patients who start or are on treatment with Adempas
  • Written informed consent

Exclusion Criteria:

  • Patients currently participating in an interventional clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients who have been prescribed Adempas for a medically appropriate use
Drug: Riociguat (Adempas, BAY63-2521)
The decision on clinical management of the patient including the actual treatment duration will be determined solely by the physician not by the clinical study protocol (CSP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: Up to 4 years
Up to 4 years
Number of serious adverse events
Time Frame: Up to 4 years
Up to 4 years
All-cause mortality
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH)
Time Frame: Up to 4 years
Up to 4 years
Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)
Time Frame: Up to 4 years
Up to 4 years
Incidence of AE of special interest overall
Time Frame: Up to 4 years
Up to 4 years
Incidence of AE of special interest in different PH indications (PAH, CTEPH)
Time Frame: Up to 4 years
Up to 4 years
6 minute walking distance
Time Frame: Up to 4 years
Up to 4 years
Functional class of pulmonary hypertension according to NYHA/ WHO
Time Frame: Up to 4 years
NYHA/ WHO: New York Heart Association / World Health Organization
Up to 4 years
Borg Dyspnoea Index
Time Frame: Up to 4 years
Up to 4 years
EQ5D visual analogue scale (VAS) score
Time Frame: Up to 4 years
EQ5D: EurQuol 5 dimensions (questionnaire)
Up to 4 years
Number of patients with hemodynamic measurements
Time Frame: Up to 4 years
Up to 4 years
Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP))
Time Frame: Up to 4 years
Up to 4 years
Number of hospitalization
Time Frame: Up to 4 years
Up to 4 years
Number of outpatient visits
Time Frame: Up to 4 years
Up to 4 years
Number of days in home care
Time Frame: Up to 4 years
Up to 4 years
Number of days in rehabilitation
Time Frame: Up to 4 years
Up to 4 years
Number of days in nursery home
Time Frame: Up to 4 years
Up to 4 years
Drug treatment for PH
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 31, 2014

Primary Completion (ACTUAL)

March 31, 2018

Study Completion (ACTUAL)

June 29, 2018

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (ESTIMATE)

March 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16657
  • AD1301 (OTHER: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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