EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

Bayer0 sites1,316 target enrollmentMay 31, 2014

ConditionsHypertension, Pulmonary

InterventionsRiociguat (Adempas, BAY63-2521)

DrugsRiociguat (Adempas, BAY63-2521)

Overview

Phase: Not Applicable
Intervention: Riociguat (Adempas, BAY63-2521)
Conditions: Hypertension, Pulmonary
Sponsor: Bayer
Enrollment: 1316
Primary Endpoint: All-cause mortality
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 31, 2014

End Date

June 29, 2018

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Group 1

Patients who have been prescribed Adempas for a medically appropriate use

Intervention: Riociguat (Adempas, BAY63-2521)

Outcomes

Primary Outcomes

All-cause mortality

Time Frame: Up to 4 years

Number of adverse events

Time Frame: Up to 4 years

Number of serious adverse events

Time Frame: Up to 4 years

Secondary Outcomes

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