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Clinical Trials/NCT02092818
NCT02092818CompletedNot Applicable

EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

Bayer0 sites1,316 target enrollmentStarted: May 31, 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Bayer
Enrollment
1,316
Primary Endpoint
All-cause mortality
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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) (Drug)

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)

Investigators

Sponsor
Bayer
Sponsor Class
Industry
Responsible Party
Sponsor

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