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NCT02092818 Clinical Trial

EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

Hypertension, Pulmonary Clinical Trial

— EXPERT  

Official title:
EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02092818
Other study ID # 16657
Secondary ID AD1301
Status Completed
Phase
First received
Last updated
Start date May 31, 2014
Est. completion date June 29, 2018

Study information
Verified date June 2019
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1316
Est. completion date June 29, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Canada,  Colombia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Ireland,  Italy,  Luxembourg,  Netherlands,  Norway,  Portugal,  Russian Federation,  Saudi Arabia,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

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