Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02092818




Registration number
NCT02092818
Ethics application status
Date submitted
19/03/2014
Date registered
20/03/2014
Date last updated
19/06/2019

Titles & IDs
Public title
EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
Scientific title
EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
Secondary ID [1] 0 0
AD1301
Secondary ID [2] 0 0
16657
Universal Trial Number (UTN)
Trial acronym
EXPERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Riociguat (Adempas, BAY63-2521)

Group 1 - Patients who have been prescribed Adempas for a medically appropriate use


Treatment: Drugs: 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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of adverse events
Timepoint [1] 0 0
Up to 4 years
Primary outcome [2] 0 0
Number of serious adverse events
Timepoint [2] 0 0
Up to 4 years
Primary outcome [3] 0 0
All-cause mortality
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH)
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Incidence of AE of special interest overall
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Incidence of AE of special interest in different PH indications (PAH, CTEPH)
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
6 minute walking distance
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Functional class of pulmonary hypertension according to NYHA/ WHO
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Borg Dyspnoea Index
Timepoint [7] 0 0
Up to 4 years
Secondary outcome [8] 0 0
EQ5D visual analogue scale (VAS) score
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
Number of patients with hemodynamic measurements
Timepoint [9] 0 0
Up to 4 years
Secondary outcome [10] 0 0
Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP))
Timepoint [10] 0 0
Up to 4 years
Secondary outcome [11] 0 0
Number of hospitalization
Timepoint [11] 0 0
Up to 4 years
Secondary outcome [12] 0 0
Number of outpatient visits
Timepoint [12] 0 0
Up to 4 years
Secondary outcome [13] 0 0
Number of days in home care
Timepoint [13] 0 0
Up to 4 years
Secondary outcome [14] 0 0
Number of days in rehabilitation
Timepoint [14] 0 0
Up to 4 years
Secondary outcome [15] 0 0
Number of days in nursery home
Timepoint [15] 0 0
Up to 4 years
Secondary outcome [16] 0 0
Drug treatment for PH
Timepoint [16] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
- Female and male patients who start or are on treatment with Adempas

- Written informed consent
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients currently participating in an interventional clinical trial

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2018
Sample size
Target
Accrual to date
Final
1316
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Multiple Locations
Recruitment postcode(s) [1] 0 0
- Multiple Locations
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Multiple Locations
Country [2] 0 0
Austria
State/province [2] 0 0
Multiple Locations
Country [3] 0 0
Belgium
State/province [3] 0 0
Multiple Locations
Country [4] 0 0
Canada
State/province [4] 0 0
Multiple Locations
Country [5] 0 0
Colombia
State/province [5] 0 0
Multiple Locations
Country [6] 0 0
Czechia
State/province [6] 0 0
Multiple Locations
Country [7] 0 0
Denmark
State/province [7] 0 0
Multiple Locations
Country [8] 0 0
Estonia
State/province [8] 0 0
Multiple Locations
Country [9] 0 0
Finland
State/province [9] 0 0
Multiple Locations
Country [10] 0 0
France
State/province [10] 0 0
Multiple Locations
Country [11] 0 0
Germany
State/province [11] 0 0
Multiple Locations
Country [12] 0 0
Greece
State/province [12] 0 0
Multiple Locations
Country [13] 0 0
Ireland
State/province [13] 0 0
Multiple Locations
Country [14] 0 0
Italy
State/province [14] 0 0
Multiple Locations
Country [15] 0 0
Luxembourg
State/province [15] 0 0
Multiple Locations
Country [16] 0 0
Netherlands
State/province [16] 0 0
Multiple Locations
Country [17] 0 0
Norway
State/province [17] 0 0
Multiple Locations
Country [18] 0 0
Portugal
State/province [18] 0 0
Multiple Locations
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Multiple Locations
Country [20] 0 0
Saudi Arabia
State/province [20] 0 0
Multiple Locations
Country [21] 0 0
Slovakia
State/province [21] 0 0
Multiple Locations
Country [22] 0 0
Spain
State/province [22] 0 0
Multiple Locations
Country [23] 0 0
Sweden
State/province [23] 0 0
Multiple Locations
Country [24] 0 0
Switzerland
State/province [24] 0 0
Multiple Locations
Country [25] 0 0
Taiwan
State/province [25] 0 0
Multiple Locations
Country [26] 0 0
Turkey
State/province [26] 0 0
Multiple Locations
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Multiple Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02092818
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02092818