Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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