Hypertension, PulmonaryEXPERTNCT02092818
EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
An observational study of Hypertension, Pulmonary, run by Bayer at 28 sites in 28 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Riociguat (Adempas, BAY63-2521)
- How many people
- 1,316 participants
- Where
- 28 sitesin 28 countries
- Study dates
- 31 May 2014to 29 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have been prescribed Adempas® for a medically appropriate use
Who may be able to join
- Female and male patients who start or are on treatment with Adempas
- Written informed consent
Who cannot join
- Patients currently participating in an interventional clinical trial
Trial locations and contacts
28 sites in 28 countries.
28 sites in 28 countries
About this study
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.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Riociguat (Adempas, BAY63-2521)
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (Adempas, BAY63-2521)Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients who have been prescribed Adempas for a medically appropriate use Receives: Drug: Riociguat (Adempas, BAY63-2521) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: Up to 4 years
Number of serious adverse events
Measured: Up to 4 years
All-cause mortality
Measured: Up to 4 years
Secondary outcomes (16)
Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH)
Measured: Up to 4 years
Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)
Measured: Up to 4 years
Incidence of AE of special interest overall
Measured: Up to 4 years
Incidence of AE of special interest in different PH indications (PAH, CTEPH)
Measured: Up to 4 years
6 minute walking distance
Measured: Up to 4 years
Functional class of pulmonary hypertension according to NYHA/ WHO
NYHA/ WHO: New York Heart Association / World Health Organization
Measured: Up to 4 years
Borg Dyspnoea Index
Measured: Up to 4 years
EQ5D visual analogue scale (VAS) score
EQ5D: EurQuol 5 dimensions (questionnaire)
Measured: Up to 4 years
Number of patients with hemodynamic measurements
Measured: Up to 4 years
Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP))
Measured: Up to 4 years
Number of hospitalization
Measured: Up to 4 years
Number of outpatient visits
Measured: Up to 4 years
Number of days in home care
Measured: Up to 4 years
Number of days in rehabilitation
Measured: Up to 4 years
Number of days in nursery home
Measured: Up to 4 years
Drug treatment for PH
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study start31 May 2014
- Primary completion31 Mar 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092818
- Sponsor's protocol ID
- 16657
- Other IDs
- AD1301
- Acronym
- EXPERT
- Status last verified
- Jun 2019
- First submitted
- 19 Mar 2014
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02092818
- Acronym / sponsor ID
- EXPERT / 16657
- Conditions
- Hypertension, Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,316 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 May 2014 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Riociguat (Adempas, BAY63-2521)Patients who have been prescribed Adempas for a medically appropriate use |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have been prescribed Adempas® for a medically appropriate use
Key inclusion criteria (2 listed)
- Female and male patients who start or are on treatment with Adempas
- Written informed consent
Key exclusion criteria (1 listed)
- Patients currently participating in an interventional clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Group 1 |
Primary outcome
Number of adverse events
Time frame: Up to 4 years
Number of serious adverse events
Time frame: Up to 4 years
All-cause mortality
Time frame: Up to 4 years
16 secondary outcomes
Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH)
Time frame: Up to 4 years
Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)
Time frame: Up to 4 years
Incidence of AE of special interest overall
Time frame: Up to 4 years
Incidence of AE of special interest in different PH indications (PAH, CTEPH)
Time frame: Up to 4 years
6 minute walking distance
Time frame: Up to 4 years
Functional class of pulmonary hypertension according to NYHA/ WHO
Time frame: Up to 4 years
Borg Dyspnoea Index
Time frame: Up to 4 years
EQ5D visual analogue scale (VAS) score
Time frame: Up to 4 years
Number of patients with hemodynamic measurements
Time frame: Up to 4 years
Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP))
Time frame: Up to 4 years
Number of hospitalization
Time frame: Up to 4 years
Number of outpatient visits
Time frame: Up to 4 years
Number of days in home care
Time frame: Up to 4 years
Number of days in rehabilitation
Time frame: Up to 4 years
Number of days in nursery home
Time frame: Up to 4 years
Drug treatment for PH
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
28 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary, run by Bayer at 28 sites in 28 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Argentina, Australia, Austria, Belgium, Canada and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.