Hypertension, PulmonaryCAPTURENCT02545465
A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice
An observational study of Hypertension, Pulmonary, run by Bayer at 7 sites in 7 countries.
Trial summary
The aim of this study is to understand the treatment patterns in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a switch of treatment to Adempas in real-life clinical practice. 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
- 125 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 15 Sep 2015to 31 Aug 2016
- 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: Source population of the study are patients with Pulmonary arterial hypertension(PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH). Patients with this rare condition are mostly diagnosed and managed at specialist centers. This includes initiation or any change of Pulmonary Hypertension (PH) therapy. The participation of these specialized centers in the study is going to ensure the representativeness of the study population. In order to reduce selection bias physicians will be asked to include all eligible patients.
Who may be able to join
- Female and male adult patients diagnosed with PAH or inoperable/recurrent/persistent CTEPH who have been switched from a PH treatment (i.e. Endothelin Receptor Antagonist(ERAs), Phosphodiesterase-5 inhibitor(PDE5i) or Prostacyclin Analog (PCA) to Adempas
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Patients who have not switched their therapy from an Endothelin Receptor Antagonist (ERA) or Prostacyclin Analog (PCA) but received Adempas purely as an add-on therapy
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas
The aim of this study is to understand the treatment patterns in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a switch of treatment to Adempas in real-life clinical practice.
In addition, this study will describe patient demographics and reason for switching
- Conditions
- Hypertension, Pulmonary
- Being tested
- Riociguat (Adempas, BAY63-2521)
- Keywords
- Pulmonary Arterial Hypertension, Inoperable Chronic Thromboembolic Pulmonary Hypertension, Persistent Chronic Thromboembolic Pulmonary Hypertension, Recurrent Chronic Thromboembolic Pulmonary Hypertension, Switch of therapy, Titration phase, Retrospective chart review
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (Adempas, BAY63-2521)Drug
As per the treating physicians discretion
| Study group | Role | What they receive |
|---|---|---|
| BAY63-2521 | Patients who have been switched from a Pulmonary Hypertension treatment to Adempas Receives: Drug: Riociguat (Adempas, BAY63-2521) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Starting Dose
Measured: Up to a total of 8 weeks of titration period
Dose Increments
Measured: Up to a total of 8 weeks of titration period
Final Dose
Measured: Up to a total of 8 weeks of titration period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study start15 Sep 2015
- Primary completion31 May 2016
- Study completion31 Aug 2016
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
- Retrospective
- Enrolment
- 125 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
- NCT02545465
- Sponsor's protocol ID
- 17983
- Other IDs
- AD1501
- Acronym
- CAPTURE
- Status last verified
- May 2017
- First submitted
- 8 Sep 2015
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas
- ClinicalTrials.gov ID
- NCT02545465
- Acronym / sponsor ID
- CAPTURE / 17983
- Conditions
- Hypertension, Pulmonary
- Keywords
- Pulmonary Arterial Hypertension, Inoperable Chronic Thromboembolic Pulmonary Hypertension, Persistent Chronic Thromboembolic Pulmonary Hypertension, Recurrent Chronic Thromboembolic Pulmonary Hypertension, Switch of therapy, Titration phase, Retrospective chart review
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 10 Sep 2015 (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.
The aim of this study is to understand the treatment patterns in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a switch of treatment to Adempas in real-life clinical practice.
In addition, this study will describe patient demographics and reason for switching
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY63-2521 | – | Drug: Riociguat (Adempas, BAY63-2521)Patients who have been switched from a Pulmonary Hypertension treatment to Adempas |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Source population of the study are patients with Pulmonary arterial hypertension(PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH). Patients with this rare condition are mostly diagnosed and managed at specialist centers. This includes initiation or any change of Pulmonary Hypertension (PH) therapy. The participation of these specialized centers in the study is going to ensure the representativeness of the study population. In order to reduce selection bias physicians will be asked to include all eligible patients.
Key inclusion criteria (1 listed)
- Female and male adult patients diagnosed with PAH or inoperable/recurrent/persistent CTEPH who have been switched from a PH treatment (i.e. Endothelin Receptor Antagonist(ERAs), Phosphodiesterase-5 inhibitor(PDE5i) or Prostacyclin Analog (PCA) to Adempas
Key exclusion criteria (2 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Patients who have not switched their therapy from an Endothelin Receptor Antagonist (ERA) or Prostacyclin Analog (PCA) but received Adempas purely as an add-on therapy
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)As per the treating physicians discretion | Drug | BAY63-2521 |
Primary outcome
Starting Dose
Time frame: Up to a total of 8 weeks of titration period
Dose Increments
Time frame: Up to a total of 8 weeks of titration period
Final Dose
Time frame: Up to a total of 8 weeks of titration period
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 24 May 2017.
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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
7 sites in 7 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 7 sites in 7 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 1 inclusion and 2 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, Canada, Colombia, Germany, Japan and 2 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?
Starting Dose (time frame: Up to a total of 8 weeks of titration period). 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 24 May 2017.