Hypertension, PulmonaryJPMS-CTEPHNCT02117791
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )
An observational study of Hypertension, Pulmonary, run by Bayer at 1 site in Japan.
Trial summary
This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). 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
- 1,298 participants
- Where
- 1 siteJapan
- Study dates
- 16 Jul 2014to 20 Sep 2023
- 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: Study population includes patients treated with Riociguat for inoperable CTEPH/ persistent or recurrent CTEPH after surgical treatment. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Riociguat for CTEPH need to be registered in principle, until the target number of patients reached.
Who may be able to join
- Patients who are treated with Riociguat for CTEPH
Who cannot join
- Patients who are contraindicated based on the product label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH)
This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Riociguat (ADEMPAS, BAY63-2521)
- Keywords
- Riociguat, Adempas, sGC stimulator, CTEPH, Japan, PMS
- 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 treatment of Riociguat should comply with the local product information (start dose: 3 mg/day, maximum dose: 7.5 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Riociguat treatment group 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 participants with treatment emergent adverse events and adverse drug reactions
Measured: up to 8 years
Secondary outcomes (6)
Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months
Measured: baseline and 4 months, and 12 months
Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months
Measured: baseline and 4 months, and 12 months
Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months
Measured: baseline and 4 months, and 12 months
Change from baseline in BNP/NT-pro BNP after 4 and 12 months
Measured: baseline and 4 months, and 12 months
Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months
Measured: baseline and 4 months, and 12 months
Time to Clinical Worsening
The first occurrence of the following events is recorded and will be considered for the calculation of the combined endpoint: • Death (all-cause mortality) • Heart/lung transplantation • Rescue Pulmonary Endarterectomy, Rescue Balloon Pulmonary Angioplasty or Hospitalization due to persistent worsening of Pulmonary Hypertension • Start of new PH specific treatment due to worsening Pulmonary Hypertension. • Persistent decrease in 6MWD due to worsening pulmonary hypertension • Persistent worsening of functional class due to deterioration of Pulmonary Hypertension.
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study start16 Jul 2014
- Primary completion3 Apr 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,298 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
- NCT02117791
- Sponsor's protocol ID
- 16843
- Other IDs
- ADEMPAS-CTEPH
- Acronym
- JPMS-CTEPH
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2014
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Publications
Tanabe N, Ogo T, Hatano M, Kigawa A, Sunaya T, Sato S. Safety and effectiveness of riociguat for chronic thromboembolic pulmonary hypertension in real-world clinical practice: interim data from post-marketing surveillance in Japan. Pulm Circ. 2020 Jul 23;10(3):2045894020938986. doi: 10.1177/2045894020938986. eCollection 2020 Jul-Sep.
PubMed 32754307
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH)
- ClinicalTrials.gov ID
- NCT02117791
- Acronym / sponsor ID
- JPMS-CTEPH / 16843
- Conditions
- Hypertension, Pulmonary
- Keywords
- Riociguat, Adempas, sGC stimulator, CTEPH, Japan, PMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,298 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2014 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 21 Apr 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.
This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Riociguat (ADEMPAS, BAY63-2521)Riociguat treatment group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population includes patients treated with Riociguat for inoperable CTEPH/ persistent or recurrent CTEPH after surgical treatment. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Riociguat for CTEPH need to be registered in principle, until the target number of patients reached.
Key inclusion criteria (1 listed)
- Patients who are treated with Riociguat for CTEPH
Key exclusion criteria (1 listed)
- Patients who are contraindicated based on the product label
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 treatment of Riociguat should comply with the local product information (start dose: 3 mg/day, maximum dose: 7.5 mg/day) | Drug | Group 1 |
Primary outcome
Number of participants with treatment emergent adverse events and adverse drug reactions
Time frame: up to 8 years
6 secondary outcomes
Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months
Time frame: baseline and 4 months, and 12 months
Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months
Time frame: baseline and 4 months, and 12 months
Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months
Time frame: baseline and 4 months, and 12 months
Change from baseline in BNP/NT-pro BNP after 4 and 12 months
Time frame: baseline and 4 months, and 12 months
Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months
Time frame: baseline and 4 months, and 12 months
Time to Clinical Worsening
Time frame: up to 8 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 11 Apr 2024.
- Derived from this study: PubMed 32754307Tanabe N, Ogo T, Hatano M, Kigawa A, Sunaya T, Sato S. Safety and effectiveness of riociguat for chronic thromboembolic pulmonary hypertension in real-world clinical practice: interim data from post-marketing surveillance in Japan. Pulm Circ. 2020 Jul 23;10(3):2045894020938986. doi: 10.1177/2045894020938986. eCollection 2020 Jul-Sep.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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
1 site in 1 country: 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 1 site in Japan.
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 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 participants with treatment emergent adverse events and adverse drug reactions (time frame: up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02117791, which also lists 1 linked publication.
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 11 Apr 2024.