Pulmonary HypertensionPhase 3CHEST-2NCT00910429
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
A Phase 3 study testing Riociguat (Adempas, BAY63-2521) in people with Pulmonary Hypertension, run by Bayer at 73 sites in 26 countries.
Trial summary
Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Riociguat (Adempas, BAY63-2521)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 73 sitesin 26 countries
- Study dates
- 1 Jul 2009to 19 Aug 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1
Who cannot join
- Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial
Trial locations and contacts
73 sites in 26 countries.
73 sites in 26 countries
Japan11 sites
Study site
Bunkyo-ku, Tokyo, 113-8655
Study site
Chiba, 260-8677
Study site
Fujisawa, Kanagawa, 251-0041
Study site
Fukuoka, 812-8582
Study site
Kawasaki, Kanagawa, 216-8511
Study site
Kitakyushu, Fukuoka, 802-8555
Study site
Komatsu, Ishikawa-ken, 923-8560
Study site
Nagoya, Aichi-ken, 467-8602
Study site
Sendai, Miyagi, 980-8574
Study site
Shinjuku-ku, Tokyo, 162-8655
Study site
Suwa, Nagano, 392-8510
Germany10 sites
Study site
Cologne, North Rhine-Westphalia, 50924
Study site
Dresden, Saxony, 01307
Study site
Giessen, Hesse, 35392
Study site
Hamburg, 20251
Study site
Hanover, Lower Saxony, 30625
Study site
Heidelberg, Baden-Wurttemberg, 69126
Study site
Homburg, Saarland, 66421
Study site
Leipzig, Saxony, 04103
Study site
München, Bavaria, 81377
Study site
Würzburg, Bavaria, 97074
United States8 sites
Study site
Baltimore, Maryland, 21205
Study site
Boston, Massachusetts, 02118
Study site
Cleveland, Ohio, 44195
Study site
Columbus, Ohio, 43221
Study site
Dallas, Texas, 75390
Study site
Iowa City, Iowa, 52242
Study site
La Jolla, California, 92093
Study site
Sacramento, California, 95817
Canada5 sites
Study site
Calgary, Alberta, T1Y 6J4
Study site
London, Ontario, N6A 4G5
Study site
Montreal, Quebec, H3T 1E2
Study site
Ottawa, Ontario, K1Y 4W7
Study site
Toronto, Ontario, M5G 2N2
France4 sites
Study site
Brest, F-29609
Study site
Le Kremlin-Bicêtre, 94275
Study site
Rouen, 76031
Study site
Vandœuvre-lès-Nancy, 54511
Brazil3 sites
Study site
Porto Alegre, Rio Grande do Sul, 90020 090
Study site
Rio de Janeiro, 21941-913
Study site
São Paulo, São Paulo, 04020-050
China3 sites
Study site
Beijing, 100020
Study site
Beijing, 100037
Study site
Shanghai, 200433
Mexico3 sites
Study site
Mexico City, 14080
Study site
Monterrey, Nuevo León, 64718
Study site
Querétaro, 38000
Turkey (Türkiye)3 sites
Study site
Ankara
Study site
Istanbul, 34093
Study site
Izmir, 35040
Portugal2 sites
Study site
Coimbra, 3000-075
Centro Hospitalar de Lisboa Norte - Hospital Santa Maria
Lisbon, 1649-035
Russia2 sites
Study site
Novosibirsk, 630055
Study site
Saint Petersburg, 197341
United Kingdom2 sites
Study site
Cambridge, Cambridgeshire, CB23 3RE
Study site
Glasgow, West Dunbartonshire, G81 4DY
About this study
Official title: Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.
- Conditions
- Pulmonary Hypertension
- Being tested
- Riociguat (Adempas, BAY63-2521)
- Keywords
- Chronic thromboembolic Hypertension, PH, soluble Guanylate Cyclase Stimulator, sGC
- 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
BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described 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 (TEAE)
Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.
Measured: From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years
Number of Participants With Death
Analyses of deaths were based on the assessment of causal relationship to study medication. The safety follow-up visit was to be performed 30 days after the last dose of riociguat.
Measured: From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit)
Secondary outcomes (6)
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation
Frequency of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Measured: From baseline to Termination visit, up to 10 years
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation
Frequency of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Measured: From baseline to Termination visit, up to 10 years
Change From Baseline of Hemoglobin in Hematology and Coagulation
Hemoglobin is standard Hematology and coagulation parameter. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Measured: From baseline to Termination visit, up to 10 years
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry
Frequency of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Measured: From baseline to Termination visit, up to 10 years
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry
Frequency of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Measured: From baseline to Termination visit, up to 10 years
Change From Baseline of Urate in Clinical Chemistry
Urate is standard clinical chemistry parameter. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Measured: From baseline to Termination visit, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study start1 Jul 2009
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 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
- NCT00910429
- Sponsor's protocol ID
- 11349
- Other IDs
- 2008-003539-19, 2008
- Acronym
- CHEST-2
- Status last verified
- Nov 2023
- First submitted
- 27 May 2009
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Benza RL, Boucly A, Farber HW, Frost AE, Ghofrani HA, Hoeper MM, Lambelet M, Rahner C, Bansilal S, Nikkho S, Meier C, Sitbon O. Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. J Heart Lung Transplant. 2022 Mar;41(3):411-420. doi: 10.1016/j.healun.2021.10.013. Epub 2021 Oct 28.
PubMed 34848133Benza RL, Farber HW, Frost AE, Ghofrani HA, Corris PA, Lambelet M, Nikkho S, Meier C, Hoeper MM. Application of the REVEAL risk score calculator 2.0 in the CHEST study. Respir Med. 2022 Apr-May;195:106783. doi: 10.1016/j.rmed.2022.106783. Epub 2022 Mar 1.
PubMed 35256218Benza RL, Ghofrani HA, Grunig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.
PubMed 34353714Saleh S, Becker C, Frey R, Muck W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.
PubMed 27162632Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.
PubMed 27067478Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.
PubMed 23883377
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
- ClinicalTrials.gov ID
- NCT00910429
- Acronym / sponsor ID
- CHEST-2 / 11349
- Conditions
- Pulmonary Hypertension
- Keywords
- Chronic thromboembolic Hypertension, PH, soluble Guanylate Cyclase Stimulator, sGC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 29 May 2009 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Riociguat (Adempas, BAY63-2521) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1
Key exclusion criteria (1 listed)
- Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension 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)BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study | Drug | Arm 1 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Time frame: From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years
Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.
Number of Participants With Death
Time frame: From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit)
Analyses of deaths were based on the assessment of causal relationship to study medication. The safety follow-up visit was to be performed 30 days after the last dose of riociguat.
6 secondary outcomes
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation
Time frame: From baseline to Termination visit, up to 10 years
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation
Time frame: From baseline to Termination visit, up to 10 years
Change From Baseline of Hemoglobin in Hematology and Coagulation
Time frame: From baseline to Termination visit, up to 10 years
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry
Time frame: From baseline to Termination visit, up to 10 years
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry
Time frame: From baseline to Termination visit, up to 10 years
Change From Baseline of Urate in Clinical Chemistry
Time frame: From baseline to Termination visit, up to 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34848133Benza RL, Boucly A, Farber HW, Frost AE, Ghofrani HA, Hoeper MM, Lambelet M, Rahner C, Bansilal S, Nikkho S, Meier C, Sitbon O. Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. J Heart Lung Transplant. 2022 Mar;41(3):411-420. doi: 10.1016/j.healun.2021.10.013. Epub 2021 Oct 28.
- Background: PubMed 35256218Benza RL, Farber HW, Frost AE, Ghofrani HA, Corris PA, Lambelet M, Nikkho S, Meier C, Hoeper MM. Application of the REVEAL risk score calculator 2.0 in the CHEST study. Respir Med. 2022 Apr-May;195:106783. doi: 10.1016/j.rmed.2022.106783. Epub 2022 Mar 1.
- Derived from this study: PubMed 34353714Benza RL, Ghofrani HA, Grunig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.
- Derived from this study: PubMed 27162632Saleh S, Becker C, Frey R, Muck W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.
- Derived from this study: PubMed 27067478Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.
- Derived from this study: PubMed 23883377Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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
73 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Riociguat (Adempas, BAY63-2521) in people with Pulmonary Hypertension, run by Bayer at 73 sites in 26 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 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Japan, Germany, United States, Canada, France and 21 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (TEAE) (time frame: From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years). The study lists 2 primary outcomes in all. 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 NCT00910429, which also lists 6 linked publications.
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 7 Nov 2023.