Pulmonary HypertensionPhase 3PATENT-1NCT00810693
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
A Phase 3 study testing Riociguat (Adempas, BAY63-2521) in people with Pulmonary Hypertension, run by Bayer at 122 sites in 30 countries.
Trial summary
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH). 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?
- Yes, some participants may receive a placebo
- How many people
- 445 participants
- Where
- 122 sitesin 30 countries
- Study dates
- 17 Dec 2008to 14 May 2012
- 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
- Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
- Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).
Who cannot join
- All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.
Trial locations and contacts
122 sites in 30 countries.
122 sites in 30 countries
United States18 sites
Study site
Aurora, Colorado, 80045
Study site
Boston, Massachusetts, 02111
Study site
Boston, Massachusetts, 02115
Study site
Cincinnati, Ohio, 45219
Study site
Cleveland, Ohio, 44195
Study site
Columbus, Ohio, 43221
Study site
Dallas, Texas, 75390
Study site
El Paso, Texas, 79902
Study site
Fairfield, Ohio, 45014
Study site
Houston, Texas, 77030
Study site
La Jolla, California, 92037
Study site
Los Angeles, California, 90073
Study site
Louisville, Kentucky, 40202
Study site
New York, New York, 10032
Study site
Omaha, Nebraska, 68131
Study site
Providence, Rhode Island, 02903
Study site
Sacramento, California, 95817
Study site
Tucson, Arizona, 85724
Japan15 sites
Study site
Bunkyo-ku, Tokyo, 113-8655
Study site
Hiroshima, 734-8551
Study site
Kanazawa, Ishikawa-ken, 920-8641
Study site
Kobe, Hyōgo, 650-0017
Study site
Mitaka, Tokyo, 181-8611
Study site
Nagoya, Aichi-ken, 467-8602
Study site
Okayama, 701-1192
Study site
Ōta-ku, Tokyo, 143-8541
Study site
Sagamihara, Kanagawa, 252-0375
Study site
Sendai, Miyagi, 980-8574
Study site
Shinjuku-ku, Tokyo, 160-8582
Study site
Tomigusuku, Okinawa, 901-0243
Study site
Toride, Ibaraki, 302-0022
Study site
Tsukuba, Ibaraki, 305-8576
Study site
Yoshida, Fukui, 910-1193
Germany9 sites
Study site
Cologne, North Rhine-Westphalia, 50924
Study site
Dresden, Saxony, 01307
Study site
Giessen, Hesse, 35392
Study site
Greifswald, Mecklenburg-Vorpommern, 17475
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
France8 sites
Study site
Besançon, 25030
Study site
Brest, F-29609
Study site
Grenoble, 38043
Study site
Lille, 59037
Study site
Montpellier, 34059
Study site
Nice, 06200
Study site
Pessac, 33604
Study site
Rouen, 76031
Australia6 sites
Study site
Auchenflower, Queensland, 4066
Study site
Darlinghurst, New South Wales, 2010
Study site
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, Tasmania, 7000
Study site
New Lambton Heights, New South Wales, 2305
Study site
Prahran, Victoria, 3181
Mexico6 sites
Study site
Culiacán, Sinaloa, 80020
Study site
Guadalajara, Jalisco, 44280
Study site
Guadalajara, Jalisco, 44670
Study site
Mexico City, 14080
Study site
Monterrey, Nuevo León, 64020
Study site
Querétaro, 38000
China5 sites
Study site
Beijing, 100020
Study site
Beijing, 100037
Study site
Guangzhou, Guangdong, 510100
Study site
Shanghai, 200032
Study site
Shanghai, 200433
Italy5 sites
Study site
Milan, Lombardy, 20123
Study site
Pavia, Lombardy, 27100
Study site
Rome, Lazio, 00161
Study site
Trieste, Friuli Venezia Giulia, 34149
Study site
Turin, Piedmont, 10043
Brazil4 sites
Study site
Porto Alegre, Rio Grande do Sul, 90020 090
Study site
Rio de Janeiro, 21941-913
Study site
São Paulo, São Paulo, 04012 180
Study site
São Paulo, São Paulo, 04020-050
Portugal4 sites
Study site
Coimbra, 3000-075
Study site
Lisbon, 1169-024
Study site
Lisbon, 1649-035
Study site
Porto, 4099-001
South Korea4 sites
Study site
Seoul, Seoul Teugbyeolsi, 03080
Study site
Seoul, 03722
Study site
Seoul, 05505
Study site
Seoul, 06351
United Kingdom4 sites
Study site
Cambridge, Cambridgeshire, CB23 3RE
Study site
Clydebank, West Dunbartonshire, G81 4DY
Study site
London, NW3 2QG
Study site
London, W12 0HS
Austria3 sites
Study site
Innsbruck, 6020
Study site
Linz, Upper Austria, 4020
Study site
Vienna, 1090
Canada3 sites
Study site
Calgary, Alberta, T1Y 6J4
Study site
Montreal, Quebec, H3T 1E2
Study site
Toronto, Ontario, M5G 2N2
Spain3 sites
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Seville, 41013
Sweden3 sites
Study site
Linköping, 581 85
Study site
Lund, 221 85
Study site
Umeå, 901 85
Taiwan3 sites
Study site
Kaohsiung City, 813414
Study site
Taipei, 100
Study site
Taipei, 11217
Turkey (Türkiye)3 sites
Study site
Ankara
Study site
Istanbul, 34098
Study site
Izmir, 35-100
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).
- Conditions
- Pulmonary Hypertension
- Being tested
- Riociguat (Adempas, BAY63-2521), Placebo
- Keywords
- Pulmonary arterial hypertension, PH, Stimulator
- 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
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Riociguat (Adempas, BAY63-2521)Drug
BAY63-2521: 1.5mg tid orally for 12 weeks
PlaceboDrug
Matching Placebo tid orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT | Experimental | Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks Receives: Drug: Riociguat (Adempas, BAY63-2521) |
| Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT | Experimental | Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks Receives: Drug: Riociguat (Adempas, BAY63-2521) |
| Placebo | Placebo comparator | Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12
6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.
Measured: Baseline and week 12
Secondary outcomes (7)
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12
The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO
Measured: Baseline and week 12
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12
N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
Measured: Baseline and week 12
World Health Organization (WHO) Functional Class - Change From Baseline to Week 12
The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.
Measured: Baseline and week 12
Percentage of Participants With Clinical Worsening
The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH .
Measured: At week 12
Borg CR 10 Scale - Change From Baseline to Week 12
The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal").
Measured: Baseline and week 12
EQ-5D Utility Score - Change From Baseline to Week 12
EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).
Measured: Baseline and week 12
Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12
The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst).
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study start17 Dec 2008
- Primary completion14 May 2012
- Study completion14 May 2012
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 (10)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 445 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
- NCT00810693
- Sponsor's protocol ID
- 12934
- Other IDs
- 2008-003482-68, 2008
- Acronym
- PATENT-1
- Status last verified
- Nov 2023
- First submitted
- 17 Dec 2008
- Last updated
- 22 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684. No abstract available.
PubMed 23883383Ghofrani HA, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.
PubMed 23883378Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.
PubMed 26135803Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.
PubMed 27326239Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2.
PubMed 27263466Benza 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 34353714Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.
PubMed 27457511Saleh 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 27162632
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT00810693
- Acronym / sponsor ID
- PATENT-1 / 12934
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary arterial hypertension, PH, Stimulator
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2008 (actual)
- Primary completion
- 14 May 2012 (actual)
- Study completion
- 14 May 2012 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Posted 26 Feb 2014
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 the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT | Experimental | Drug: Riociguat (Adempas, BAY63-2521)Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks |
| Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT | Experimental | Drug: Riociguat (Adempas, BAY63-2521)Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
- Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).
Key exclusion criteria (1 listed)
- All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.
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: 1mg tid - 2.5mg tid orally for 12 weeks | Drug | Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT |
| Riociguat (Adempas, BAY63-2521)BAY63-2521: 1.5mg tid orally for 12 weeks | Drug | Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT |
| PlaceboMatching Placebo tid orally for 12 weeks | Drug | Placebo |
Primary outcome
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12
Time frame: Baseline and week 12
6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.
7 secondary outcomes
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12
Time frame: Baseline and week 12
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12
Time frame: Baseline and week 12
World Health Organization (WHO) Functional Class - Change From Baseline to Week 12
Time frame: Baseline and week 12
Percentage of Participants With Clinical Worsening
Time frame: At week 12
Borg CR 10 Scale - Change From Baseline to Week 12
Time frame: Baseline and week 12
EQ-5D Utility Score - Change From Baseline to Week 12
Time frame: Baseline and week 12
Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12
Time frame: Baseline and week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23883383Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684. No abstract available.
- Results publication: PubMed 23883378Ghofrani HA, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.
- Results publication: PubMed 26135803Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.
- Results publication: PubMed 27326239Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.
- Results publication: PubMed 27263466Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2.
- Results publication: 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.
- Results publication: 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 27457511Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.
- 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.
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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
122 sites in 30 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 122 sites in 30 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 22 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 122 sites in United States, Japan, Germany, France, Australia and 25 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. Some participants in this study may receive a placebo. 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 26 Feb 2014). 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?
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12 (time frame: Baseline and week 12). 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 NCT00810693, which also lists 10 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 22 Nov 2023.