Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003482-68 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Placebo | Placebo Comparator | Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Drug | BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85724 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23883383 | Result | 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. | |
| 23883378 | Result | Ghofrani 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. |
Not provided
Not provided
586 participants were enrolled in 124 study centers in 30 countries worldwide. 141 of the 586 enrolled participants were not randomized (adverse event [4], protocol violation [129], withdrawal by subject [8]). 445 of the 586 participants were randomized. 443 of the 445 randomized participants received study medication.
Only participants with symptomatic Pulmonary arterial hypertension (PAH) could participate in this study. Both treatment-naïve participants and participants pre-treated with an endothelin receptor antagonist or a non-intravenous prostacyclin analogue could be included.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT | 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 |
| FG001 | Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Riociguat (Adempas, BAY63-2521) | Drug | BAY63-2521: 1.5mg tid orally for 12 weeks |
|
| Placebo | Drug | Matching Placebo tid orally for 12 weeks |
|
| 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. | 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. | 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 . | 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"). | 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). | 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). | Baseline and week 12 |
| La Jolla |
| California |
| 92037 |
| United States |
| Los Angeles | California | 90073 | United States |
| Sacramento | California | 95817 | United States |
| Aurora | Colorado | 80045 | United States |
| Louisville | Kentucky | 40202 | United States |
| Boston | Massachusetts | 02111 | United States |
| Boston | Massachusetts | 02115 | United States |
| Omaha | Nebraska | 68131 | United States |
| New York | New York | 10032 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cleveland | Ohio | 44195 | United States |
| Columbus | Ohio | 43221 | United States |
| Fairfield | Ohio | 45014 | United States |
| Providence | Rhode Island | 02903 | United States |
| Dallas | Texas | 75390 | United States |
| El Paso | Texas | 79902 | United States |
| Houston | Texas | 77030 | United States |
| Capital Federal | Argentina |
| Darlinghurst | New South Wales | 2010 | Australia |
| New Lambton Heights | New South Wales | 2305 | Australia |
| Auchenflower | Queensland | 4066 | Australia |
| Herston | Queensland | 4029 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Prahran | Victoria | 3181 | Australia |
| Linz | Upper Austria | 4020 | Austria |
| Innsbruck | 6020 | Austria |
| Vienna | 1090 | Austria |
| Bruxelles - Brussel | 1070 | Belgium |
| Leuven | 3000 | Belgium |
| Porto Alegre | Rio Grande do Sul | 90020 090 | Brazil |
| São Paulo | São Paulo | 04012 180 | Brazil |
| São Paulo | São Paulo | 04020-050 | Brazil |
| Rio de Janeiro | 21941-913 | Brazil |
| Calgary | Alberta | T1Y 6J4 | Canada |
| Toronto | Ontario | M5G 2N2 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Guangzhou | Guangdong | 510100 | China |
| Beijing | 100020 | China |
| Beijing | 100037 | China |
| Shanghai | 200032 | China |
| Shanghai | 200433 | China |
| Prague | 12808 | Czechia |
| Aarhus N | 8200 | Denmark |
| Besançon | 25030 | France |
| Brest | F-29609 | France |
| Grenoble | 38043 | France |
| Lille | 59037 | France |
| Montpellier | 34059 | France |
| Nice | 06200 | France |
| Pessac | 33604 | France |
| Rouen | 76031 | France |
| Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| München | Bavaria | 81377 | Germany |
| Giessen | Hesse | 35392 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| Cologne | North Rhine-Westphalia | 50924 | Germany |
| Homburg | Saarland | 66421 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Chaïdári | 124 62 | Greece |
| Petah Tikva | 4941492 | Israel |
| Trieste | Friuli Venezia Giulia | 34149 | Italy |
| Rome | Lazio | 00161 | Italy |
| Milan | Lombardy | 20123 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Turin | Piedmont | 10043 | Italy |
| Nagoya | Aichi-ken | 467-8602 | Japan |
| Yoshida | Fukui | 910-1193 | Japan |
| Kobe | Hyōgo | 650-0017 | Japan |
| Toride | Ibaraki | 302-0022 | Japan |
| Tsukuba | Ibaraki | 305-8576 | Japan |
| Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Sagamihara | Kanagawa | 252-0375 | Japan |
| Sendai | Miyagi | 980-8574 | Japan |
| Tomigusuku | Okinawa | 901-0243 | Japan |
| Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Mitaka | Tokyo | 181-8611 | Japan |
| Ōta-ku | Tokyo | 143-8541 | Japan |
| Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Hiroshima | 734-8551 | Japan |
| Okayama | 701-1192 | Japan |
| Guadalajara | Jalisco | 44280 | Mexico |
| Guadalajara | Jalisco | 44670 | Mexico |
| Monterrey | Nuevo León | 64020 | Mexico |
| Culiacán | Sinaloa | 80020 | Mexico |
| Mexico City | 14080 | Mexico |
| Querétaro | 38000 | Mexico |
| Christchurch | 8011 | New Zealand |
| Otwock | 05-400 | Poland |
| Coimbra | 3000-075 | Portugal |
| Lisbon | 1169-024 | Portugal |
| Lisbon | 1649-035 | Portugal |
| Porto | 4099-001 | Portugal |
| Moscow | 121552 | Russia |
| Saint Petersburg | 197341 | Russia |
| Singapore | 119228 | Singapore |
| Singapore | 168752 | Singapore |
| Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Seoul | 03722 | South Korea |
| Seoul | 05505 | South Korea |
| Seoul | 06351 | South Korea |
| Barcelona | 08035 | Spain |
| Barcelona | 08036 | Spain |
| Seville | 41013 | Spain |
| Linköping | 581 85 | Sweden |
| Lund | 221 85 | Sweden |
| Umeå | 901 85 | Sweden |
| Zurich | 8091 | Switzerland |
| Kaohsiung City | 813414 | Taiwan |
| Taipei | 100 | Taiwan |
| Taipei | 11217 | Taiwan |
| Bangkok | 10330 | Thailand |
| Chiang Mai | 50200 | Thailand |
| Ankara | Turkey (Türkiye) |
| Istanbul | 34098 | Turkey (Türkiye) |
| Izmir | 35-100 | Turkey (Türkiye) |
| Cambridge | Cambridgeshire | CB23 3RE | United Kingdom |
| Clydebank | West Dunbartonshire | G81 4DY | United Kingdom |
| London | NW3 2QG | United Kingdom |
| London | W12 0HS | United Kingdom |
| 26135803 | Result | Rosenkranz 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. |
| 27326239 | Result | Wang 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. |
| 27263466 | Result | Ghofrani 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. |
| 34848133 | Result | 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. |
| 35256218 | Result | Benza 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. |
| 34353714 | Derived | Benza 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. |
| 27457511 | Derived | Humbert 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. |
| 27162632 | Derived | Saleh 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. |
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 |
| FG002 | Placebo | Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks |
| Participants Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period (FUP) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT | 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 |
| BG001 | Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT | 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 |
| BG002 | Placebo | Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Prior PH therapy | Number | Participants |
| ||||||||||||||||
| pre-treated with endothelin receptor antagonist | Subjects pre-treated with an endothelin receptor antagonist. | Number | Participants |
| |||||||||||||||
| pre-treated with prostacyclin analogue | Subjects pre-treated with a prostacyclin analogue. | Number | Participants |
| |||||||||||||||
| PAH subtype | Subtypes acc. to the Venice Clinical Classification of PH, Group 1 (idiopathic PAH, familial PAH, associated PAH due to [1] connective tissue disease, [2] congenital heart disease, [3] portal hypertension with liver cirrhosis, or [4] anorexigen or amphetamine use) | Number | Participants |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Baseline 6MWD | 6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity. | Mean | Standard Deviation | meters |
| ||||||||||||||
| WHO (World Health Organization) functional class | 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. | Number | Participants |
| |||||||||||||||
| Pulmonary vascular resistance | 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 | Mean | Standard Deviation | dn*s*cm^-5 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. | Posted | Mean | Standard Deviation | Meters | Baseline and week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR. | Posted | Mean | Standard Deviation | dyn*s*cm^-5 | Baseline and week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP. | Posted | Mean | Standard Deviation | pg/mL | Baseline and week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class. | Posted | Number | Percentage of participants | Baseline and week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 . | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. | Posted | Number | Percentage of participants | At week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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"). | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and week 12 |
|
Adverse event data were collected after signing the informed consent until 2 days after end of study treatment over a period of approximately 30 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT | 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 | 29 | 254 | 216 | 254 | ||
| EG001 | Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT | 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 | 11 | 63 | 57 | 63 | ||
| EG002 | Placebo | Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks | 23 | 126 | 96 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Encephalitis herpes | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Catheterisation cardiac | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Electrocardiogram ST-T segment abnormal | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
|
The embargo can be up to 6 months (equal to the 180 days), moreover if it is necessary the embargo period can be prolonged to expiry of priority year.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542595 | riociguat |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Mixed |
|
| Not reported |
|
| Pre-Treated |
|
| No |
|
| No |
|
| Familial PAH |
|
| Connective tissue disease assoc. PAH |
|
| Congenital heart disease (operated) assoc. PAH |
|
| Portal Pulmonary hypertension |
|
| Anorexigen or Amphtamin assoc: PAH |
|
| II |
|
| III |
|
| IV |
|
| missing |
|
| Superiority or Other (legacy) |
| ANCOVA | <0.0001 | Additional analysis due to result of Shapiro-Wilk test. | Mean Difference (Final Values) | 35.78 | 2-Sided | 95 | 20.06 | 51.51 | Superiority or Other (legacy) |
| Shapiro-Wilk test for normality of ANCOVA residuals. | Shapiro-Wilk | 0.0001 | Superiority or Other (legacy) |
| Placebo |
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks |
|
|
|
|
|
|
| OG002 |
| Placebo |
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks |
|
|
|
|
|
|
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
|
|
|
| Placebo |
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks |
|
|
|
|
|
|