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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507001-34-00 | Other Identifier | CTIS (EU) | |
| 2009-015878-35 | EudraCT Number |
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The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction
Pharmacokinetics parameters were regarded as exploratory parameters. Adverse event data will be covered in Adverse events section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) up to 2 mg | Experimental | Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg). |
|
| Riociguat (Adempas, BAY63-2521) up to 1 mg | Experimental | Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg). |
|
| Riociguat (Adempas, BAY63-2521) fixed 0.5 mg | Experimental | Participants received riociguat 0.5 mg tid (fixed dose). |
|
| Placebo | Placebo Comparator | Participants received placebo tid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Drug | up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16 | Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization. | Baseline and visit 6 (16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16 | The mixed venous oxygen saturation rate (SvO2) is a directly measured hemodynamic parameter. SvO2 is recorded during a right heart catheterization. | Baseline and visit 6 (16 weeks) |
| Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90073-1003 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22719060 | Result | Ghio S, Bonderman D, Felix SB, Ghofrani HA, Michelakis ED, Mitrovic V, Oudiz RJ, Frey R, Roessig L, Semigran MJ. Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): rationale and design. Eur J Heart Fail. 2012 Aug;14(8):946-53. doi: 10.1093/eurjhf/hfs071. Epub 2012 Jun 20. | |
| 23775260 |
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Availability of this study's data will later 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.vivli.org 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 member section of the portal.
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301 subjects were screened in 84 study centers in 18 countries worldwide. 99 of the 301 screened subjects were not randomized (adverse event [1], protocol violation [1], screen failure [87], withdrawal by subject [10]). Of the 202 subjects randomized, one subject did not receive any study medication.
Only subjects with symptomatic pulmonary hypertension associated with left ventricular systolic dysfunction (PH-sLVD) could participate in this study. Subjects must have been pre-treated with optimized CHF therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Riociguat (Adempas, BAY63-2521) up to 2 mg | Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg). |
| FG001 | Riociguat (Adempas, BAY63-2521) up to 1 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Riociguat (Adempas, BAY63-2521) | Drug | up to 1 mg three times a day (increasing from 0.5 to 1 mg) |
|
| Riociguat (Adempas, BAY63-2521) | Drug | fixed 0.5 mg three times a day |
|
| Placebo | Drug | Placebo three times a day |
|
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 |
| Baseline and visit 6 (16 weeks) |
| Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16 | The pulmonary vascular resistance index (PVRi) is a calculated hemodynamic parameter. PVRi is derived from the pulmonary vascular resistance (PVR) normalized by the body surface area (BSA). Formula: PVRi = 80*(PAPmean - PCWP)*BSA/CO | Baseline and visit 6 (16 weeks) |
| Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16 | The systemic vascular resistance (SVR) is a calculated hemodynamic parameter. SVR is derived from the directly measured parameter mean right atrial pressure (RAPmean) and the calculated parameter mean systemic arterial pressure (SAPmean) divided by the cardiac output (CO). RAPmean is acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: SVR = 80*(SAPmean - RAPmean)/CO | Baseline and visit 6 (16 weeks) |
| Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16 | The systemic vascular resistance index (SVRi) is a calculated hemodynamic parameter. SVRi is derived from the systemic vascular resistance (SVR) normalized by the body surface area (BSA). Formula: SVRi = 80*(SAPmean - RAPmean)*BSA/CO | Baseline and visit 6 (16 weeks) |
| Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16 | The transpulmonary pressure gradient (TPG) is a calculated hemodynamic parameter. TPG is calculated from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP). These 2 parameters are acquired during a right heart catheterization. Formula: TPG = PAPmean - PCWP | Baseline and visit 6 (16 weeks) |
| Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16 | Pulmonary capillary wedge pressure (PCWP) is a directly measured hemodynamic parameter acquired during a right heart catheterization. | Baseline and visit 6 (16 weeks) |
| Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16 | The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Baseline and visit 6 (16 weeks) |
| Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16 | Systolic pulmonary arterial pressure (PAPsyst) is a directly measured hemodynamic parameter acquired during a right heart catheterization. | Baseline and visit 6 (16 weeks) |
| Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16 | The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV | Baseline and visit 6 (16 weeks) |
| Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16 | Left ventricular end-systolic volume (LVESV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Baseline and visit 6 (16 weeks) |
| Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16 | Left ventricular end-diastolic volume (LVEDV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Baseline and visit 6 (16 weeks) |
| E-wave Deceleration Time - Change From Baseline to Week 16 | E-wave deceleration time is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Baseline and visit 6 (16 weeks) |
| Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16 | E/A ratio is a measured echocardiography parameter and describes the ratio of mitral peak velocity of early filling to mitral peak velocity of late filling. It is acquired during a non-invasive echocardiography examination. | Baseline and visit 6 (16 weeks) |
| 6-minute Walking Distance (6MWD) - Change From Baseline to Week 16 | 6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity. | Baseline and visit 6 (16 weeks) |
| WHO (World Health Organization) Functional Class - Change From Baseline to Week 16 | The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients 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 visit 6 (16 weeks) |
| 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, including cardiovascular mortality; first hospitalization for a cardiovascular event, including heart failure, acute myocardial infarction, stroke or ventricular arrhythmia; upgrade of the HTx (heart transplantation) status to next higher level; need for IV diuretics; persistent worsening of WHO functional class due to deterioration of PH or cardiac function. | At visit 6 (16 weeks) |
| Borg CR 10 Scale - Change From Baseline to Week 16 | The Borg CR10 Scale is a patient reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the patient's exertion during a physical test. Low values indicate low levels of exertion, high values indicate more intense exertion reported by the patient. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal"). | Baseline and visit 6 (16 weeks) |
| EQ-5D Utility Score - Change From Baseline to Week 16 | EQ-5D utility score is a Quality-of-Life patient reported outcome measure. An increase in the utility score represents an improvement in quality of life. The score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | Baseline and visit 6 (16 weeks) |
| Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16 | The self-reported Minnesota Living with Heart Failure questionnaire (MLHF) is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The MLHF total score can range from 0 (best) to 105 (worst). | Baseline and visit 6 (16 weeks) |
| Cystatin C - Change From Baseline to Week 16 | Cystatin C is a biomarker for predicting new onset or deteriorating cardiovascular disease. | Baseline and visit 6 (16 weeks) |
| N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16 | N-terminal pro-brain natriuretic peptide (NT-pro BNP) 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 visit 6 (16 weeks) |
| Troponin T - Change From Baseline to Week 16 | Troponin T is a cardiac-specific protein which is released from damaged or injured heart muscle cells. | Baseline and visit 6 (16 weeks) |
| Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16 | Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxides. Recent clinical studies have indicated that ADMA may have diagnostic relevance as a novel cardiovascular risk marker. | Baseline and visit 6 (16 weeks) |
| Osteopontin - Change From Baseline to Week 16 | Osteopontin is a cytokine-like pro-fibrotic mediator, which is expressed in cardiovascular tissues. Its expression is induced by increased pressure and volume load in the myocardium, kidney and lung. Therefore, osteopontin may be used as a prognostic marker in patients with cardiovascular diseases. | Baseline and visit 6 (16 weeks) |
| San Diego |
| California |
| 92103 |
| United States |
| Torrance | California | 90502 | United States |
| Westminster | California | 92683 | United States |
| Miami | Florida | 33136 | United States |
| Iowa City | Iowa | 52242 | United States |
| Baltimore | Maryland | 21201 | United States |
| Boston | Massachusetts | 02114-2696 | United States |
| Rochester | Minnesota | 55905 | United States |
| St Louis | Missouri | 63110 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Fairfield | Ohio | 45014 | United States |
| Falls Church | Virginia | 22042 | United States |
| Milwaukee | Wisconsin | 53215 | United States |
| Sydney | New South Wales | 2010 | Australia |
| Herston | Queensland | 4029 | Australia |
| Melbourne | Victoria | 3004 | Australia |
| Innsbruck | Tyrol | 6020 | Austria |
| Vienna | 1090 | Austria |
| Aalst | 9300 | Belgium |
| Brussels | 1070 | Belgium |
| Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Québec | G1V 4G5 | Canada |
| Beijing | 100020 | China |
| Shanghai | 200032 | China |
| Shanghai | 200433 | China |
| Brno | 656 91 | Czechia |
| Olomouc | 77900 | Czechia |
| Prague | 12808 | Czechia |
| Prague | 140 21 | Czechia |
| Aarhus N | 8200 | Denmark |
| Bron | 69677 | France |
| Lille | 59037 | France |
| Nantes | 44035 | France |
| Pessac | 33604 | France |
| Rouen | 76031 | France |
| Toulouse | 31059 | France |
| Heidelberg | Baden-Wurttemberg | 69115 | Germany |
| Augsburg | Bavaria | 86156 | Germany |
| Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| Cologne | North Rhine-Westphalia | 50937 | Germany |
| Erfurt | Thuringia | 99089 | Germany |
| Naples | Campania | 80131 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Nagoya | Aichi-ken | 466-8560 | Japan |
| Seto | Aichi-ken | 489-8642 | Japan |
| ÅŒgaki | Gifu | 503-8502 | Japan |
| Higashiibaraki | Ibaraki | 311-3193 | Japan |
| Tsu | Mie-ken | 514-1101 | Japan |
| Sendai | Miyagi | 980-8574 | Japan |
| Kita-ku, Osaka | Osaka | 530-8480 | Japan |
| Osaka | Osaka | 541-8567 | Japan |
| Suita | Osaka | 565-0871 | Japan |
| Kusatsu | Shiga | 525-8585 | Japan |
| Sunto | Shizuoka | 411-8611 | Japan |
| Arakawa-ku | Tokyo | 116-8567 | Japan |
| Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Tanabe | Wakayama | 646-8558 | Japan |
| Amsterdam | 1081 HV | Netherlands |
| Amsterdam | 1091 AC | Netherlands |
| Nijmegen | 6525 GA | Netherlands |
| Bydgoszcz | 85-168 | Poland |
| Gdansk | 80-214 | Poland |
| Warsaw | 04-628 | Poland |
| Singapore | 119074 | Singapore |
| Singapore | 169609 | Singapore |
| Singapore | 308433 | Singapore |
| A Coruña | A Coruña | 15006 | Spain |
| Majadahonda | Madrid | 28222 | Spain |
| Palma | Palma de Mallorca | 7198 | Spain |
| Barcelona | 08003 | Spain |
| Madrid | 28041 | Spain |
| Murcia | 30120 | Spain |
| Valencia | 46026 | Spain |
| Geneva | Canton of Geneva | 1205 | Switzerland |
| Lugano | Canton Ticino | 6900 | Switzerland |
| Zurich | 8091 | Switzerland |
| Cambridge | Cambridgeshire | CB2 0AY | United Kingdom |
| London | SW3 6NP | United Kingdom |
| Bonderman D, Ghio S, Felix SB, Ghofrani HA, Michelakis E, Mitrovic V, Oudiz RJ, Boateng F, Scalise AV, Roessig L, Semigran MJ; Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group. Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: a phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study. Circulation. 2013 Jul 30;128(5):502-11. doi: 10.1161/CIRCULATIONAHA.113.001458. Epub 2013 Jun 17. |
Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
| FG002 | Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg | Participants received riociguat 0.5 mg tid (fixed dose). |
| FG003 | Placebo | Participants received placebo tid. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Riociguat (Adempas, BAY63-2521) up to 2 mg | Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg). |
| BG001 | Riociguat (Adempas, BAY63-2521) up to 1 mg | Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg). |
| BG002 | Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg | Participants received riociguat 0.5 mg tid (fixed dose). |
| BG003 | Placebo | Participants received placebo tid. |
| BG004 | 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 |
| ||||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| 6-minute walking distance | 6MWD is a measure for the evaluation of functional exercise capacity. | Mean | Standard Deviation | Meters |
| ||||||||||||||
| Left ventricular ejection fraction (LVEF) | LVEF is a calculated echocardiography parameter. | Mean | Standard Deviation | Percentage |
| ||||||||||||||
| Etiology | Count of Participants | Participants |
| ||||||||||||||||
| WHO (World Health Organization) functional class | The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement, changes to a higher functional class resemble deterioration of pulmonary arterial hypertension (PAH). | Count of Participants | Participants |
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| Number of participants with diabetes mellitus (including subtypes) | Count of Participants | Participants |
| ||||||||||||||||
| Glomerular filtration rate (GFR) | Mean | Standard Deviation | mL/min/1.73m^2 |
| |||||||||||||||
| Number of participants with atrial fibrillation | Count of Participants | Participants |
| ||||||||||||||||
| Number of participants with atrial flutter | Count of Participants | Participants |
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| Number of participants with pacemaker rhythm | Count of Participants | Participants |
| ||||||||||||||||
| Baseline drug and device therapy | A single patient could have more than one drug and device therapy. | Count of Participants | Participants |
|
| 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 | Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16 | Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF [safety analysis set]/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline and visit 6 (16 weeks) |
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| Secondary | Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16 | The mixed venous oxygen saturation rate (SvO2) is a directly measured hemodynamic parameter. SvO2 is recorded during a right heart catheterization. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | Percentage | Baseline and visit 6 (16 weeks) |
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| Secondary | Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16 | 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 | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | dyn*s*cm^-5 | Baseline and visit 6 (16 weeks) |
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| Secondary | Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16 | The pulmonary vascular resistance index (PVRi) is a calculated hemodynamic parameter. PVRi is derived from the pulmonary vascular resistance (PVR) normalized by the body surface area (BSA). Formula: PVRi = 80*(PAPmean - PCWP)*BSA/CO | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | dyn*s*cm^-5*m^2 | Baseline and visit 6 (16 weeks) |
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| Secondary | Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16 | The systemic vascular resistance (SVR) is a calculated hemodynamic parameter. SVR is derived from the directly measured parameter mean right atrial pressure (RAPmean) and the calculated parameter mean systemic arterial pressure (SAPmean) divided by the cardiac output (CO). RAPmean is acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: SVR = 80*(SAPmean - RAPmean)/CO | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | dyn*s*cm^-5 | Baseline and visit 6 (16 weeks) |
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| Secondary | Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16 | The systemic vascular resistance index (SVRi) is a calculated hemodynamic parameter. SVRi is derived from the systemic vascular resistance (SVR) normalized by the body surface area (BSA). Formula: SVRi = 80*(SAPmean - RAPmean)*BSA/CO | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | dyn*s*cm^-5*m^2 | Baseline and visit 6 (16 weeks) |
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| Secondary | Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16 | The transpulmonary pressure gradient (TPG) is a calculated hemodynamic parameter. TPG is calculated from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP). These 2 parameters are acquired during a right heart catheterization. Formula: TPG = PAPmean - PCWP | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline and visit 6 (16 weeks) |
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| Secondary | Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16 | Pulmonary capillary wedge pressure (PCWP) is a directly measured hemodynamic parameter acquired during a right heart catheterization. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline and visit 6 (16 weeks) |
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| Secondary | Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16 | The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | mm | Baseline and visit 6 (16 weeks) |
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| Secondary | Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16 | Systolic pulmonary arterial pressure (PAPsyst) is a directly measured hemodynamic parameter acquired during a right heart catheterization. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline and visit 6 (16 weeks) |
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| Secondary | Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16 | The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | Percentage | Baseline and visit 6 (16 weeks) |
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| Secondary | Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16 | Left ventricular end-systolic volume (LVESV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | mL | Baseline and visit 6 (16 weeks) |
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| Secondary | Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16 | Left ventricular end-diastolic volume (LVEDV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | mL | Baseline and visit 6 (16 weeks) |
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| Secondary | E-wave Deceleration Time - Change From Baseline to Week 16 | E-wave deceleration time is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | msec | Baseline and visit 6 (16 weeks) |
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| Secondary | Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16 | E/A ratio is a measured echocardiography parameter and describes the ratio of mitral peak velocity of early filling to mitral peak velocity of late filling. It is acquired during a non-invasive echocardiography examination. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | E/A ratio | Baseline and visit 6 (16 weeks) |
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| Secondary | 6-minute Walking Distance (6MWD) - Change From Baseline to Week 16 | 6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | m | Baseline and visit 6 (16 weeks) |
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| Secondary | WHO (World Health Organization) Functional Class - Change From Baseline to Week 16 | The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients 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. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Number | Percentage of participants | Baseline and visit 6 (16 weeks) |
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| 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, including cardiovascular mortality; first hospitalization for a cardiovascular event, including heart failure, acute myocardial infarction, stroke or ventricular arrhythmia; upgrade of the HTx (heart transplantation) status to next higher level; need for IV diuretics; persistent worsening of WHO functional class due to deterioration of PH or cardiac function. | 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. | Posted | Number | Percentage of participants | At visit 6 (16 weeks) |
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| Secondary | Borg CR 10 Scale - Change From Baseline to Week 16 | The Borg CR10 Scale is a patient reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the patient's exertion during a physical test. Low values indicate low levels of exertion, high values indicate more intense exertion reported by the patient. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal"). | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and visit 6 (16 weeks) |
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| Secondary | EQ-5D Utility Score - Change From Baseline to Week 16 | EQ-5D utility score is a Quality-of-Life patient reported outcome measure. An increase in the utility score represents an improvement in quality of life. The score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and visit 6 (16 weeks) |
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| Secondary | Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16 | The self-reported Minnesota Living with Heart Failure questionnaire (MLHF) is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The MLHF total score can range from 0 (best) to 105 (worst). | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and visit 6 (16 weeks) |
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| Secondary | Cystatin C - Change From Baseline to Week 16 | Cystatin C is a biomarker for predicting new onset or deteriorating cardiovascular disease. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | ng/mL | Baseline and visit 6 (16 weeks) |
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| Secondary | N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16 | N-terminal pro-brain natriuretic peptide (NT-pro BNP) 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. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | pg/mL | Baseline and visit 6 (16 weeks) |
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| Secondary | Troponin T - Change From Baseline to Week 16 | Troponin T is a cardiac-specific protein which is released from damaged or injured heart muscle cells. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | µg/L | Baseline and visit 6 (16 weeks) |
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| Secondary | Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16 | Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxides. Recent clinical studies have indicated that ADMA may have diagnostic relevance as a novel cardiovascular risk marker. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | µmol/L | Baseline and visit 6 (16 weeks) |
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| Secondary | Osteopontin - Change From Baseline to Week 16 | Osteopontin is a cytokine-like pro-fibrotic mediator, which is expressed in cardiovascular tissues. Its expression is induced by increased pressure and volume load in the myocardium, kidney and lung. Therefore, osteopontin may be used as a prognostic marker in patients with cardiovascular diseases. | Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis. | Posted | Mean | Standard Deviation | µg/mL | Baseline and visit 6 (16 weeks) |
|
All Adverse Events occurring between the subject has signed the informed consent and 30 days after the definite stop of study medication (over a period approximately 25 months) were reported.
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 mg | Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg). | 23 | 67 | 57 | 67 | ||
| EG001 | Riociguat (Adempas, BAY63-2521) up to 1 mg | Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg) | 7 | 33 | 28 | 33 | ||
| EG002 | Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg | Participants received riociguat 0.5 mg tid (fixed dose) | 7 | 32 | 25 | 32 | ||
| EG003 | Placebo | Participants received placebo tid | 18 | 69 | 49 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary 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 |
| |
| Gastroenteritis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyperphagia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Critical illness polyneuropathy | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Heart transplant | Surgical and medical procedures | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac pacemaker replacement | Surgical and medical procedures | MedDRA (15.0) | Non-systematic Assessment |
| |
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA (15.0) | Non-systematic Assessment |
| |
| Implantable defibrillator replacement | Surgical and medical procedures | 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 |
| |
| Haemodynamic instability | 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 |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pulmonary valve incompetence | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Visual impairment | Eye 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 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 |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyperchlorhydria | 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 |
| |
| Chest discomfort | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Herpes zoster | 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 |
| |
| Localised infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Tonsillitis | 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 |
| |
| Tooth infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| International normalised ratio abnormal | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pulmonary arterial wedge pressure increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Glutamate dehydrogenase increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Electrocardiogram repolarisation abnormality | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Appetite disorder | 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 |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Muscular weakness | 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 |
| |
| Neck pain | 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 |
| |
| Bone swelling | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Orthostatic intolerance | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Urine odour abnormal | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Erection increased | Reproductive system and breast 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 |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Arteriosclerosis Moenckeberg-type | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
|
Subjects had advanced disease and were heavily pretreated. Baseline values were not comparable between treatment groups.
The Investigative Site, Institution and/or Principal Investigator shall furnish the Sponsor with a copy of any proposed publication of material at least sixty (60) days in advance of the date of submission for publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542595 | riociguat |
Not provided
Not provided
Not provided
| Death |
|
| Lost to Follow-up |
|
| Progressive disease |
|
| Withdrawal by Subject |
|
| study ongoing |
|
| Male |
|
| Non-ischemic cardiomyopathy |
|
| Data missing |
|
| III |
|
| IV |
|
| Angiotensin-converting enzyme inhibitors |
|
| Angiotensin II receptor blockers |
|
| Aldosterone antagonists |
|
| Beta-blockers |
|
| Beta-blockers with alpha-blocking activity |
|
| Loop diuretics |
|
| Thiazide diuretics |
|
| Cardiac glycosides |
|
| Oral anticoagulants |
|
| Amiodarone |
|
| 0.5292 |
Baseline value, treatment group and region were used as fixed effects in the ANCOVA model |
| LSMEANS Difference |
| -1.38 |
| 2-Sided |
| 95 |
| -5.71 |
| 2.94 |
| Superiority or Other (legacy) |
| ANCOVA | 0.0278 | Baseline value, treatment group and region were used as fixed effects in the ANCOVA model | LS-MEANS Difference | -4.51 | 2-Sided | 95 | -8.52 | -0.50 | Superiority or Other (legacy) |
| ANCOVA | 0.3821 | Baseline value, treatment group and region were used as fixed effects in the ANCOVA model | LS-MEANS Difference | 1.80 | 2-Sided | 95 | -2.25 | 5.84 | Superiority or Other (legacy) |
| ANCOVA | 0.2084 | Baseline value, treatment group and region were used as fixed effects in the ANCOVA model | LS-MEANS Difference | 3.13 | 2-Sided | 95 | -1.76 | 8.02 | Superiority or Other (legacy) |
| ANCOVA | 0.5442 | Baseline value, treatment group and region were used as fixed effects in the ANCOVA model | LS-MEANS Difference | -1.33 | 2-Sided | 95 | -5.66 | 3.00 | Superiority or Other (legacy) |
Participants received placebo tid.
|
|
|
| OG003 | Placebo | Participants received placebo tid. |
|
|
|
| Placebo |
Participants received placebo tid. |
|
|
|
| OG003 | Placebo | Participants received placebo tid. |
|
|
|
| Placebo |
Participants received placebo tid. |
|
|
|
| OG003 | Placebo | Participants received placebo tid. |
|
|
|
Participants received placebo tid.
|
|
|
Participants received placebo tid. |
|
|
|
Participants received placebo tid.
|
|
|
| OG003 | Placebo | Participants received placebo tid. |
|
|
|
Participants received placebo tid. |
|
|
|
Participants received placebo tid. |
|
|
|
Participants received placebo tid.
|
|
|
| OG003 |
| Placebo |
Participants received placebo tid. |
|
|
|
Participants received placebo tid.
|
|
|
Participants received riociguat 0.5 mg tid (fixed dose).
| OG003 | Placebo | Participants received placebo tid. |
|
|
Participants received riociguat 0.5 mg tid (fixed dose).
| OG003 | Placebo | Participants received placebo tid. |
|
|
|
| OG003 | Placebo | Participants received placebo tid. |
|
|
| Placebo |
Participants received placebo tid. |
|
|
|
| OG003 |
| Placebo |
Participants received placebo tid. |
|
|
|
|
|
|
| Placebo |
Participants received placebo tid. |
|
|
|
|
|
|
Participants received placebo tid. |
|
|
|
| OG003 |
| Placebo |
Participants received placebo tid. |
|
|
|