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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024332-42 | EudraCT Number |
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Study terminated per recommendation of iDMC. On iDMC request, protocol amended to include 4-month safety follow-up for patients after withdrawal of riociguat.
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To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).
Number of participants with Adverse Events (AEs) will be reported in Adverse Events section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Experimental | In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. |
|
| Placebo | Placebo Comparator | In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Drug | Active drug 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration. The starting dose will be 0.5 mg TID, and the dose will be adjusted every two weeks for ten weeks in 0.5 mg increments up to a maximum dose of 2.5 mg TID based on patient's systolic blood pressure and well-being. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26 | The 6MWD test is designed to evaluate a patient's exercise capacity while performing an everyday activity. | Baseline to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number 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; need for hospitalization due to worsening cardiopulmonary (CP) status, attributable to progression of disease (including but not limited to increased shortness of breath or increased leg swelling); >15% decrease in the 6MWD test; worsening of WHO functional class. |
Not provided
Inclusion Criteria:
Men or women aged from ≥18 to ≤80 years
Diagnosed with one of the following (confirmed using a multidisciplinary approach, as per ATS(American Thoracic Society) / ERS(European Respiratory Society) / JRS (Japanese Respiratory Society) / ALAT(Latin American Thoracic Association) guidelines:
Forced Vital Capacity (FVC) ≥ 45 %
6MWD (6 minutes walking distance) ≥ 150 m to ≤ 450 m {under stable O2(oxygen) supplementation via nasal cannula}
Diagnosis of PH (pulmonary hypertension) confirmed by right heart catheter (RHC) with (mean artery pulmonary artery pressure )mPAP ≥ 25 mmHg and (pulmonary artery wedge pressure)PAWP ≤15 mmHg at rest
Systolic blood pressure (SBP) ≥ 95 mmHg and no signs or symptoms of hypotension
WHO functional class II-IV
Women of childbearing potential can only be included in the study if a pregnancy test is negative. Women of childbearing potential must agree to use adequate contraception when sexually active. 'Adequate contraception' is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Adequate contraception is required from the signing of the informed consent form up until 4 weeks after the last study drug administration
Exclusion Criteria:
Known significant left heart disease:
Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
Any history of bronchial artery embolization or massive hemoptysis within 3 months prior to screening. Massive hemoptysis being defined as acute bleeding >240 mL in a 24-hour period or recurrent bleeding >100 mL/d over several days
Difference > 15% between the eligibility and the baseline 6MWD test
Forced expiratory volume in one second (FEV1) / Forced Vital Capacity (FVC) <0.65 after bronchodilator administration
Initiation in cytotoxic, immunosuppressive, cytokine modulating therapy initiated within 3 months prior to screening. Such agents might include. azathioprine, cyclophosphamide, corticosteroids, etanercept, tumor necrosis factor alpha (TNFα) inhibitors and others
Any specific treatment for (pulmonary arterial hypertension) PAH/PH (pulmonary hypertension )within 3 months prior to screening
Concomitant use of the following medication: nitrates or (nitric oxide) NO donors (such as amyl nitrite) in any form, phosphodiesterase 5 inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific phosphodiesterase (PDE) inhibitors (theophylline, dipyridamole),
Pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women of childbearing potential not using adequate contraception (as defined in the aforementioned inclusion criterion) and not willing to agree to 4 weekly pregnancy testing from Visit 1(first administration of study drug) onwards until 4 weeks after last study drug intake
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90024 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31416769 | Derived | Nathan SD, Behr J, Collard HR, Cottin V, Hoeper MM, Martinez FJ, Corte TJ, Keogh AM, Leuchte H, Mogulkoc N, Ulrich S, Wuyts WA, Yao Z, Boateng F, Wells AU. Riociguat for idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP): a randomised, placebo-controlled phase 2b study. Lancet Respir Med. 2019 Sep;7(9):780-790. doi: 10.1016/S2213-2600(19)30250-4. Epub 2019 Aug 12. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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A total of 147 participants were randomized and entered the main study phase, of whom 73 were assigned to riociguat and 74 to placebo.
Overall, 229 participants were enrolled into the study centers in 19 countries worldwide, from 04-Jun-2014 (first patient first visit) to 14-Sep-2016 (last patient last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Riociguat (Adempas, BAY63-2521) | In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Study Treatment |
|
Not provided
Not provided
Not provided
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Not provided
|
| Placebo | Drug | Inactive dosed at 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration for 26 weeks |
|
| From baseline to week 26 |
| San Francisco |
| California |
| 94143 |
| United States |
| Aurora | Colorado | 80045 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803 | United States |
| Via Christi Clinic | Wichita | Kansas | 67208 | United States |
| Louisville | Kentucky | 40202 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Durham | North Carolina | 27710 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cleveland | Ohio | 44195 | United States |
| Columbus | Ohio | 43221 | United States |
| Portland | Oregon | 97213 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Nashville | Tennessee | 37232-5735 | United States |
| Dallas | Texas | 75235-3858 | United States |
| Falls Church | Virginia | 22042 | United States |
| Mar del Plata | Buenos Aires | Argentina |
| Buenos Aires | Ciudad Auton. de Buenos Aires | 1426 | Argentina |
| Buenos Aires | Ciudad Auton. de Buenos Aires | C1280AEB | Argentina |
| Godoy Cruz | Mendoza Province | 5501 | Argentina |
| San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Camperdown | New South Wales | 2050 | Australia |
| Darlinghurst | New South Wales | 2010 | Australia |
| Sydney | New South Wales | 2751 | Australia |
| Chermside | Queensland | 4032 | Australia |
| Adelaide | South Australia | 5000 | Australia |
| Prahran | Victoria | 3181 | Australia |
| Murdoch | Western Australia | 6150 | Australia |
| Leuven | 3000 | Belgium |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Ottawa | Ontario | K1Y 4W7 | Canada |
| Toronto | Ontario | M5G 2N2 | Canada |
| Québec | G1V 4G5 | Canada |
| Bogotá | Bogota D.C. | Colombia |
| Floridablanca-Bucaramanga | Santander Department | Colombia |
| Cali | Valle del Cauca Department | Colombia |
| Bogotá | Colombia |
| Aarhus N | 8200 | Denmark |
| Bron | 69500 | France |
| Lille | 59037 | France |
| Marseille | 13915 | France |
| Paris | 75908 | France |
| München | Bavaria | 80539 | Germany |
| München | Bavaria | 81377 | Germany |
| Würzburg | Bavaria | 97074 | Germany |
| Giessen | Hesse | 35392 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Essen | North Rhine-Westphalia | 45239 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Großhansdorf | 22927 | Germany |
| Athens | 11527 | Greece |
| Haidari | 12462 | Greece |
| Ioannina | 45500 | Greece |
| Thessaloniki | 570 10 | Greece |
| Haifa | 3436212 | Israel |
| Jerusalem | 91120 | Israel |
| Petah Tikva | 4941492 | Israel |
| Ramat Gan | 5262000 | Israel |
| Forlì-Cesena | Emilia-Romagna | 47121 | Italy |
| Rome | Lazio | 00133 | Italy |
| Monza-Brianza | Lombardy | 20900 | Italy |
| Palermo | Sicily | 90127 | Italy |
| Siena | Tuscany | 53100 | Italy |
| Seto | Aichi-ken | 489-8642 | Japan |
| Yokohama | Kanagawa | 236-0051 | Japan |
| Sakai | Osaka | 591-8555 | Japan |
| Shibuya-ku | Tokyo | 151-8528 | Japan |
| Chiba | 260-8677 | Japan |
| Auckland | 1051 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Coimbra | 3000-075 | Portugal |
| Porto | 4200 | Portugal |
| Vila Nova de Gaia | 4434-502 | Portugal |
| Moscow | 105077 | Russia |
| Moscow | 107564 | Russia |
| Saint Petersburg | 197022 | Russia |
| Vladimir | 600023 | Russia |
| Riyadh | 11211 | Saudi Arabia |
| Riyadh | 11461 | Saudi Arabia |
| Riyadh | 11525 | Saudi Arabia |
| Barcelona | 08003 | Spain |
| Barcelona | 08036 | Spain |
| Valencia | 46014 | Spain |
| Bern | 3010 | Switzerland |
| Geneva | 1205 | Switzerland |
| Zurich | 8091 | Switzerland |
| Denizli | 20070 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Cambridge | Cambridgeshire | CB23 3RE | United Kingdom |
| Clydebank | West Dunbartonshire | G81 4DY | United Kingdom |
| London | SW3 6NP | United Kingdom |
| Newcastle | NE7 7DN | United Kingdom |
| FG001 | Placebo | In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Long-term Extension |
|
|
| Safety Follow-up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Riociguat (Adempas, BAY63-2521) | In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. |
| BG001 | Placebo | In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension (LTE) phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. |
| BG002 | 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, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Pulmonary hypertension (PH) subtype (Nice Clinical Classification) | Number | Participants |
| |||||||||||||||||||
| Classification of Idiopathic Interstitial Pneumonia | Number | Participants |
| |||||||||||||||||||
| World Health Organization (WHO) 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). | Number | Participants |
| ||||||||||||||||||
| 6 minute walking distance (6MWD) category | The 6MWD test is designed to evaluate a patient's exercise capacity while performing an everyday activity. | Number | 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 | Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26 | The 6MWD test is designed to evaluate a patient's exercise capacity while performing an everyday activity. | Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication. | Posted | Mean | Standard Deviation | Meter | Baseline to 26 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number 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; need for hospitalization due to worsening cardiopulmonary (CP) status, attributable to progression of disease (including but not limited to increased shortness of breath or increased leg swelling); >15% decrease in the 6MWD test; worsening of WHO functional class. | Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication. | Posted | Number | Participants | From baseline to week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Deaths Per Study Phase for Riociguat Group | In the main study treatment phase participants received Riociguat until 26 weeks. This phase was followed by a long-term extension (LTE) phase, during which participants continued with Riociguat treatment. At the time of study termination, all treated participants were taken off study drug and started the safety follow-up phase, regardless of whether they were in the main phase or in the LTE. | Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication. | Posted | Number | Participants | From start of treatment to end of study |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Deaths Per Study Phase for Placebo Group | In the main study treatment phase participants received Placebo until 26 weeks. This phase was followed by a long-term extension (LTE) phase, during which participants were treated with Riociguat. At the time of study termination, all treated participants were taken off study drug and started the safety follow-up phase, regardless of whether they were in the main phase or in the LTE. | Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication. | Posted | Number | Participants | From start of treatment to end of study |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Serious Adverse Events During Safety Follow-up Phase | At the time of study termination, all participants entered safety follow-up phase regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days. | Safety analysis set: participants randomized and received at least one dose of study medication. | Posted | Number | Participants | From start of safety follow-up phase until end of study |
|
Treatment emergent Adverse Events are reported: from start of study treatment up to 7 days after end of treatment.
Participants in Placebo group were transitioned to Riociguat treatment in LTE phase.
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 up to 2.5 mg Tid | Reporting group 1 (RG 1): All participants randomized to Riociguat treatment in Main study treatment phase (data until week 26); participants received Riociguat titrated to optimal dose within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. Note: safety data presented here include participants in Riociguat Arm of Period 1 in Participant Flow section. | 27 | 73 | 54 | 73 | ||
| EG001 | Placebo | Reporting group 2 (RG 2): All participants randomized to Placebo treatment in Main study treatment phase (data until week 26); participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. Note: safety data presented here include participants in Placebo Arm of Period 1 in Participant Flow section. | 17 | 74 | 52 | 74 | ||
| EG002 | Riociguat-Riociguat Transition | Reporting group 3 (RG 3): All participants that were initially randomized to Riociguat treatment in Main study treatment phase and later entered Long-term extension (LTE) phase (data starting from week 26 to study termination); participants received a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until the study was terminated. Note: safety data presented here include participants in Riociguat Arm of Period 2 in Participant Flow section. | 12 | 32 | 26 | 32 | ||
| EG003 | Placebo-Riociguat Transition | Reporting group 4 (RG 4): All participants that were initially randomized to Placebo treatment in Main study treatment phase and later entered LTE phase (data starting from week 26 to study termination); participants received a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until the study was terminated. Note: safety data presented here include participants in Placebo Arm of Period 2 in Participant Flow section. | 21 | 38 | 32 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Choroidal neovascularisation | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonia moraxella | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bone abscess | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bladder papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cerebral artery thrombosis | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute interstitial pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Inguinal hernia repair | Surgical and medical procedures | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lung transplant | Surgical and medical procedures | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right ventricular failure | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Catheterisation cardiac | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
|
The study was prematurely terminated following a recommendation from the independent Data Monitoring Committee, as patients receiving Riociguat showed an increased risk of mortality and serious adverse events as compared to patients receiving Placebo
Written consent must be obtained from Bayer prior to any information being submitted for publication. Material proposed for publication or presentation must be provided to Bayer prior to submission. All reasonable comments made by the Sponsor in relation to a proposed publication by the Investigator will be incorporated by the Investigator into the publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayer.com |
| ID | Term |
|---|---|
| D054988 | Idiopathic Interstitial Pneumonias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542595 | riociguat |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| clinic worsening |
|
| withdrawal by PI |
|
| logistical difficulties |
|
| progressive disease |
|
| too unwell to attend the visit |
|
| treatment unblinded |
|
| withdrawn due to lung transplant |
|
| Title | Measurements |
|---|---|
|
| >=75 years |
|
| Male |
|
| Other |
|
| Idiopathic nonspecific interstitial pneumonia |
|
| Resp. bronchiolitis-interstitial lung disease |
|
| Cryptogenic organizing pneumonia |
|
| Acute interstitial pneumonia |
|
| Idiopathic lymphoid interstitial pneumonia |
|
| Unclassifiable idiopathic interstitial pneumonias |
|
| Class III |
|
| Class IV |
|
| >= 320 m and <380m |
|
| >= 380 m |
|
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|