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Terminated due to slow enrollment
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The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will also examine whether patients on sildenafil can reduce the number of iloprost inhalations from the approved 6 doses per day to 4 doses per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DB inhaled iloprost 6x/day | Experimental | inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period |
|
| DB inhaled iloprost 4x/day | Experimental | Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period |
|
| DB inhaled placebo 6x/day | Placebo Comparator | Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period |
|
| OL inhaled iloprost 6x/day | Experimental | Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period |
|
| OL inhaled iloprost 4x/day | Experimental | Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Iloprost (5 μg) | Drug | iloprost inhalation solution (Ventavis) (5 μg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period | The 6MWD test is a non-encouraged test, performed in a 30-meter long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones during 6 minutes. They can slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline. | Day 1 and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16 | This test is used to assess disease severity. Four fucntional classes (FC) are defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). Improvement is considered when a participant changes from a higher class to a lower class. | Day 1 and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Events | This is the overall number of participants in each group who reported at least one adverse event (i.e., any untoward medical occurrence or unfavorable and unintended sign whether or not considered related to the study drug) with an onset from the first administration of study drug up to the last study visit. | From Day 1 to Week 16 and Week 48 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nazzareno Galie, MD | Istituto Malattie Apparato Cardio Univ di Bologna | Principal Investigator |
Not provided
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| Label | URL |
|---|---|
| CoTherix Clinical Development | View source |
Not provided
Not provided
Due to slow participant enrollment, the study was prematurely terminated, and recruitment was stopped after 67 subjects had been recruited instead of 180 initially planned (37% of the originally-planned sample size)
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| ID | Title | Description |
|---|---|---|
| FG000 | DB Iloprost 6×/Day | Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan |
| FG001 | DB Iloprost 4×/Day | Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan |
| FG002 | DB Placebo 6×/Day | Inhaled placebo 6×/day plus sildenafil with or without bosentan |
| FG003 | OL Iloprost 6x/Day | The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period |
| FG004 | OL Inhaled Iloprost 4x/Day | Subjects in this group received inhaled iloprost (5μg) 4x/day plus sildenafil with or without bosentan during the open-label period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double Blind Period (New Patients) |
|
| ||||||||||||||||||
| Open Label-Patients From Double-Blind |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | DB Iloprost 6×/Day | Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan |
| BG001 | DB Iloprost 4×/Day | Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period | The 6MWD test is a non-encouraged test, performed in a 30-meter long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones during 6 minutes. They can slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline. | Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had at least one post-baseline efficacy measure at Week 16. Due to early study termination (about 30% of the enrollment goal) the study was severely under-powered and no accurate statistical analyses could be performed. | Posted | Mean | Standard Deviation | Meters | Day 1 and Week 16 |
|
from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DB Iloprost 6×/Day | Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
Primary purpose was to evaluate the efficacy of iloprost in PAH patients. Due to slow recruitment only 67 of the 180 participants planned were enrolled. Consequently efficacy results are not meaningful and no statistical analyses could be performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Palmer SVP, US Medical Affairs | Actelion Pharmaceuticals US, Inc. | 650-624-6900 |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D000077300 | Bosentan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
Not provided
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Not provided
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Not provided
Not provided
|
| Inhaled Placebo | Drug | inhaled placebo |
|
| Sildenafil | Drug | oral sildenafil (dosage between 60 and 300 mg/day) |
|
| Bosentan | Drug | oral bosentan (dosage between 62.5 and 125 mg BID) |
|
| Time to Clinical Worsening | Clinical worsening is defined as one of the following: death due to worsening PAH, receipt of lung or heart-lung transplantation, or atrial septostomy, hospitalization for worsening PAH, any early discontinuation from study during the blinded or open-label phase due to worsening PAH, initiation of additional PAH-specific treatment. Due to insufficient data, time could not be assessed accurately and only number of patients with clinical worsening could be reported. | Week 16 and Week 48 |
| Adverse Event |
|
| Investigator's judgement |
|
| Disease progression |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | DB Placebo 6×/Day | Inhaled placebo 6×/day plus sildenafil with or without bosentan |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan |
| OG001 | DB Iloprost 4×/Day | Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan |
| OG002 | DB Placebo 6×/Day | Inhaled placebo 6×/day plus sildenafil with or without bosentan |
|
|
| Secondary | Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16 | This test is used to assess disease severity. Four fucntional classes (FC) are defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). Improvement is considered when a participant changes from a higher class to a lower class. | Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had at least one post-baseline efficacy measure at Week 16. Due to early study termination (about 30% of the enrollment goal) the study was severely under-powered and no accurate statistical analyses could be performed. | Posted | Count of Participants | Participants | Day 1 and Week 16 |
|
|
|
| Secondary | Time to Clinical Worsening | Clinical worsening is defined as one of the following: death due to worsening PAH, receipt of lung or heart-lung transplantation, or atrial septostomy, hospitalization for worsening PAH, any early discontinuation from study during the blinded or open-label phase due to worsening PAH, initiation of additional PAH-specific treatment. Due to insufficient data, time could not be assessed accurately and only number of patients with clinical worsening could be reported. | Only participants who received at least one dose of study drug and with available data at Week 16 (for the double-blind period) and at Week 48 (for the open-label period) were included in the analysis | Posted | Count of Participants | Participants | Week 16 and Week 48 |
|
|
|
| Other Pre-specified | Number of Participants With Any Adverse Events | This is the overall number of participants in each group who reported at least one adverse event (i.e., any untoward medical occurrence or unfavorable and unintended sign whether or not considered related to the study drug) with an onset from the first administration of study drug up to the last study visit. | Safety population: All randomiized subjects who received at least one dose of the study drug | Posted | Count of Participants | Participants | From Day 1 to Week 16 and Week 48 |
|
|
|
| Post-Hoc | Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) During the Double-blind Period | The number of participants in the double-blind treatment period who showed improvement or worsening in the 6-MWT - from baseline distance between 100-450 meters - was assessed for each treatment group. The 6-minute walks were measured in meters. Any increase in walk distance at Week 16 was considered improvement from baseline, any decrease was considered as deterioration from baseline. | Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had a post-baseline efficacy measure at Week 16. | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| 3 |
| 26 |
| 24 |
| 26 |
| EG001 | DB Iloprost 4×/Day | Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan | 5 | 27 | 22 | 27 |
| EG002 | DB Placebo 6×/Day | Inhaled placebo 6×/day plus sildenafil with or without bosentan | 3 | 14 | 14 | 14 |
| EG003 | OL Iloprost 6x/Day | The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period | 4 | 26 | 23 | 26 |
| EG004 | OL Iloprost 4x/Day | The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period | 13 | 32 | 30 | 32 |
| Right ventricular failure | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Lupus vasculitis | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Lymph gland infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasal sinus cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dyssomnia | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dysuria | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Penile oedema | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Inguinal hernia | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| Medical device implantation | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| Cardiovascular insufficiency | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Written permission to publish results must be obtained in advance from Actelion (formerly CoTherix). Manuscript of any proposed publication must be sent to Actelion at least 30 days in advance of the submission date. Actelion will inform in writing of any objection of specific content in the proposed publication.In addition, the institution shall either delete disclosure of all potentially patentable inventions or delay submission of the proposed publication for up to 90 days.
| D002318 |
| Cardiovascular Diseases |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000096926 | Benzenesulfonamides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011743 | Pyrimidines |
| No change |
|