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| Name | Class |
|---|---|
| Chiltern International Ltd. | INDUSTRY |
| Effi-Stat | OTHER |
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This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Single arm, open-label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoprostenol | Drug | Administered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events | On average 2.72 years |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure Duration | Duration of exposure to EFI | On average 2.72 years |
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Inclusion Criteria:
Exclusion Criteria:
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Extension study for patients who completed EPITOME-2 (AC-066A301). Patients continued to receive EFI (epoprostenol sodium). In 6 countries (FR, CA, BE, NL, IT, ES) at 8 expert centers for the treatment of patients with pulmonary arterial hypertension. Recruitment started on 15 June 2011 and was completed on 02 February 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | All patients who received at least one dose of EFI |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | All patients who received at least one dose of EFI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Treatment-emergent Adverse Events | All patients who received at least one dose of EFI | Posted | Number | Number of patients | On average 2.72 years |
|
|
On average 2.72 years
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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 | Treatment | All patients who received at least one dose of EFI |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Pfister, PhD | Actelion Pharmaceuticals Ltd | thomas.pfister@actelion.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011464 | Epoprostenol |
| ID | Term |
|---|---|
| D044062 | Prostaglandins I |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Patient's and investigator's decision |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Exposure Duration | Duration of exposure to EFI | Posted | Median | Full Range | year | On average 2.72 years |
|
|
|
| 35 |
| 41 |
| 39 |
| 41 |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lung transplant | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device alarm issue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device damage | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device leakage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment | Not local infection, not sepsis |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Transplant evaluation | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis moraxella | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Cardiac flutter | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Device breakage | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Device connection issue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Infusion site vesicles | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Medical device change | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
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| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pneumonia primary atypical | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Shock haemorrhagic | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Sinus arrhythmia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
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| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |