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The purpose of this study is to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study for the treatment of PAH in Poland. Only safety and tolerability data will be collected in these patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil | Drug | tablets, 20mg, TID, 112 weeks at the maximum | ||
| sildenafil | Drug | tablets, 20mg x 4 (80mg), TID, approximately 70 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. | Baseline up to 116 Weeks |
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Inclusion Criteria:
Subjects aged 18 and over who have any of the following conditions:
Subjects with a mean pulmonary artery pressure (mPAP) > 25mmHg and a pulmonary artery wedge pressure (PAWP) < 15mmHg at rest, assessed via right heart catheterization.
Subjects whose baseline 6-min walk test distance was > 100m and < 450m.
Exclusion Criteria:
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Expanded access
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Warsaw | 01-138 | Poland | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil 60 mg | Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension) |
| FG001 | Sildenafil 240 mg | Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil 60 mg | Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension) |
| BG001 | Sildenafil 240 mg | Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect. | Safety population: all subjects assumed to have taken at least one dose of study medication. Non-serious adverse events were reported up to 7 days after the last dose of study medication. Serious adverse events were reported up to 28 days after the last dose of study medication. | Posted | Number | participants | Baseline up to 116 Weeks |
|
Serious Advserse Events: Baseline up to 28 days after last dose of study medication; Non-serious Adverse Events: Baseline up to 7 days after last dose of study medication
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during 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 | Sildenafil 60 mg | Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Zabrze |
| 41-800 |
| Poland |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Sildenafil 60 mg |
Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension) |
| OG001 | Sildenafil 240 mg | Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142 |
|
|
| 8 |
| 20 |
| 11 |
| 20 |
| EG001 | Sildenafil 240 mg | Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142 | 2 | 12 | 8 | 12 |
| Cardiac failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Retinal vein thrombosis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Connective tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mixed connective tissue disease | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
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| 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 |