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The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.
The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil ≥20mg three times daily | Subjects receiving sildenafil ≥20mg three times daily for the treatment of PAH |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil citrate | Drug | Sildenafil citrate, 20mg oral tablets, taken at least three times daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline, Year 1 |
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline, Year 2 |
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline, Year 3 |
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Baseline, Year 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4 | NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at least 18 years of age diagnosed with pulmonary arterial hypertension (PAH; per Dana Point classification) and treated with sildenafil citrate for their PAH
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany | |||
| Mater Misericordiae Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil | Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline, Year 1, 2, 3, 4 |
| Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4 | RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. | Baseline, Year 1, 2, 3, 4 |
| Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4 | mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. | Baseline, Year 1, 2, 3, 4 |
| Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4 | PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm). | Baseline, Year 1, 2, 3, 4 |
| Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4 | CI: calculated as COsys divided by BSA. | Baseline, Year 1, 2, 3, 4 |
| Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4 | PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. | Baseline, Year 1, 2, 3, 4 |
| Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4 | Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum. | Baseline, Year 1, 2, 3, 4 |
| Dublin |
| 7 |
| Ireland |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil | Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | For baseline characteristic gender, number of participants evaluable was 226. | Number | participants |
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| Six-Minute Walk Distance (6MWD) | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Number of participants evaluable for this measure was 176. | Mean | Standard Deviation | meter |
| |||||||||||||||||||||
| New York Heart Association, World Health Organization (NYHA/WHO) Functional Class | NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Number of participants in each functional class was reported. Number of participants evaluable for this measure was 216. | Number | participants |
| ||||||||||||||||||||||
| Right Atrial Pressure (RAP) | RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. Number of participants evaluable for this measure was 50. | Mean | Standard Deviation | millimeters of mercury (mmHg) |
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| Mean Pulmonary Arterial Pressure (mPAP) at rest | mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. Number of participants evaluable for this measure was 56. | Mean | Standard Deviation | mmHg |
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| Pulmonary Vascular Resistance (PVR) | PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm). Number of participants evaluable for this measure was 48. | Mean | Standard Deviation | dynes*second/centimeter^5 |
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| Cardiac Index (CI) | CI: calculated as cardiac output in systemic circulation (COsys) divided by body surface area (BSA). Number of participants evaluable for this measure was 44. | Mean | Standard Deviation | (Liter/minute)/square meter([L/min]/m^2) |
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| Pulmonary Capillary Wedge Pressure (PCWP) | PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. Number of participants evaluable for this measure was 44. | Mean | Standard Deviation | mmHg |
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| Borg Dyspnea Index | Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all; 0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum. Participants evaluable=158. | Mean | Standard Deviation | units on a scale |
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| 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 | Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | meter | Baseline, Year 1 |
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| Primary | Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | meter | Baseline, Year 2 |
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| Primary | Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | meter | Baseline, Year 3 |
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| Primary | Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4 | 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. | Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | meter | Baseline, Year 4 |
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| Secondary | Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4 | NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported. | Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. Here, 'n' included those participants who were evaluable for this measure at specified time points. | Posted | Number | participants | Baseline, Year 1, 2, 3, 4 |
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| Secondary | Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4 | RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. | Data was not summarized because results were available for very few participants and were insufficient for analysis. | Posted | Baseline, Year 1, 2, 3, 4 |
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| Secondary | Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4 | mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. | Data was not summarized because results were available for very few participants and were insufficient for analysis. | Posted | Baseline, Year 1, 2, 3, 4 |
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| Secondary | Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4 | PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm). | Data was not summarized because results were available for very few participants and were insufficient for analysis. | Posted | Baseline, Year 1, 2, 3, 4 |
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| Secondary | Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4 | CI: calculated as COsys divided by BSA. | Data was not summarized because results were available for very few participants and were insufficient for analysis. | Posted | Baseline, Year 1, 2, 3, 4 |
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| Secondary | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4 | PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. | Data was not summarized because results were available for very few participants and were insufficient for analysis. | Posted | Baseline, Year 1, 2, 3, 4 |
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| Secondary | Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4 | Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum. | Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Year 1, 2, 3, 4 |
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Only those adverse events that were determined to be related to sildenafil by the investigator were reported in this observational retrospective 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 | Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years. | 0 | 227 | 11 | 227 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle oedema, facial flushing | General disorders | No coding system | Non-systematic Assessment |
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| Back pain or dizziness or eyesight | General disorders | No coding system | Non-systematic Assessment |
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| Cough | General disorders | No coding system | Non-systematic Assessment |
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| Dizziness | General disorders | No coding system | Non-systematic Assessment |
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| Gastro-intestinal symptoms | General disorders | No coding system | Non-systematic Assessment |
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| Head fuzzy/mild headache/mild flushing/mild nasal congestion | General disorders | No coding system | Non-systematic Assessment |
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| Headache, diarrhoea and anxiety | General disorders | No coding system | Non-systematic Assessment |
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| Mild headache/increased heart rate | General disorders | No coding system | Non-systematic Assessment |
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| Nasal stuffiness/headache | General disorders | No coding system | Non-systematic Assessment |
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| Nose bleeds | General disorders | No coding system | Non-systematic Assessment |
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| Rash/itch (severe) | General disorders | No coding system | Non-systematic Assessment |
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| Red face/peripheral oedema | General disorders | No coding system | Non-systematic Assessment |
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| Vague upper abdominal discomfort by suspected pancreatic cancer | General disorders | No coding system | Non-systematic Assessment |
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| Worsening of PAH | General disorders | No coding system | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.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 |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Class III |
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| Class IV |
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