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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-070381 |
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To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sildenafil citrate (UK-92,480) | Experimental | sildenafil citrate 20 mg TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil citrate (UK-92,480) | Drug | sildenafil citrate (UK-92,480) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test. | Baseline, Week 12 |
| Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline. | Baseline, Week 12 |
| Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline | Baseline, Week 12 |
| Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Cardiac output at Week 12 minus cardiac output at baseline | Baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I | Change：6-minute walk distance at Week 8 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test. | Baseline, Week 8 |
| Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Chiba | Chiba | Japan | |||
| 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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Twenty-one pulmonary arterial hypertension patients who have never received sildenafil therapy entered the study from Part I period and could continue to study part II period. Twenty-three patients who were continuously using sildenafil entered the study from Part II period.
Eight centers in Japan
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil: Participant Who Entered the Study From Part I | Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension). |
| FG001 | Sildenafil: Participants Who Entered the Study From Part II | Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil: Participant Who Entered the Study From Part I | Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension). |
| 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 | Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | meters | Baseline, Week 12 |
|
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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: Part I and Part II | Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal 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.govCallCenter@pfizer.com |
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| 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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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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Change：Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline. |
| Baseline, Week 12 |
| Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline. | Baseline, Week 12 |
| Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline. | Baseline, Week 12 |
| Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline. | Baseline, Week 12 |
| Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3. Change：Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline. | Baseline, Week 12 |
| Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline. | Baseline, Week 12 |
| Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Right atrial pressure at Week 12 minus right atrial pressure at baseline. | Baseline, Week 12 |
| Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Cardiac index at Week 12 minus cardiac index at baseline. | Baseline, Week 12 |
| Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Heart rate at Week 12 minus heart rate at baseline. | Baseline, Week 12 |
| Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline. | Baseline, Week 12 |
| Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline. | Baseline, Week 12 |
| Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline. | baseline, Week 12 |
| Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline. | Baseline, Week 12 |
| Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline. | Baseline, Week 12 |
| Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline. | baseline, Week 12 |
| Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline. | Baseline, Week 12 |
| Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I | The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms). | Baseline, Week 12 |
| Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I | Change：BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance. | Baseline, Week 8, Week 12 |
| Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I | Change：Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline | Baseline, Week 4, Week 8, Week 12 |
| Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II | Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test. | Baseline, Week 12 |
| Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II | The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms). | Baseline, Week 12 |
| Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II | Change：BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance. | Baseline, Week 12 |
| Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II | Change：Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline | Baseline, Week 12 |
| Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 | Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing |
| Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 | Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing |
| The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320 | The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing |
| The Average Plasma Concentration (Css,av) of Sildenafil at Steady State | The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours). | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing |
| The Average Plasma Trough Concentration (Ctrough) of Sildenafil | The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing |
| Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | The total number of participants with laboratory test abnormalities without regard to baseline abnormality. | Baseline up to 1.3 years |
| Kanazawa |
| Ishikawa-ken |
| Japan |
| Pfizer Investigational Site | Tsu | Mie-ken | Japan |
| Pfizer Investigational Site | Okayama | Okayama-ken | Japan |
| Pfizer Investigational Site | Hamamatsu | Shizuoka | Japan |
| Pfizer Investigational Site | Bunkyo-ku | Tokyo | Japan |
| Pfizer Investigational Site | Shinjuku-ku | Tokyo | Japan |
| Pfizer Investigational Site | Tokyo | Japan |
| Protocol Violation |
|
| BG001 | Sildenafil: Participants Who Entered the Study From Part II | Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
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| Primary | Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | dyne·second/centimeter^5 | Baseline, Week 12 |
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| Secondary | Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I | Change：6-minute walk distance at Week 8 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | meters | Baseline, Week 8 |
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| Secondary | Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
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| Secondary | Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
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| Secondary | Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
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| Secondary | Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
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| Secondary | Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3. Change：Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
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| Primary | Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Cardiac output at Week 12 minus cardiac output at baseline | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | liter/minute | Baseline, week 12 |
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| Secondary | Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
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| Secondary | Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Right atrial pressure at Week 12 minus right atrial pressure at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
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| Secondary | Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Cardiac index at Week 12 minus cardiac index at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | liter/minute/meter^2 | Baseline, Week 12 |
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| Secondary | Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Heart rate at Week 12 minus heart rate at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | beats/minute | Baseline, Week 12 |
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| Secondary | Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | dyne*second/centimeter^5/meter^2 | Baseline, Week 12 |
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| Secondary | Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | dyne*second/centimeter^5 | Baseline, Week 12 |
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| Secondary | Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | dyne*second/centimeter^5/meter^2 | baseline, Week 12 |
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| Secondary | Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | percent saturation | Baseline, Week 12 |
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| Secondary | Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | percent saturation | Baseline, Week 12 |
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| Secondary | Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | baseline, Week 12 |
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| Secondary | Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I | Change：Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
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| Secondary | Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I | The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms). | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Number | participants | Baseline, Week 12 |
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| Secondary | Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I | Change：BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12). | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 8, Week 12 |
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| Secondary | Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I | Change：Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12). | Posted | Mean | Standard Deviation | picograms/milliliter | Baseline, Week 4, Week 8, Week 12 |
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| Secondary | Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II | Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | meters | Baseline, Week 12 |
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| Secondary | Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II | The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms). | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Number | participants | Baseline, Week 12 |
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| Secondary | Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II | Change：BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance. | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12 |
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| Secondary | Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II | Change：Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline | Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward. | Posted | Mean | Standard Deviation | picograms/milliliter | Baseline, Week 12 |
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| Secondary | Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 | Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant | Posted | Mean | Standard Deviation | nanograms/milliliter | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing |
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| Secondary | Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 | Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant. | Posted | Mean | Standard Deviation | hours | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing |
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| Secondary | The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320 | The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule | Posted | Mean | Standard Deviation | nanogram*hour/milliliter | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing |
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| Secondary | The Average Plasma Concentration (Css,av) of Sildenafil at Steady State | The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours). | Posted | Mean | Standard Deviation | nanograms/milliliter | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing |
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| Secondary | The Average Plasma Trough Concentration (Ctrough) of Sildenafil | The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants. | Posted | Mean | Standard Deviation | nanograms/milliliter | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing |
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|
|
| Secondary | Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | The total number of participants with laboratory test abnormalities without regard to baseline abnormality. | All subjects who received at least one dose of the study medication and had any evaluable laboratory test data after treatment. | Posted | Number | participants | Baseline up to 1.3 years |
|
|
|
| 7 |
| 44 |
| 42 |
| 44 |
| Cataract | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Scleroderma renal crisis | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Back pain | 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 |
|
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| 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 |
| Functional class at Week 12:III |
|
| Functional class at Week 12:IV |
|
| Title | Measurements |
|---|---|
|
| Functional class at Week 12: III |
|
| Functional class at Week 12: IV |
|