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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003572-21 | EudraCT Number |
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See termination reason in detailed description.
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Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)
Pfizer decided to stop this trial early upon Stage 1 completion due to change in PF-00489791 development and not as a result of safety concerns for PF-00489791. Date of termination (LSLV) occurred on July 28, 2010.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-00489791 1 mg | Experimental |
| |
| PF-00489791 2 mg | Experimental |
| |
| PF-00489791 4 mg | Experimental |
| |
| PF-00489791 10 mg | Experimental |
| |
| PF-00489791 20 mg | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Sildenafil | Active Comparator | Observational comparator arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00489791 | Drug | tablet form, 1 mg, single dose (Day 1) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) Over 4 Hours Post Dose | PVRI was calculated as: PVRI (in Wood units*meter^2 [m^2]) = pulmonary vascular resistance (PVR) multiplied by body surface area (BSA). PVR (in Wood units) = (mean pulmonary artery pressure [mean PAP] minus pulmonary capillary wedge pressure [PCWP]) divided by cardiac output (CO, taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in centimeters [cm])^0.725 multiplied by (weight in kilograms [kg])^0.425. PVRI values were converted to dyne*second (s)*m^2/centimeter (cm)^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in PVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1. | Baseline, up to 4 hours post-dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Greatest Reduction From Baseline in Pulmonary Vascular Resistance Index (PVRI) and Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose | PVRI was calculated as: PVRI (in Wood units*m^2) = PVR multiplied by BSA. PVR (in Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVRI was calculated as: SVRI (Wood units*m^2) = systemic vascular resistance (SVR) multiplied by BSA. SVR (Wood units) = (mean systemic arterial pressure [mean SAP] minus right atrial pressure [RAP]) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. PVRI and SVRI values were converted to dyne*s*m^2/cm^5 from Woods units by multiplying by a factor of 79.9. For each participant the greatest reduction (GR) from baseline in PVRI and SVRI over 4-hour interval was defined as the maximum reduction (greatest decrease or smallest increase) observed at 1, 2, 3, and 4 hours post dose on Day 1. |
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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 |
|---|---|---|---|---|---|---|
| Pulmonary Associates, PA | Phoenix | Arizona | 85006 | United States | ||
| John C. Lincoln Hospital, North Mountain |
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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 | Placebo | Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1. |
| FG001 | PF-00489791 1 mg | Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PF-00489791 |
| Drug |
tablet form, 2 mg, single dose (Day 1) |
|
| PF-00489791 | Drug | tablet form, 4 mg, single dose (Day 1) |
|
| PF-00489791 | Drug | tablet form, 10 mg, single dose (Day 1) |
|
| PF-00489791 | Drug | tablet form, 20 mg, single dose (Day 1) |
|
| placebo | Drug | tablet form, single dose (Day 1) |
|
| sildenafil | Drug | tablet form, 20 mg, single dose (Day 1) |
|
|
| Baseline, up to 4 hours post-dose on Day 1 |
| Mean Change From Baseline in Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose | SVRI was calculated as: SVRI (Wood units*m^2) = SVR multiplied by BSA. SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. SVRI values were converted to dyne*s*m^2/cm^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in SVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1. | Baseline, up to 4 hours post-dose on Day 1 |
| Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose | PVRI was calculated as: PVR multiplied by BSA. PVR = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = 0.007184 times height (cm)^0.725 times weight (kilogram)^0.425. Wood unit equals to 79.9 dyne*second/cm^5. Hourly changes from baseline in PVRI was reported. | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
| Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose | SVRI is the product of SVR and BSA. SVR equals to (mean SAP subtracted by RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) equals to 0.007184 times height (cm)^0.725 times weight (kilogram) ^0.425. Wood unit equals to 79.9 dyne*second/cm^5. Hourly changes from baseline in SVRI was reported. | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
| Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose | CI was calculated as: CI (liters per minute per square meter [L/min/m^2]) = CO (taken as the average of the triplicate measurements) divided by BSA. BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
| Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose | Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including mPAP, sPAP, dPAP and RAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements were performed as triplicate measurements and average was used. | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
| Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose | Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including PCWP, SAP, sSAP and dSAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements (except PCWP for which 1 measurement is sufficient) were performed as triplicate measurements and average was used. | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
| Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose | Hourly changes from baseline in PVR and SVR were reported. PVR was calculated by: PVR (Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements). | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
| Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose | Hourly changes from baseline in HR were reported. | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
| Number of Participants With Clinically Significant Laboratory Values | Criteria for clinically significant laboratory values:hemoglobin, hematocrit and red blood cells(less than[<]0.8*lower limit of normal[LLN]); leucocytes (<0.6*LLN/greater than[>]1.5*upper limit of normal[ULN]);platelets (<0.5*LLN></0>1.75* ULN);neutrophils, lymphocytes(<0.8*LLN></0>1.2* ULN); eosinophils, basophils, monocytes (>1.2*ULN);bilirubin (>1.5*ULN);aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(>3*ULN);creatinine, blood urea nitrogen (>1.3*ULN);glucose(<0.6*LLN></0>1.5* ULN); uric acid(>1.2*ULN);sodium(<0.95*LLN></0>1.05*ULN); potassium, chloride, calcium(<0.9*LLN></0>1.1* ULN); albumin, total protein(<0.8></0>1.2* ULN); creatine kinase(>2.0*ULN);urine red blood cells(RBCs), urine white blood cells(WBCs)(>=6 per high-powered field);qualitative urine glucose, urine ketones, urine protein, urine blood/hemoglobin(>=1); urine bacteria(>20 per high-powered field); pregnancy test, urine protein, quantitative random serum pregnancy test (>=1). | Baseline up-to follow up (Day 3 to 5) |
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Values | Criteria for clinically significant changes (changes of potential clinical concern) in ECG parameters: increase from baseline of >=30 to <60 milliseconds (msec) or >=60 msec in corrected QT interval (QTc), QT interval corrected using Fridericia's correction (QTcF) and QT interval corrected using Bazett's correction (QTcB); Increase from baseline of >= 25% (when baseline was >200 msec) or increase from baseline of >=50% (when baseline was <=200 msec) in PR interval; and Increase from baseline of >= 25% (when baseline was >100 msec) or increase from baseline of >=50% (when baseline was <=100 msec) in QRS interval. Number of participants with any clinically significant change in ECG values were reported. | Baseline up-to follow up (Day 3 to 5) |
| Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose | Arterial blood samples for PaO2 and PaCO2 collected via an arterial line were assessed. PaO2 is the measure of oxygen level in the arterial blood and PaCO2 is the measure of carbon dioxide level in the arterial blood. | Baseline; 1, 4 hours post-dose on Day 1 |
| Plasma Concentration of PF-00489791 and Sildenafil | 1, 2, 3, 4, 5, 6, 8 hours post-dose on Day 1, follow up (Day 3 to 5) |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Pulmonary Associates, PA | Phoenix | Arizona | 85020 | United States |
| Shands at University of Florida | Gainesville | Florida | 32610 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UT Southwestern Medical Center - Department of Internal Medicine Pulmonary | Dallas | Texas | 75390 | United States |
| UT Southwestern St. Paul Hospital | Dallas | Texas | 75390 | United States |
| Lawson Health Research Institute | London | Ontario | N6A 4G5 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Sir Mortimer B. Davis, Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Thoraxklinik am Universitaetsklinikum | Heidelberg | 69126 | Germany |
| Department Of Cardiology, MediCiti Hospital, | Hyderabad | Andhra Pardesh | 500 063 | India |
| Department Of Cardiology, Sri Venkateswara Institute Of Medical Sciences | Tirupati | Andhra Pardesh | 517 507 | India |
| Bankers Heart Institute | Vadodara | Gujarat | 390 015 | India |
| Omega Hospital | Mangalore | Karnataka | 575 002 | India |
| Moscow Healthcare Institution "City Clinical Hospital No. 57" | Moscow | 105077 | Russia |
| Institute of Cardiosurgery n.a. V.I.Burakovsky | Moscow | 121552 | Russia |
| Hospital General Universitari Vall D´Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Universitetssjukhuset i Lund, Hjart- och Lungdivisionen | Lund | 221 85 | Sweden |
| Norrlands Universitetssjukhus, Kliniskt Forsknings Centrum | Umeå | 901 85 | Sweden |
| Akademiska Sjukhuset, Kardiologen 50F/Forskningsenheten | Uppsala | 751 85 | Sweden |
| Universitaetsspittal Zuerich, Medizinische Klinik A | Zurich | CH-8091 | Switzerland |
| FG002 | PF-00489791 2 mg | Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| FG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| FG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| FG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| FG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all randomized participants who received study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1. |
| BG001 | PF-00489791 1 mg | Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| BG002 | PF-00489791 2 mg | Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| BG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| BG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| BG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| BG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
| BG007 | Total | Total of all reporting groups |
| 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, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) Over 4 Hours Post Dose | PVRI was calculated as: PVRI (in Wood units*meter^2 [m^2]) = pulmonary vascular resistance (PVR) multiplied by body surface area (BSA). PVR (in Wood units) = (mean pulmonary artery pressure [mean PAP] minus pulmonary capillary wedge pressure [PCWP]) divided by cardiac output (CO, taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in centimeters [cm])^0.725 multiplied by (weight in kilograms [kg])^0.425. PVRI values were converted to dyne*second (s)*m^2/centimeter (cm)^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in PVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1. | Full analysis set (FAS) included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group. | Posted | Mean | Standard Deviation | (dyne*s*m^2)/cm^5 | Baseline, up to 4 hours post-dose on Day 1 |
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| Secondary | Greatest Reduction From Baseline in Pulmonary Vascular Resistance Index (PVRI) and Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose | PVRI was calculated as: PVRI (in Wood units*m^2) = PVR multiplied by BSA. PVR (in Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVRI was calculated as: SVRI (Wood units*m^2) = systemic vascular resistance (SVR) multiplied by BSA. SVR (Wood units) = (mean systemic arterial pressure [mean SAP] minus right atrial pressure [RAP]) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. PVRI and SVRI values were converted to dyne*s*m^2/cm^5 from Woods units by multiplying by a factor of 79.9. For each participant the greatest reduction (GR) from baseline in PVRI and SVRI over 4-hour interval was defined as the maximum reduction (greatest decrease or smallest increase) observed at 1, 2, 3, and 4 hours post dose on Day 1. | Full analysis set (FAS) included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group. | Posted | Mean | Standard Deviation | (dyne*s*m^2)/cm^5 | Baseline, up to 4 hours post-dose on Day 1 |
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| Secondary | Mean Change From Baseline in Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose | SVRI was calculated as: SVRI (Wood units*m^2) = SVR multiplied by BSA. SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. SVRI values were converted to dyne*s*m^2/cm^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in SVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1. | FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure. | Posted | Mean | Standard Deviation | (dyne*s*m^2)/cm^5 | Baseline, up to 4 hours post-dose on Day 1 |
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| Secondary | Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose | PVRI was calculated as: PVR multiplied by BSA. PVR = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = 0.007184 times height (cm)^0.725 times weight (kilogram)^0.425. Wood unit equals to 79.9 dyne*second/cm^5. Hourly changes from baseline in PVRI was reported. | FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group. | Posted | Mean | Standard Deviation | (dyne*s*m^2)/cm^5 | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
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| Secondary | Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose | SVRI is the product of SVR and BSA. SVR equals to (mean SAP subtracted by RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) equals to 0.007184 times height (cm)^0.725 times weight (kilogram) ^0.425. Wood unit equals to 79.9 dyne*second/cm^5. Hourly changes from baseline in SVRI was reported. | FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group. | Posted | Mean | Standard Deviation | (dyne*s*m^2)/cm^5 | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
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| Secondary | Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose | CI was calculated as: CI (liters per minute per square meter [L/min/m^2]) = CO (taken as the average of the triplicate measurements) divided by BSA. BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. | FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group. | Posted | Mean | Standard Deviation | L/min/m^2 | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
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| Secondary | Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose | Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including mPAP, sPAP, dPAP and RAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements were performed as triplicate measurements and average was used. | FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
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| Secondary | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose | Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including PCWP, SAP, sSAP and dSAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements (except PCWP for which 1 measurement is sufficient) were performed as triplicate measurements and average was used. | FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group. | Posted | Mean | Standard Deviation | mmHg | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
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| Secondary | Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose | Hourly changes from baseline in PVR and SVR were reported. PVR was calculated by: PVR (Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements). | FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group. | Posted | Mean | Standard Deviation | Wood units | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
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| Secondary | Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose | Hourly changes from baseline in HR were reported. | FAS included all randomized participants who received study medication. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline, 1, 2, 3, 4 hours post-dose on Day 1 |
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| Secondary | Number of Participants With Clinically Significant Laboratory Values | Criteria for clinically significant laboratory values:hemoglobin, hematocrit and red blood cells(less than[<]0.8*lower limit of normal[LLN]); leucocytes (<0.6*LLN/greater than[>]1.5*upper limit of normal[ULN]);platelets (<0.5*LLN></0>1.75* ULN);neutrophils, lymphocytes(<0.8*LLN></0>1.2* ULN); eosinophils, basophils, monocytes (>1.2*ULN);bilirubin (>1.5*ULN);aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(>3*ULN);creatinine, blood urea nitrogen (>1.3*ULN);glucose(<0.6*LLN></0>1.5* ULN); uric acid(>1.2*ULN);sodium(<0.95*LLN></0>1.05*ULN); potassium, chloride, calcium(<0.9*LLN></0>1.1* ULN); albumin, total protein(<0.8></0>1.2* ULN); creatine kinase(>2.0*ULN);urine red blood cells(RBCs), urine white blood cells(WBCs)(>=6 per high-powered field);qualitative urine glucose, urine ketones, urine protein, urine blood/hemoglobin(>=1); urine bacteria(>20 per high-powered field); pregnancy test, urine protein, quantitative random serum pregnancy test (>=1). | Safety analysis set included all randomized participants who received study medication. | Posted | Count of Participants | Participants | Baseline up-to follow up (Day 3 to 5) |
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| Secondary | Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Values | Criteria for clinically significant changes (changes of potential clinical concern) in ECG parameters: increase from baseline of >=30 to <60 milliseconds (msec) or >=60 msec in corrected QT interval (QTc), QT interval corrected using Fridericia's correction (QTcF) and QT interval corrected using Bazett's correction (QTcB); Increase from baseline of >= 25% (when baseline was >200 msec) or increase from baseline of >=50% (when baseline was <=200 msec) in PR interval; and Increase from baseline of >= 25% (when baseline was >100 msec) or increase from baseline of >=50% (when baseline was <=100 msec) in QRS interval. Number of participants with any clinically significant change in ECG values were reported. | Safety analysis set included all randomized participants who received study medication. | Posted | Count of Participants | Participants | Baseline up-to follow up (Day 3 to 5) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose | Arterial blood samples for PaO2 and PaCO2 collected via an arterial line were assessed. PaO2 is the measure of oxygen level in the arterial blood and PaCO2 is the measure of carbon dioxide level in the arterial blood. | Safety analysis set included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group. | Posted | Mean | Standard Deviation | mmHg | Baseline; 1, 4 hours post-dose on Day 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of PF-00489791 and Sildenafil | Data was not reported for this outcome measure because the study was terminated and as per change in planned analysis, the pharmacokinetic parameters were not to be summarized. | Posted | 1, 2, 3, 4, 5, 6, 8 hours post-dose on Day 1, follow up (Day 3 to 5) |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1. | 2 | 6 | 2 | 6 | ||
| EG001 | PF-00489791 1 mg | Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. | 0 | 6 | 4 | 6 | ||
| EG002 | PF-00489791 2 mg | Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. | 0 | 7 | 2 | 7 | ||
| EG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. | 0 | 6 | 5 | 6 | ||
| EG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. | 0 | 6 | 4 | 6 | ||
| EG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. | 1 | 7 | 2 | 7 | ||
| EG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. | 0 | 6 | 3 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Vulval cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v13.0 | Non-systematic Assessment | This was a gender specific event. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Urinary sediment present | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v13.0 | Non-systematic Assessment |
|
Study was terminated prematurely as further continuation would not have meaningfully contributed to the next phase of development.
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 |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000619499 | PF-00489791 |
| 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 |
Not provided
Not provided
| Between 45 and 64 Years |
|
| Greater than or equal to (>=) 65 Years |
|
| Male |
|
|
| Change over 4 hours post-dose |
|
|
| Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of >=240 dyne.s.m2/cm5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis. | Bayesian 4-parameter Emax model. | 0.250 | Predicted Mean Difference | -170.6 | Standard Deviation | 107.84 | 2-Sided | 95 | -409.2 | -7.1 | Superiority or Other |
| The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of >=240 dyne*s*m^2/cm^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis. | Bayesian 4-parameter Emax model. | 0.485 | Predicted Mean Difference | -240.2 | Standard Deviation | 109.28 | 2-Sided | 95 | -444.8 | -33.8 | Superiority or Other |
| Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of >=240 dyne*s*m^2/cm^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis. | Bayesian 4-parameter Emax model. | 0.810 | Predicted Mean Difference | -327.9 | Standard Deviation | 92.41 | 2-Sided | 95 | -492.9 | -148.0 | Superiority or Other |
| Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. Posterior distribution was calculated and was used to calculate a probability (presented as p value) that the dose gives a difference of >=240 dyne*s*m^2/cm^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis. | Bayesian 4-parameter Emax model | 0.974 | Predicted Mean Difference | -379.4 | Standard Deviation | 73.61 | 2-Sided | 95 | -520.6 | -238.8 | Superiority or Other |
| PF-00489791 1 mg |
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG002 | PF-00489791 2 mg | Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
|
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
|
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
|
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
|
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
|
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
|
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
| OG002 | PF-00489791 2 mg | Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
| PF-00489791 2 mg |
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
| OG003 | PF-00489791 4 mg | Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
|
|
| OG004 | PF-00489791 10 mg | Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1. |
| OG005 | PF-00489791 20 mg | Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1. |
| OG006 | Sildenafil | Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1. |
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