Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil high dose | Experimental | As per Protocol Amendment 8 (Aug 2011), all doses in the high dose treatment group were discontinued. Subjects who were receiving these doses and continued in the study were requested to down titrate. |
|
| Sildenafil Low dose | Experimental |
| |
| Sildenafil medium dose | Experimental | As per Protocol Amendment 8 (August 2011), the dose 40 mg TID in the medium dose treatment group was discontinued. Subjects who were receiving this dose and continued in the study were requested to down titrate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil citrate | Drug | Oral, subjects with body weight ≥8 - 20 kg: 20 mg 3 times a day (tid) subjects with body weight >20 - 45 kg: 40 mg 3 times a day (tid) subjects with body weight >45 kg: 80 mg 3 times a day (tid) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting at Least One Adverse Event | Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the adverse events according to the A1481156 treatment groups are provided in the reported adverse event section. | Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation) |
| Number of Participants Reporting Treatment-related Adverse Events | Safety was measured according to standard adverse event collection as described in the adverse event section of the results. | Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation) |
| Number of Participants Reporting at Least One Serious Adverse Event | Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the serious adverse events according to the A1481156 treatment groups are provided in the reported adverse event section. | Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation) |
| Number of Participants Reporting Treatment-related Serious Adverse Events | All serious adverse events regardless of treatment group or suspected relationship to study drug were reported. Investigators were to provide independent determination of possible causality of any serious adverse event. | Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation) |
| Number of Deaths Reported in the Study Prior to the Data Monitoring Committee (DMC) Recommendation of Dose Down Titration | Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Volume of Oxygen (VO2) Consumed at Year 1 Using a Bicycle Ergometry Cardiopulmonary Exercise Test (CPX) | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the peak volume of VO2 consumed. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Palo Alto | California | 34304 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31908813 | Derived | Russell S, Beghetti M, Oudiz R, Balagtas C, Zhang M, Ivy D. Effects of oral sildenafil on exercise capacity in children with pulmonary arterial hypertension: a randomised trial. Open Heart. 2019 Dec 3;6(2):e001149. doi: 10.1136/openhrt-2019-001149. eCollection 2019. | |
| 31538282 | Derived | Chanu P, Gao X, Bruno R, Claret L, Harnisch L. A modeling and simulation-based assessment of the impact of confounding factors on the readout of a sildenafil survival trial in pulmonary arterial hypertension. J Pharmacokinet Pharmacodyn. 2019 Oct;46(5):499-509. doi: 10.1007/s10928-019-09654-3. Epub 2019 Sep 20. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Participants remained in the same dose group as in study A1481131 (NCT00159913). Participants randomized to placebo in NCT00159913 were rerandomized to sildenafil in A1481156. Placebo participants in low weight category were rerandomized to medium or high dose (1:2) and other weight categories were rerandomized to low, medium or high dose (1:1:1).
This extension study included 220 participants at 31 sites. 14 participants did not go from A1481131 (NCT00159913) to A1481156. Participants from one center in Canada participated in base study A1481131 (NCT00159913) but not in this extension study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil Low/Low Dose | Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156 |
| FG001 | Sildenafil Medium/ Medium Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sildenafil citrate | Drug | Oral,10 mg 3 times a day (tid), only subjects with body weight >20 kg |
|
| Sildenafil citrate | Drug | Oral, subjects with body weight ≥8 - 20 kg: 10 mg 3 times a day (tid); subjects with body weight >20 - 45 kg: 20 mg 3 times a day (tid); subjects with body weight >45 kg: 40 mg 3 times a day (tid) |
|
| Pre-DMC Recommendation dose down titration (04 August 2011) |
| Number of Deaths Reported During This Study | Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later. | Last follow-up visit or 30 days after the last administration of study drug |
| Discontinuation Due to Intolerability | Participant who experienced drug-related intolerance, the participant's dose was reduced by 50%. If, after a dose reduction, the participant continued to appear intolerant, they were discontinued from study treatment. | Throughout the treatment duration (median treatment duration 1689 to 1744 days) |
| Downtitration in Dose Due to Intolerability. | Based on review of the survival data, DMC concluded that the high dose of sildenafil was associated with a harmful effect on survival when compared to the low dose. The DMC also expressed concern as to the potential dose-response relationship between increasing dose and mortality. Therefore, on 04 August 2011, the DMC recommended discontinuation of the 40 mg and 80 mg three times a day (TID) doses, as well as the 20 mg TID dose in children with body weight ≤20 kg. The protocol was amended per DMC recommendations. | Pre-DMC recomendation (04 August 2011) |
| Number of Participants With Deterioration Post Baseline in Visual Acuity Safety Tests | Visual Acuity is measured either using the reduced Snellen test or via Teller cards, and was assessed in the left and right eyes separately. There were 9 lines on the reduced Snellen chart which were coded as 6/60, 6/36, 6/24, 6/18, 6/12, 6/9, 6/6, 6/5, 6/4 (where 6/60 was the easiest to read and 6/4 was the most difficult to read). If a participant experienced a visual adverse event the investigator was asked to perform additional ocular assessments either at the visit when the participant reported the visual adverse event or at an unplanned visit. | Week 36 |
| Number of Participants With Deterioration Post Baseline in Color Vision Monitoring Safety Tests. | Colour vision was measured where appropriate via the Farnsworth-Munsell D-15 Hue test. This test was performed in both eyes simultaneously or just in a single specific eye. If using a single eye the same eye was used throughout the study. In case of young participants an age-and-ability-appropriate evaluation such as the Ishihara Test for Unlettered Persons were conducted. | Week 36 |
| Pediatric Cognitive Development Status at Week 16. | Participant's cognitive development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited. | Week 16 |
| Pediatric Cognitive Development Status at Week 52. | Participant's cognitive development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited. | Week 52 |
| Pediatric Motor Development Status at Week 16. | Participant's motor development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited. | Week 16 |
| Pediatric Motor Development Status at Week 52 | Participant's motor development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited. | Week 52 |
| 1 year |
| Percentage Change From Baseline in Percent Predicted Peak VO2 at Year 1. | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the percent predicted peak VO2 at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | Baseline, Year 1 |
| Percent Change From Baseline in Time to Maximum VO2 at Year 1 | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the time to maximum VO2. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | Baseline, Year 1 |
| Percent Change From Baseline in Respiratory Exchange Ratio at Year 1 | This is the ratio of carbon dioxide (CO2) produced to O2 consumed [VCO2/VO2]. Exercise Tolerance Test was performed on developmentally able participants to determine the respiratory exchange ratio on week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). | Baseline, Year 1 |
| Percent Change From Start of Sildenafil in Total Ventilation (VE) to Year 1 | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the total ventilation. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | Year 1 |
| Percentage Change From Baseline in End Tidal Oxygen (O2) at Year 1. | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal O2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | Baseline, Year 1 |
| Percentage Change From Baseline in End Tidal Carbon Dioxide (CO2) at Year 1. | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal CO2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | Baseline, Year 1 |
| Percentage Change From Baseline in Anaerobic Threshold at Year 1. | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the anaerobic threshold at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | Baseline, Year 1 |
| Summary of Shift in Changes From Start of Sildenafil in World Health Organization Pulmonary Hypertension (WHO PH) Functional Class by A1481156 Treatment Group at Year 1. | The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarized at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated. | Baseline, Year 1 |
| Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 2. | The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated. | Baseline, Year 2 |
| Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 3. | The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 (NCT00159913) baseline at Years 1, 2, 3 and 4 were evaluated. | Baseline, Year 3 |
| Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 4. | The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated. | Baseline, Year 4 |
| Additions From Baseline in Background Therapy up to the End of Study | This was defined as an addition or discontinuation in the class(es) of drugs used as background medication (e.g., anticoagulants, oxygen, diuretics, calcium channel blockers, and digoxin) compared to baseline of Study A1481131 (NCT00159913). | Up to the end of study |
| Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Psychosocial Scale at Year 1. | CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status. | Baseline, Year 1 |
| Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Physical Scale at Year 1. | CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status. | Baseline, Year 1 |
| Participant (Parent) Global Assessment at Year 1 | The participant (parent) global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments. | Year 1 |
| Physician Global Assessment at Year 1 | The physician global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants with markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments. | Year 1 |
| Palo Alto |
| California |
| 94305 |
| United States |
| Pfizer Investigational Site | Stanford | California | 94305 | United States |
| Pfizer Investigational Site | Aurora | Colorado | 80045 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02115 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | New York | New York | 10032 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43205 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29425 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98105 | United States |
| Pfizer Investigational Site | São Paulo | São Paulo | 04012-909 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04023-062 | Brazil |
| Pfizer Investigational Site | Puente Alto | Santiago Metropolitan | Chile |
| Pfizer Investigational Site | MedellÃn | Antioquia | Colombia |
| Pfizer Investigational Site | Bogota | Cundinamarca | Colombia |
| Pfizer Investigational Site | Guatemala City | Guatemala |
| Pfizer Investigational Site | Budapest | 1083 | Hungary |
| Pfizer Investigational Site | Budapest | 1096 | Hungary |
| Pfizer Investigational Site | Szeged | 6720 | Hungary |
| Pfizer Investigational Site | Hyderabad | Andhra Pradesh | 500 001 | India |
| Pfizer Investigational Site | Hyderabad | Andhra Pradesh | 500 073 | India |
| Pfizer Investigational Site | Kochi | Kerala | 682 041 | India |
| Pfizer Investigational Site | Bologna | 40138 | Italy |
| Pfizer Investigational Site | Tokyo | Japan |
| Pfizer Investigational Site | George Town | Pulau Pinang | 10050 | Malaysia |
| Pfizer Investigational Site | George Town | Pulau Pinang | 10900 | Malaysia |
| Pfizer Investigational Site | George Town | Pulau Pinang | 11600 | Malaysia |
| Pfizer Investigational Site | Mexico City | Mexico City | 14080 | Mexico |
| Pfizer Investigational Site | Krakow | 30-663 | Poland |
| Pfizer Investigational Site | Ruda ÅšlÄ…ska | 41-703 | Poland |
| Pfizer Investigational Site | Warsaw | 04-730 | Poland |
| Pfizer Investigational Site | Zabrze | 41-800 | Poland |
| Pfizer Investigational Site | Moscow | 115478 | Russia |
| Pfizer Investigational Site | Moscow | 125412 | Russia |
| Pfizer Investigational Site | Lund | 221 85 | Sweden |
| Pfizer Investigational Site | Kaohsiung City | 81346 | Taiwan |
| Pfizer Investigational Site | Taipei | 100 | Taiwan |
| Pfizer Investigational Site | Taipei | 11217 | Taiwan |
| 24637559 | Derived | Barst RJ, Beghetti M, Pulido T, Layton G, Konourina I, Zhang M, Ivy DD; STARTS-2 Investigators. STARTS-2: long-term survival with oral sildenafil monotherapy in treatment-naive pediatric pulmonary arterial hypertension. Circulation. 2014 May 13;129(19):1914-23. doi: 10.1161/CIRCULATIONAHA.113.005698. Epub 2014 Mar 17. |
Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
| FG002 | Sildenafil High/ High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156 |
| FG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| FG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| FG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| FG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil Low/Low Dose | Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156 |
| BG001 | Sildenafil Medium/ Medium Dose | Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156 |
| BG002 | Sildenafil High/ High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156 |
| BG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| BG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| BG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| BG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Number of Participants Reporting at Least One Adverse Event | Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the adverse events according to the A1481156 treatment groups are provided in the reported adverse event section. | The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913). | Posted | Number | Participants | Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation) |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Treatment-related Adverse Events | Safety was measured according to standard adverse event collection as described in the adverse event section of the results. | The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913). | Posted | Number | Participants | Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting at Least One Serious Adverse Event | Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the serious adverse events according to the A1481156 treatment groups are provided in the reported adverse event section. | The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913). | Posted | Number | Participants | Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Treatment-related Serious Adverse Events | All serious adverse events regardless of treatment group or suspected relationship to study drug were reported. Investigators were to provide independent determination of possible causality of any serious adverse event. | The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913). | Posted | Number | Participants | Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Deaths Reported in the Study Prior to the Data Monitoring Committee (DMC) Recommendation of Dose Down Titration | Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later. | The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913). | Posted | Number | Participants | Pre-DMC Recommendation dose down titration (04 August 2011) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Deaths Reported During This Study | Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later. | The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913). | Posted | Number | Participants | Last follow-up visit or 30 days after the last administration of study drug |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Discontinuation Due to Intolerability | Participant who experienced drug-related intolerance, the participant's dose was reduced by 50%. If, after a dose reduction, the participant continued to appear intolerant, they were discontinued from study treatment. | Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). | Posted | Number | Participants | Throughout the treatment duration (median treatment duration 1689 to 1744 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Downtitration in Dose Due to Intolerability. | Based on review of the survival data, DMC concluded that the high dose of sildenafil was associated with a harmful effect on survival when compared to the low dose. The DMC also expressed concern as to the potential dose-response relationship between increasing dose and mortality. Therefore, on 04 August 2011, the DMC recommended discontinuation of the 40 mg and 80 mg three times a day (TID) doses, as well as the 20 mg TID dose in children with body weight ≤20 kg. The protocol was amended per DMC recommendations. | Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). | Posted | Number | Participants | Pre-DMC recomendation (04 August 2011) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Deterioration Post Baseline in Visual Acuity Safety Tests | Visual Acuity is measured either using the reduced Snellen test or via Teller cards, and was assessed in the left and right eyes separately. There were 9 lines on the reduced Snellen chart which were coded as 6/60, 6/36, 6/24, 6/18, 6/12, 6/9, 6/6, 6/5, 6/4 (where 6/60 was the easiest to read and 6/4 was the most difficult to read). If a participant experienced a visual adverse event the investigator was asked to perform additional ocular assessments either at the visit when the participant reported the visual adverse event or at an unplanned visit. | Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). | Posted | Number | Participants | Week 36 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Deterioration Post Baseline in Color Vision Monitoring Safety Tests. | Colour vision was measured where appropriate via the Farnsworth-Munsell D-15 Hue test. This test was performed in both eyes simultaneously or just in a single specific eye. If using a single eye the same eye was used throughout the study. In case of young participants an age-and-ability-appropriate evaluation such as the Ishihara Test for Unlettered Persons were conducted. | Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). | Posted | Number | Participants | Week 36 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Pediatric Cognitive Development Status at Week 16. | Participant's cognitive development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited. | Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table. | Posted | Number | Participants | Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Pediatric Cognitive Development Status at Week 52. | Participant's cognitive development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited. | Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table. | Posted | Number | Participants | Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Pediatric Motor Development Status at Week 16. | Participant's motor development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited. | Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table. | Posted | Number | Participants | Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Pediatric Motor Development Status at Week 52 | Participant's motor development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited. | Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table. | Posted | Number | Participants | Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Volume of Oxygen (VO2) Consumed at Year 1 Using a Bicycle Ergometry Cardiopulmonary Exercise Test (CPX) | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the peak volume of VO2 consumed. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant | An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis. | Posted | Mean | Standard Deviation | mL/kg/min | 1 year |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Percent Predicted Peak VO2 at Year 1. | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the percent predicted peak VO2 at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis. | Posted | Mean | Standard Deviation | Percent | Baseline, Year 1 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Time to Maximum VO2 at Year 1 | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the time to maximum VO2. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis. | Posted | Mean | Standard Deviation | Percent | Baseline, Year 1 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Respiratory Exchange Ratio at Year 1 | This is the ratio of carbon dioxide (CO2) produced to O2 consumed [VCO2/VO2]. Exercise Tolerance Test was performed on developmentally able participants to determine the respiratory exchange ratio on week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). | An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis. | Posted | Mean | Standard Deviation | Percent | Baseline, Year 1 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Start of Sildenafil in Total Ventilation (VE) to Year 1 | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the total ventilation. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis. | Posted | Mean | Standard Deviation | Percent | Year 1 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in End Tidal Oxygen (O2) at Year 1. | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal O2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis. | Posted | Mean | Standard Deviation | Percent | Baseline, Year 1 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in End Tidal Carbon Dioxide (CO2) at Year 1. | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal CO2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis. | Posted | Mean | Standard Deviation | Percent | Baseline, Year 1 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Anaerobic Threshold at Year 1. | Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the anaerobic threshold at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant. | An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis. | Posted | Mean | Standard Deviation | Percent | Baseline, Year 1 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of Shift in Changes From Start of Sildenafil in World Health Organization Pulmonary Hypertension (WHO PH) Functional Class by A1481156 Treatment Group at Year 1. | The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarized at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated. | An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. | Posted | Number | Participants | Baseline, Year 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 2. | The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated. | An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. | Posted | Number | Participants | Baseline, Year 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 3. | The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 (NCT00159913) baseline at Years 1, 2, 3 and 4 were evaluated. | An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. | Posted | Number | Participants | Baseline, Year 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 4. | The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated. | An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. | Posted | Number | Participants | Baseline, Year 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Additions From Baseline in Background Therapy up to the End of Study | This was defined as an addition or discontinuation in the class(es) of drugs used as background medication (e.g., anticoagulants, oxygen, diuretics, calcium channel blockers, and digoxin) compared to baseline of Study A1481131 (NCT00159913). | An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. | Posted | Number | Participants | Up to the end of study |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Psychosocial Scale at Year 1. | CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status. | ITT population included all randomized participants who took at least 1 dose of study drug in base study; certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4, 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Participants >= 5 years at baseline with questionnaire translated were included. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Year 1 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Physical Scale at Year 1. | CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status. | ITT population included all randomized participants who took at least 1 dose of study drug in base study; certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4, 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Participants >= 5 years at baseline with questionnaire translated were included. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Year 1 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participant (Parent) Global Assessment at Year 1 | The participant (parent) global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments. | An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. | Posted | Number | Participants | Year 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Physician Global Assessment at Year 1 | The physician global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants with markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments. | An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. | Posted | Number | Participants | Year 1 |
|
Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)
The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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 | Sildenafil Low Dose | Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156 | 14 | 55 | 51 | 55 | ||
| EG001 | Sildenafil Medium Dose | Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156 | 37 | 74 | 70 | 74 | ||
| EG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 | 48 | 100 | 87 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tachycardia paroxysmal | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cystic fibrosis | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Eisenmenger's syndrome | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hip dysplasia | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Keratoconus | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Exposure via father | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Catheterisation cardiac | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pulmonary arterial pressure increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Anorexia nervosa | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Enuresis | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cardiac operation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Retinal vascular disorder | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood pressure diastolic decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
| 5-12 |
|
| 13-17 |
|
| >=18 |
|
| Male |
|
Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| Placebo/ Low Dose |
Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|
Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
|
|
Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
|
|
| OG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| OG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| OG003 |
| Placebo/ Low Dose |
Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| OG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| OG003 |
| Placebo/ Low Dose |
Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
|
|
| OG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| OG003 |
| Placebo/ Low Dose |
Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
|
|
| Sildenafil Medium Dose |
Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156 |
| OG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|
|
| OG002 | Sildenafil High/ High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156 |
| OG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| OG002 | Sildenafil High/ High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156 |
| OG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
| OG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156 |
| OG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|
Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156 |
| OG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|
Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156 |
| OG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|
| OG002 | Sildenafil High/ High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156 |
| OG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| Sildenafil Medium Dose |
Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156 |
| OG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|
Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156 |
| OG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|
Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156 |
| OG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|
Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156 |
| OG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|
| OG003 |
| Placebo/ Low Dose |
Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| OG002 |
| Sildenafil High/ High Dose |
Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156 |
| OG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| OG002 |
| Sildenafil High/ High Dose |
Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156 |
| OG003 | Placebo/ Low Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156 |
| OG004 | Placebo/ Medium Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156 |
| OG005 | Placebo/ High Dose | Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156 |
| OG006 | Placebo Non-randomized | This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156 |
|
|
| OG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|
| OG002 | Sildenafil High Dose | Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156 |
|
|