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A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

Primary Purpose

Pulmonary Arterial Hypertension

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Sildenafil citrate

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring children

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must complete the 16 Week double-blind efficacy study A1481131. Exclusion Criteria: Any patient who did not complete Study A1481131.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Sildenafil high dose

Sildenafil Low dose

Sildenafil medium dose

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Number of Deaths Reported During This Study

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

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

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Physical Scale at 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.

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.

Full Information

NCT ID

NCT00159874

First Posted

September 8, 2005

Last Updated

January 28, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00159874

Brief Title

A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

Official Title

A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension

Keywords

children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

234 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sildenafil high dose

Arm Type

Experimental

Arm Description

Arm Title

Sildenafil Low dose

Arm Type

Experimental

Arm Title

Sildenafil medium dose

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sildenafil citrate

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Sildenafil citrate

Intervention Description

Oral,10 mg 3 times a day (tid), only subjects with body weight >20 kg

Intervention Type

Drug

Intervention Name(s)

Sildenafil citrate

Intervention Description

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)

Primary Outcome Measure Information:

Title

Number of Participants Reporting at Least One Adverse Event

Description

Time Frame

Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)

Title

Number of Participants Reporting Treatment-related Adverse Events

Description

Safety was measured according to standard adverse event collection as described in the adverse event section of the results.

Time Frame

Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)

Title

Number of Participants Reporting at Least One Serious Adverse Event

Description

Time Frame

Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)

Title

Number of Participants Reporting Treatment-related Serious Adverse Events

Description

Time Frame

Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)

Title

Number of Deaths Reported in the Study Prior to the Data Monitoring Committee (DMC) Recommendation of Dose Down Titration

Description

Time Frame

Pre-DMC Recommendation dose down titration (04 August 2011)

Title

Number of Deaths Reported During This Study

Description

Time Frame

Last follow-up visit or 30 days after the last administration of study drug

Title

Discontinuation Due to Intolerability

Description

Time Frame

Throughout the treatment duration (median treatment duration 1689 to 1744 days)

Title

Downtitration in Dose Due to Intolerability.

Description

Time Frame

Pre-DMC recomendation (04 August 2011)

Title

Number of Participants With Deterioration Post Baseline in Visual Acuity Safety Tests

Description

Time Frame

Week 36

Title

Number of Participants With Deterioration Post Baseline in Color Vision Monitoring Safety Tests.

Description

Time Frame

Week 36

Title

Pediatric Cognitive Development Status at Week 16.

Description

Time Frame

Week 16

Title

Pediatric Cognitive Development Status at Week 52.

Description

Time Frame

Week 52

Title

Pediatric Motor Development Status at Week 16.

Description

Time Frame

Week 16

Title

Pediatric Motor Development Status at Week 52

Description

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Peak Volume of Oxygen (VO2) Consumed at Year 1 Using a Bicycle Ergometry Cardiopulmonary Exercise Test (CPX)

Description

Time Frame

1 year

Title

Percentage Change From Baseline in Percent Predicted Peak VO2 at Year 1.

Description

Time Frame

Baseline, Year 1

Title

Percent Change From Baseline in Time to Maximum VO2 at Year 1

Description

Time Frame

Baseline, Year 1

Title

Percent Change From Baseline in Respiratory Exchange Ratio at Year 1

Description

Time Frame

Baseline, Year 1

Title

Percent Change From Start of Sildenafil in Total Ventilation (VE) to Year 1

Description

Time Frame

Year 1

Title

Percentage Change From Baseline in End Tidal Oxygen (O2) at Year 1.

Description

Time Frame

Baseline, Year 1

Title

Percentage Change From Baseline in End Tidal Carbon Dioxide (CO2) at Year 1.

Description

Time Frame

Baseline, Year 1

Title

Percentage Change From Baseline in Anaerobic Threshold at Year 1.

Description

Time Frame

Baseline, Year 1

Title

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.

Description

Time Frame

Baseline, Year 1

Title

Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 2.

Description

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.

Time Frame

Baseline, Year 2

Title

Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 3.

Description

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.

Time Frame

Baseline, Year 3

Title

Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 4.

Description

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.

Time Frame

Baseline, Year 4

Title

Additions From Baseline in Background Therapy up to the End of Study

Description

Time Frame

Up to the end of study

Title

Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Psychosocial Scale at Year 1.

Description

Time Frame

Baseline, Year 1

Title

Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Physical Scale at Year 1.

Description

Time Frame

Baseline, Year 1

Title

Participant (Parent) Global Assessment at Year 1

Description

Time Frame

Year 1

Title

Physician Global Assessment at Year 1

Description

Time Frame

Year 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must complete the 16 Week double-blind efficacy study A1481131. Exclusion Criteria: Any patient who did not complete Study A1481131.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

34304

Country

United States

Facility Name

Pfizer Investigational Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Pfizer Investigational Site

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Pfizer Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Pfizer Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Pfizer Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Facility Name

Pfizer Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Pfizer Investigational Site

City

Sao Paulo

State/Province

ZIP/Postal Code

04012-909

Country

Brazil

Facility Name

Pfizer Investigational Site

City

São Paulo

State/Province

ZIP/Postal Code

04023-062

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Puente Alto

State/Province

Santiago

Country

Chile

Facility Name

Pfizer Investigational Site

City

Medellin

State/Province

Antioquia

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Guatemala

Country

Guatemala

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

1096

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500 001

Country

India

Facility Name

Pfizer Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500 073

Country

India

Facility Name

Pfizer Investigational Site

City

Kochi

State/Province

Kerala

ZIP/Postal Code

682 041

Country

India

Facility Name

Pfizer Investigational Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Pfizer Investigational Site

City

Tokyo

Country

Japan

Facility Name

Pfizer Investigational Site

City

Penang

ZIP/Postal Code

10050

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Penang

ZIP/Postal Code

10900

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Penang

ZIP/Postal Code

11600

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Mexico

State/Province

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

30-663

Country

Poland

Facility Name

Pfizer Investigational Site

City

Ruda Slaska

ZIP/Postal Code

41-703

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Pfizer Investigational Site

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

125412

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Kaohsiung

ZIP/Postal Code

81346

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

31908813

Citation

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.

Results Reference

derived

PubMed Identifier

31538282

Citation

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.

Results Reference

derived

PubMed Identifier

24637559

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481156&StudyName=A%20Long%20Term%20Extension%20Study%20Evaluating%20Safety%20Of%20Sildenafil%20Citrate%20When%20Used%20To%20Treat%20Pulmonary%20Arterial%20Hypertension%20%28PAH%29%20In%20Chil

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A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

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A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

Pulmonary Arterial Hypertension

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