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Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
sildenafil citrate (UK-92,480)
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects aged 16 and over, and classified as having pulmonary arterial hypertension
  • Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest
  • Subjects whose baseline 6-Minute Walk test distance is >100 m and <450 m

Exclusion Criteria:

  • Significant Hepatic and/or renal disorder
  • Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)
  • Subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sildenafil citrate (UK-92,480)

Arm Description

sildenafil citrate 20 mg TID

Outcomes

Primary Outcome Measures

Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.
Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.
Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline
Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Cardiac output at Week 12 minus cardiac output at baseline

Secondary Outcome Measures

Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I
Change:6-minute walk distance at Week 8 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.
Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline.
Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline.
Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline.
Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline.
Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3. Change:Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline.
Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline.
Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Right atrial pressure at Week 12 minus right atrial pressure at baseline.
Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Cardiac index at Week 12 minus cardiac index at baseline.
Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Heart rate at Week 12 minus heart rate at baseline.
Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline.
Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline.
Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline.
Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline.
Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline.
Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline.
Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I
Change:Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline.
Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I
The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).
Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I
Change:BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I
Change:Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline
Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
Change:6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.
Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).
Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
Change:BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II
Change:Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline
Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320
Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant
Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320
Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant.
The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320
The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule
The Average Plasma Concentration (Css,av) of Sildenafil at Steady State
The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours).
The Average Plasma Trough Concentration (Ctrough) of Sildenafil
The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants.
Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
The total number of participants with laboratory test abnormalities without regard to baseline abnormality.

Full Information

First Posted
March 28, 2007
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00454207
Brief Title
Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
Official Title
A Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (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
No

5. Study Description

Brief Summary
To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary Arterial Hypertension, PAH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sildenafil citrate (UK-92,480)
Arm Type
Experimental
Arm Description
sildenafil citrate 20 mg TID
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate (UK-92,480)
Intervention Description
sildenafil citrate (UK-92,480)
Primary Outcome Measure Information:
Title
Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.
Time Frame
Baseline, Week 12
Title
Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline
Time Frame
Baseline, Week 12
Title
Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Cardiac output at Week 12 minus cardiac output at baseline
Time Frame
Baseline, week 12
Secondary Outcome Measure Information:
Title
Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I
Description
Change:6-minute walk distance at Week 8 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.
Time Frame
Baseline, Week 8
Title
Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3. Change:Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Right atrial pressure at Week 12 minus right atrial pressure at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Cardiac index at Week 12 minus cardiac index at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Heart rate at Week 12 minus heart rate at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline.
Time Frame
baseline, Week 12
Title
Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline.
Time Frame
Baseline, Week 12
Title
Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline.
Time Frame
baseline, Week 12
Title
Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I
Description
Change:Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline.
Time Frame
Baseline, Week 12
Title
Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I
Description
The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).
Time Frame
Baseline, Week 12
Title
Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I
Description
Change:BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.
Time Frame
Baseline, Week 8, Week 12
Title
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I
Description
Change:Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
Description
Change:6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.
Time Frame
Baseline, Week 12
Title
Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
Description
The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).
Time Frame
Baseline, Week 12
Title
Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II
Description
Change:BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.
Time Frame
Baseline, Week 12
Title
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II
Description
Change:Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline
Time Frame
Baseline, Week 12
Title
Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320
Description
Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
Title
Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320
Description
Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
Title
The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320
Description
The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
Title
The Average Plasma Concentration (Css,av) of Sildenafil at Steady State
Description
The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
Title
The Average Plasma Trough Concentration (Ctrough) of Sildenafil
Description
The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing
Title
Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Description
The total number of participants with laboratory test abnormalities without regard to baseline abnormality.
Time Frame
Baseline up to 1.3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects aged 16 and over, and classified as having pulmonary arterial hypertension Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest Subjects whose baseline 6-Minute Walk test distance is >100 m and <450 m Exclusion Criteria: Significant Hepatic and/or renal disorder Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION) Subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole
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
Chiba-shi
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tsu-shi
State/Province
Mie
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okayama City
State/Province
Okayama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hamamatsu-shi
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481252&StudyName=Open%20Label%20Study%20of%20Sildenafil%20in%20Patients%20with%20Pulmonary%20Arterial%20Hypertension%20%20
Description
To obtain contact information for a study center near you, click here.

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Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

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