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Effects of Oral Sildenafil on Mortality in Adults With PAH (AFFILIATE)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
sildenafil citrate
sildenafil citrate
sildenafil citrate
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 Arterial Hypertension focused on measuring pulmonary arterial hypertension, pulmonary hypertension, PAH, sildenafil, revatio

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects ≥ 18 <75 years of age with any of the following conditions:

  • Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
  • PAH secondary to connective tissue disease
  • PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window
  • PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
  • Functional Class II-IV; Baseline 6MWD ≥ 50 m.

Exclusion Criteria:

  • Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
  • History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
  • History of pulmonary embolism; History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function
  • No prior long term treatment with PDE-5 inhibitors
  • Treatment with bosentan OR riociguat within 3 months of randomization
  • Current treatment with nitrates or nitric oxide

Sites / Locations

  • Emory University Investigational Drug Services
  • The Emory Clinic
  • Frederik Meijer Heart & Vascular Institute Cardiovascular Research
  • Spectrum Health Butterworth Hospital IDS Pharmacy
  • Spectrum Health Heart & Lung Specialized Care Clinic
  • Spectrum Health Hospitals
  • Spectrum Health Medical Group - Pulmonary Division
  • Spectrum Health
  • Robert V. Sibilia MD, Inc.
  • UT Southwestern Medical School
  • Aurora St. Luke's Medical Center
  • St. Vincent's Hospital
  • Westmead Hospital
  • Royal Brisbane & Women's Hospital
  • Australian Respiratory and Sleep Medicine Institute
  • University Hospital of Mont-Godinne
  • University Clinical Center of the Republic of Srpska
  • Clinical Center University Sarajevo
  • Health Institution Special Hospital "Medical Institute Bayer"
  • University Clinical Hospital Mostar
  • University Hospital Center Zagreb
  • University Hospital Dubrava
  • Vseobecna fakultni nemocnice v Praze
  • Fakultni nemocnice Olomouc
  • Institut Klinicke a Experimentalni Mediciny
  • DRK Kliniken Berlin, Westend
  • Universitaetsklinikum der TU Dresden
  • Universitatsklinikum TU Dresden
  • Universitaetsmedizin Greifswald
  • Universitaetsklinikum Hamburg-Eppendorf
  • Thoraxklinik am Universitaetsklinikum Heidelberg
  • Universitaetsklinikum Schleswig-Holstein
  • University General Hospital of Athens "Attikon"
  • University General Hospital of Alexandroupolis
  • University General Hospital of Patras
  • University General Hospital of Thessaloniki AHEPA
  • Queen Mary Hospital
  • Prince of Wales Hospital
  • The Chaim Sheba Medical Center
  • Pauls Stradins Clinical University Hospital
  • Hospital Sultanah Aminah
  • Hospital Sultanah Bahiyah
  • Hospital Serdang
  • University Malaya Medical Centre
  • Centro De Prevencion Y Rehabilitacion De Enfermedades Pulmonares Crónicas
  • Centro de Desarrollo Biomedico
  • Centro de Estudios Clinicos de Queretaro S.C.
  • Samodzielny Publiczny Szpital Kliniczny nr 4
  • Institutul Inimii ,,Niculae Stancioiu" Cluj Napoca
  • Institutul de Urgenta pentru Boli Cardiovasculare si Transplant Targu-Mures
  • FSBI "Research Institute of complex problems of cardiovascular diseases"
  • FSBI Scientific Research Institute of Pulmonology of FMBA
  • FSBI "E.Meshalkin National medical research center"
  • FSBI "V.A. Almazov National Medical Research Center"
  • Institute for Cardiovascular disease of Vojvodina
  • Institute for Pulmonary Diseases of Vojvodina
  • Clinical Center of Serbia
  • University Medical Center Zvezdara
  • Clinical Center Kragujevac
  • National University Heart Centre, National University Hospital Singapore (NUHS)
  • Khoo Teck Puat Hospital
  • Center of Chest Diseases
  • Dr PG Williams Practice
  • Hospital Universitario Vall d´Hebrón
  • Faculty of Medicine, Chulalongkorn University
  • King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
  • Maharaj Nakorn Chiang Mai Hospital
  • Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
  • Division of Cardiology, Department of Medicine, Faculty of Medicine, Khon Kaen University
  • Queen Sirikit Heart Center of the Northeast, Khon Kaen University
  • Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
  • Bakirkoy Dr. Sadi Konuk Training and Research Hospital
  • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul University Haseki Cardiology Institute
  • Dokuz Eylul Üniversitesi Tıp Fakültesi Kardiyoloji Bilim Dalı
  • Marmara University Pendik Training and Research Hospital
  • Komunalne nekomertsiine pidpryiemstvo
  • Komunalne nekomertsiine pidpryiemstvo Oleksandrivska klinichna likarnia m. Kyieva
  • Komunalne nekomertsiine pidpryiemstvo
  • Derzhavna ustanova Natsionalnyi naukovyi tsentr
  • Komunalne pidpryiemstvo "Dnipropetrovskyi oblasnyi klinichnyi tsentr kardiolohii ta kardiokhirurhii"
  • Komunalne nekomertsiine pidpryiemstvo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low dose

Medium dose

High dose

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival
In this outcome measure number of deaths during the study were reported.

Secondary Outcome Measures

Number of Participants With Clinical Worsening Events
Clinical worsening was defined as all-cause mortality, non-elective hospital stay for worsening pulmonary arterial hypertension (PAH) (including but not limited to right heart failure [RHF], initiation of intravenous (IV) prostanoids, lung transplantation, or septostomy) or disease progression. Disease progression was defined as a reduction from baseline in the 6-Minute Walk Distance (6MWD) test by 15% and worsening functional class from baseline, both confirmed by second test within 2 weeks of study treatment.
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.

Full Information

First Posted
January 29, 2014
Last Updated
May 11, 2022
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02060487
Brief Title
Effects of Oral Sildenafil on Mortality in Adults With PAH
Acronym
AFFILIATE
Official Title
A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met.
Study Start Date
September 22, 2014 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
February 26, 2021 (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

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
pulmonary arterial hypertension, pulmonary hypertension, PAH, sildenafil, revatio

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Title
Medium dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate
Other Intervention Name(s)
Revatio
Intervention Description
sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate
Other Intervention Name(s)
Revatio
Intervention Description
sildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate
Other Intervention Name(s)
Revatio
Intervention Description
sildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study
Primary Outcome Measure Information:
Title
Overall Survival
Description
In this outcome measure number of deaths during the study were reported.
Time Frame
Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)
Secondary Outcome Measure Information:
Title
Number of Participants With Clinical Worsening Events
Description
Clinical worsening was defined as all-cause mortality, non-elective hospital stay for worsening pulmonary arterial hypertension (PAH) (including but not limited to right heart failure [RHF], initiation of intravenous (IV) prostanoids, lung transplantation, or septostomy) or disease progression. Disease progression was defined as a reduction from baseline in the 6-Minute Walk Distance (6MWD) test by 15% and worsening functional class from baseline, both confirmed by second test within 2 weeks of study treatment.
Time Frame
Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days)
Title
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6
Description
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.
Time Frame
Baseline, Month 6
Title
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12
Description
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.
Time Frame
Baseline, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects ≥ 18 <75 years of age with any of the following conditions: Idiopathic Primary Pulmonary Arterial Hypertension (IPAH) PAH secondary to connective tissue disease PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization Functional Class II-IV; Baseline 6MWD ≥ 50 m. Exclusion Criteria: Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation History of pulmonary embolism; History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function No prior long term treatment with PDE-5 inhibitors Treatment with bosentan OR riociguat within 3 months of randomization Current treatment with nitrates or nitric oxide
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
Emory University Investigational Drug Services
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Frederik Meijer Heart & Vascular Institute Cardiovascular Research
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health Butterworth Hospital IDS Pharmacy
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health Heart & Lung Specialized Care Clinic
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health Medical Group - Pulmonary Division
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Robert V. Sibilia MD, Inc.
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
UT Southwestern Medical School
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8550
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Australian Respiratory and Sleep Medicine Institute
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
University Hospital of Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
University Clinical Center of the Republic of Srpska
City
Banja Luka
State/Province
B&h/republic OF Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University Sarajevo
City
Sarajevo
State/Province
Bosnia AND Herzegovina/canton Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Health Institution Special Hospital "Medical Institute Bayer"
City
Tuzla
State/Province
Canton Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Hospital Mostar
City
Mostar
State/Province
Herzegovina-neretva Canton
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
University Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
University Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
State/Province
Czech Republic
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Institut Klinicke a Experimentalni Mediciny
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
DRK Kliniken Berlin, Westend
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Universitaetsklinikum der TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Thoraxklinik am Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
University General Hospital of Athens "Attikon"
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Facility Name
University General Hospital of Alexandroupolis
City
Alexandroupolis
State/Province
Evros
ZIP/Postal Code
68100
Country
Greece
Facility Name
University General Hospital of Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
University General Hospital of Thessaloniki AHEPA
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
Country
Hong Kong
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Hospital Sultanah Aminah
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
80100
Country
Malaysia
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05460
Country
Malaysia
Facility Name
Hospital Serdang
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Centro De Prevencion Y Rehabilitacion De Enfermedades Pulmonares Crónicas
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro de Desarrollo Biomedico
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Centro de Estudios Clinicos de Queretaro S.C.
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Institutul Inimii ,,Niculae Stancioiu" Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400001
Country
Romania
Facility Name
Institutul de Urgenta pentru Boli Cardiovasculare si Transplant Targu-Mures
City
Targu-Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
FSBI "Research Institute of complex problems of cardiovascular diseases"
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
FSBI Scientific Research Institute of Pulmonology of FMBA
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
FSBI "E.Meshalkin National medical research center"
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
FSBI "V.A. Almazov National Medical Research Center"
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Institute for Cardiovascular disease of Vojvodina
City
Sremska Kamenica
State/Province
Vojvodina
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Institute for Pulmonary Diseases of Vojvodina
City
Sremska Kamenica
State/Province
Vojvodina
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Medical Center Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
Facility Name
National University Heart Centre, National University Hospital Singapore (NUHS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Khoo Teck Puat Hospital
City
Singapore
ZIP/Postal Code
768828
Country
Singapore
Facility Name
Center of Chest Diseases
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Dr PG Williams Practice
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Hospital Universitario Vall d´Hebrón
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Pathumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
City
Pathumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Muang
State/Province
Chiang MAI
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
City
Sripoom Sub-district, Muang
State/Province
Chiang MAI
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Division of Cardiology, Department of Medicine, Faculty of Medicine, Khon Kaen University
City
Muang District
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Queen Sirikit Heart Center of the Northeast, Khon Kaen University
City
Muang District
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
City
Muang District
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Istanbul University Haseki Cardiology Institute
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Dokuz Eylul Üniversitesi Tıp Fakültesi Kardiyoloji Bilim Dalı
City
Izmir
State/Province
Inciralti
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
State/Province
Pendik
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Komunalne nekomertsiine pidpryiemstvo
City
Kharkiv,
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo Oleksandrivska klinichna likarnia m. Kyieva
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Derzhavna ustanova Natsionalnyi naukovyi tsentr
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Komunalne pidpryiemstvo "Dnipropetrovskyi oblasnyi klinichnyi tsentr kardiolohii ta kardiokhirurhii"
City
M. Dnipro
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo
City
Uzhhorod,
ZIP/Postal Code
88000
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481324&StudyName=Effects%20of%20Oral%20Sildenafil%20on%20Mortality%20in%20Adults%20with%20PAH
Description
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Learn more about this trial

Effects of Oral Sildenafil on Mortality in Adults With PAH

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