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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02060487




Registration number
NCT02060487
Ethics application status
Date submitted
29/01/2014
Date registered
12/02/2014

Titles & IDs
Public title
Effects of Oral Sildenafil on Mortality in Adults With PAH
Scientific title
A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
Secondary ID [1] 0 0
2013-004362-34
Secondary ID [2] 0 0
A1481324
Universal Trial Number (UTN)
Trial acronym
AFFILIATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - sildenafil citrate
Treatment: Drugs - sildenafil citrate
Treatment: Drugs - sildenafil citrate

Experimental: Low dose -

Experimental: Medium dose -

Experimental: High dose -


Treatment: Drugs: sildenafil citrate
sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study

Treatment: Drugs: sildenafil citrate
sildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study

Treatment: Drugs: sildenafil citrate
sildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)
Secondary outcome [1] 0 0
Number of Participants With Clinical Worsening Events
Timepoint [1] 0 0
Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days)
Secondary outcome [2] 0 0
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6
Timepoint [2] 0 0
Baseline, Month 6
Secondary outcome [3] 0 0
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12
Timepoint [3] 0 0
Baseline, Month 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/02/2021
Sample size
Target
Accrual to date
Final
385
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [4] 0 0
Australian Respiratory and Sleep Medicine Institute - Bedford Park
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Belgium
State/province [6] 0 0
Yvoir
Country [7] 0 0
Bosnia and Herzegovina
State/province [7] 0 0
B&h/republic OF Srpska
Country [8] 0 0
Bosnia and Herzegovina
State/province [8] 0 0
Bosnia AND Herzegovina/canton Sarajevo
Country [9] 0 0
Bosnia and Herzegovina
State/province [9] 0 0
Canton Tuzla
Country [10] 0 0
Bosnia and Herzegovina
State/province [10] 0 0
Herzegovina-neretva Canton
Country [11] 0 0
Croatia
State/province [11] 0 0
Zagreb
Country [12] 0 0
Czechia
State/province [12] 0 0
Czech Republic
Country [13] 0 0
Czechia
State/province [13] 0 0
Olomouc
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha 4
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Dresden
Country [17] 0 0
Germany
State/province [17] 0 0
Greifswald
Country [18] 0 0
Germany
State/province [18] 0 0
Hamburg
Country [19] 0 0
Germany
State/province [19] 0 0
Heidelberg
Country [20] 0 0
Germany
State/province [20] 0 0
Luebeck
Country [21] 0 0
Greece
State/province [21] 0 0
Attiki
Country [22] 0 0
Greece
State/province [22] 0 0
Evros
Country [23] 0 0
Greece
State/province [23] 0 0
Patras
Country [24] 0 0
Greece
State/province [24] 0 0
Thessaloniki
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Hong Kong
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Shatin, New Territories
Country [27] 0 0
Israel
State/province [27] 0 0
Tel-Hashomer
Country [28] 0 0
Latvia
State/province [28] 0 0
Riga
Country [29] 0 0
Malaysia
State/province [29] 0 0
Johor
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kedah
Country [31] 0 0
Malaysia
State/province [31] 0 0
Selangor
Country [32] 0 0
Malaysia
State/province [32] 0 0
Kuala Lumpur
Country [33] 0 0
Mexico
State/province [33] 0 0
Nuevo LEÓN
Country [34] 0 0
Mexico
State/province [34] 0 0
Yucatan
Country [35] 0 0
Mexico
State/province [35] 0 0
Queretaro
Country [36] 0 0
Poland
State/province [36] 0 0
Lublin
Country [37] 0 0
Romania
State/province [37] 0 0
Cluj-Napoca
Country [38] 0 0
Romania
State/province [38] 0 0
Targu-Mures
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Kemerovo
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Moscow
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Novosibirsk
Country [42] 0 0
Russian Federation
State/province [42] 0 0
St. Petersburg
Country [43] 0 0
Serbia
State/province [43] 0 0
Vojvodina
Country [44] 0 0
Serbia
State/province [44] 0 0
Belgrade
Country [45] 0 0
Serbia
State/province [45] 0 0
Kragujevac
Country [46] 0 0
Singapore
State/province [46] 0 0
Singapore
Country [47] 0 0
South Africa
State/province [47] 0 0
Gauteng
Country [48] 0 0
Spain
State/province [48] 0 0
Cataluña
Country [49] 0 0
Thailand
State/province [49] 0 0
Bangkok
Country [50] 0 0
Thailand
State/province [50] 0 0
Chiang MAI
Country [51] 0 0
Thailand
State/province [51] 0 0
Khon Kaen
Country [52] 0 0
Turkey
State/province [52] 0 0
Bakirkoy
Country [53] 0 0
Turkey
State/province [53] 0 0
Fatih
Country [54] 0 0
Turkey
State/province [54] 0 0
Inciralti
Country [55] 0 0
Turkey
State/province [55] 0 0
Pendik
Country [56] 0 0
Ukraine
State/province [56] 0 0
Kharkiv,
Country [57] 0 0
Ukraine
State/province [57] 0 0
Kyiv
Country [58] 0 0
Ukraine
State/province [58] 0 0
M. Dnipro
Country [59] 0 0
Ukraine
State/province [59] 0 0
Uzhhorod,

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02060487