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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02060487




Registration number
NCT02060487
Ethics application status
Date submitted
29/01/2014
Date registered
12/02/2014
Date last updated
13/05/2022

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
Terminated
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02060487
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02060487