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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/NCT00159887




Registration number
NCT00159887
Ethics application status
Date submitted
8/09/2005
Date registered
12/09/2005
Date last updated
1/02/2021

Titles & IDs
Public title
Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension
Scientific title
A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.
Secondary ID [1] 0 0
A1481142
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

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

Treatment: Drugs: Sildenafil citrate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
Primary outcome [2] 0 0
Standard safety data
Timepoint [2] 0 0
Primary outcome [3] 0 0
Efficacy
Timepoint [3] 0 0
Primary outcome [4] 0 0
6-Minute Walk Test
Timepoint [4] 0 0
Primary outcome [5] 0 0
BORG Dyspnoea Score
Timepoint [5] 0 0
Primary outcome [6] 0 0
WHO Functional Class
Timepoint [6] 0 0
Primary outcome [7] 0 0
Quality of Life SF-36 and EQ-5D
Timepoint [7] 0 0

Eligibility
Key inclusion criteria
- Patients with PAH who had completed the 12 week pivotal study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any other patients with PAH that had not been included into the pivotal study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
260
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Brazil
State/province [16] 0 0
SP
Country [17] 0 0
Czechia
State/province [17] 0 0
Prague 4
Country [18] 0 0
Denmark
State/province [18] 0 0
Kobenhavn
Country [19] 0 0
France
State/province [19] 0 0
Clamart Cedex
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Germany
State/province [20] 0 0
Giessen
Country [21] 0 0
Germany
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Hannover
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Germany
State/province [22] 0 0
Leipzig
Country [23] 0 0
Hong Kong
State/province [23] 0 0
Shatin NT
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Hungary
State/province [25] 0 0
Zalaegerszeg
Country [26] 0 0
Israel
State/province [26] 0 0
Petach Tikva
Country [27] 0 0
Israel
State/province [27] 0 0
Tel Hashomer
Country [28] 0 0
Italy
State/province [28] 0 0
Bologna
Country [29] 0 0
Italy
State/province [29] 0 0
Pisa
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Suwon
Country [31] 0 0
Malaysia
State/province [31] 0 0
Kuala Lumpur
Country [32] 0 0
Malaysia
State/province [32] 0 0
Petaling Jaya
Country [33] 0 0
Mexico
State/province [33] 0 0
DF
Country [34] 0 0
Mexico
State/province [34] 0 0
Mexico DF
Country [35] 0 0
Netherlands
State/province [35] 0 0
Amsterdam
Country [36] 0 0
Poland
State/province [36] 0 0
Warszawa
Country [37] 0 0
Poland
State/province [37] 0 0
Zabrze
Country [38] 0 0
Singapore
State/province [38] 0 0
Singapore
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South Africa
State/province [39] 0 0
Western Cape
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South Africa
State/province [40] 0 0
Parktown West
Country [41] 0 0
South Africa
State/province [41] 0 0
Parktown
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Spain
State/province [42] 0 0
Barcelona
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Sweden
State/province [44] 0 0
Goteborg
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Cambridgeshire
Country [46] 0 0
United Kingdom
State/province [46] 0 0
South Yorkshire
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Tyne And Wear
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Cambridge
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Glasgow

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
Open label extension study to the pivotal efficacy study to assess the safety of sildenafil
citrate in patients with pulmonary arterial hypertension
Trial website
https://clinicaltrials.gov/ct2/show/NCT00159887
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/NCT00159887