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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00644605




Registration number
NCT00644605
Ethics application status
Date submitted
20/03/2008
Date registered
27/03/2008
Date last updated
1/02/2021

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension
Scientific title
A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over
Secondary ID [1] 0 0
A1481140
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary 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
Treatment: Drugs - sildenafil
Treatment: Drugs - placebo
Treatment: Drugs - sildenafil

Active comparator: Arm 1 -

Active comparator: Arm 2 -

Active comparator: Arm 3 -

Placebo comparator: Arm 4 -


Treatment: Drugs: sildenafil
sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

Treatment: Drugs: sildenafil
sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID

Treatment: Drugs: placebo
placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

Treatment: Drugs: sildenafil
sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test).
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change from baseline in mean pulmonary arterial pressure
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Time from randomisation to the first occurrence of clinical worsening (death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy)
Timepoint [2] 0 0
Week 0 to 12
Secondary outcome [3] 0 0
Change from baseline in the BORG dyspnoea score
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Change from baseline in the 8 dimensions of SF-36 (Physical functioning, Role functioning, Bodily pain, General health, Vitality, Social functioning, Mental health and Reported health transition)
Timepoint [5] 0 0
Week 4 and Week 12
Secondary outcome [6] 0 0
Change from baseline at Weeks 4 and 12 in the 5 dimensions of ED5Q (Mobility, Self care, Usual Activities, Pain/Discomfort and Anxiety/Depression)
Timepoint [6] 0 0
Week 4 and Week 12
Secondary outcome [7] 0 0
Patient overall preference assessment
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Change in Chronic Use of Background Therapy for Pulmonary Arterial Hypertension
Timepoint [8] 0 0
throughout the study
Secondary outcome [9] 0 0
Change from baseline in hemodynamic parameters
Timepoint [9] 0 0
Week 12

Eligibility
Key inclusion criteria
Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.

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 analysing the results/data
Intervention assignment
Parallel
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
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2003
Sample size
Target
275
Accrual to date
Final
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
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Brazil
State/province [17] 0 0
SP
Country [18] 0 0
Czechia
State/province [18] 0 0
Prague 4
Country [19] 0 0
Denmark
State/province [19] 0 0
Kobenhavn
Country [20] 0 0
France
State/province [20] 0 0
Clamart
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Giessen
Country [23] 0 0
Germany
State/province [23] 0 0
Hannover
Country [24] 0 0
Germany
State/province [24] 0 0
Leipzig
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Shatin N T
Country [26] 0 0
Hungary
State/province [26] 0 0
Pest
Country [27] 0 0
Hungary
State/province [27] 0 0
Zala
Country [28] 0 0
Israel
State/province [28] 0 0
Petach Tikva
Country [29] 0 0
Israel
State/province [29] 0 0
Tel Hashomer
Country [30] 0 0
Italy
State/province [30] 0 0
Bologna
Country [31] 0 0
Italy
State/province [31] 0 0
Pisa
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Suwon
Country [33] 0 0
Malaysia
State/province [33] 0 0
Kuala Lumpur
Country [34] 0 0
Mexico
State/province [34] 0 0
Tlalpan
Country [35] 0 0
Netherlands
State/province [35] 0 0
Amsterdam
Country [36] 0 0
Norway
State/province [36] 0 0
Oslo
Country [37] 0 0
Poland
State/province [37] 0 0
Katowice
Country [38] 0 0
Poland
State/province [38] 0 0
Warszawa
Country [39] 0 0
Poland
State/province [39] 0 0
Zabrze
Country [40] 0 0
Singapore
State/province [40] 0 0
Singapore
Country [41] 0 0
South Africa
State/province [41] 0 0
Cape Town
Country [42] 0 0
South Africa
State/province [42] 0 0
Johannesburg
Country [43] 0 0
South Africa
State/province [43] 0 0
Parow
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Sweden
State/province [46] 0 0
Goteborg
Country [47] 0 0
Sweden
State/province [47] 0 0
Molndal
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Cambridgeshire
Country [49] 0 0
United Kingdom
State/province [49] 0 0
South Yorkshire
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Glasgow
Country [51] 0 0
United Kingdom
State/province [51] 0 0
HIGH Heaton, Newcastle-upon-tyne

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
To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day \[TID\]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.
Trial website
https://clinicaltrials.gov/study/NCT00644605
Trial related presentations / publications
Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.
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/study/NCT00644605