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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/NCT00323297
Registration number
NCT00323297
Ethics application status
Date submitted
5/05/2006
Date registered
9/05/2006
Date last updated
1/02/2021
Titles & IDs
Public title
Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
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Scientific title
A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)
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Secondary ID [1]
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2006-001464-23
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Secondary ID [2]
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A1481243
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bosentan
Other interventions - Placebo
Treatment: Drugs - Bosentan
Treatment: Drugs - Sildenafil Citrate
Placebo Comparator: placebo -
Experimental: Active -
Treatment: Drugs: Bosentan
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Other interventions: Placebo
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Treatment: Drugs: Bosentan
Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
Treatment: Drugs: Sildenafil Citrate
Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12
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Assessment method [1]
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6MWT is 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. Continuous pulse oximetry was conducted during the test for safety.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF
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Assessment method [1]
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WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class; deterioration = increase in functional class, no change = no change in functional class.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Clinical Worsening Events
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Assessment method [2]
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No survival analysis was carried out for the study due to very few events of clinical worsening. Hence, we present a summary of clinical worsening events instead.
Events of clinical worsening were categorized as (A). Death, (B). Heart/lung transplantation, (C). Hospitalization due to pulmonary arterial hypertension (PAH), and (D). Clinical deterioration of PAH requiring additional therapy.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Change From Baseline in Borg Dyspnea Score at Week 12
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Assessment method [3]
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Borg dyspnea scale is a 10-point scale where following scores stands for severity of dyspnea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]);
(very slight);
(slight breathlessness);
(moderate); 4 (some what severe);
5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum]); and 10 (maximum).
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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One Year Survival Probability From the Start of Sildenafil Treatment.
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Assessment method [4]
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The survival probability of all participants up to 1-year post start of Sildenafil treatment; for participants who were randomized to Sildenafil, this was the week 52 from randomization, and for participants who were originally randomized to Placebo group, this was the Week 64 from Baseline (Week 52 from Week 12, when the first dose of Sildenafil was administered to these participants). Those participants who discontinued from the study prior to 1 year after start of sildenafil were considered as censored at the time of discontinuation and those who discontinued from the study post 1-year after start of sildenafil were considered as censored at the time of 1-year post start of sildenafil.
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Timepoint [4]
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One year from the time of starting sildenafil
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Secondary outcome [5]
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One Year Survival From the Start of Sildenafil Treatment.
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Assessment method [5]
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The survival status of all participants who discontinued from the study, including those participants who discontinued during the double-blind phase, was to be assessed at one year post their Week 12 visit/ End of treatment visit.
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Timepoint [5]
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One year from the time of starting sildenafil
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Eligibility
Key inclusion criteria
- Subjects aged 18 and over above with PAH and for which bosentan therapy is indicated
according to national license
- Subjects with a mean pulmonary artery pressure of >25mmHg and a pulmonary artery wedge
pressure of <15mmHg at rest via right heart catheterization within 3 years prior to
randomization.
- Subjects whose baseline 6 Minute Walk Test distance is >100m and < 450m.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- PAH secondary to any aetiology including congenital heart disease other than those
specified in the inclusion criteria
- Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related
dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2013
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Sample size
Target
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Accrual to date
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Final
105
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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St. Vincents Hospital - Darlinghurst
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Recruitment hospital [2]
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The Prince Charles Hospital - Chermside
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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4032 - Chermside
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Michigan
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Country [3]
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United States of America
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State/province [3]
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Pennsylvania
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Czechia
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State/province [5]
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Praha 2
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Country [6]
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Czechia
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State/province [6]
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Praha 4
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Country [7]
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France
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State/province [7]
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Lille
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Country [8]
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France
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State/province [8]
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Vandoeuvre Les Nancy
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Country [9]
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Germany
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State/province [9]
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Berlin
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Germany
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Coburg
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Germany
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State/province [11]
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Essen
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Germany
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State/province [12]
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Giessen
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Germany
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State/province [13]
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Hannover
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Country [14]
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Germany
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State/province [14]
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Homburg
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Country [15]
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Germany
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State/province [15]
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Leipzig
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Country [16]
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Germany
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State/province [16]
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Muenchen
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Germany
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Nuernberg
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Germany
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State/province [18]
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Wuerzburg
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Greece
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Athens
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Israel
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State/province [20]
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Haifa
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Israel
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State/province [21]
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Petach Tikva
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Italy
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State/province [22]
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Napoli
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Italy
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State/province [23]
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Roma
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Country [24]
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Taiwan
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State/province [24]
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Taipei
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Country [25]
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United Kingdom
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State/province [25]
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Cambridgeshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To assess the efficacy and safety of sildenafil when added to patients with PAH who are
taking bosentan as all or part of their background therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00323297
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00323297
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