Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
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)
Query!
Secondary ID [1]
0
0
2006-001464-23
Query!
Secondary ID [2]
0
0
A1481243
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Cardiovascular
0
0
0
0
Query!
Hypertension
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [1]
0
0
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [2]
0
0
Clinical Worsening Events
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 12
Query!
Secondary outcome [3]
0
0
Change From Baseline in Borg Dyspnea Score at Week 12
Query!
Assessment method [3]
0
0
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 \[just noticeable\]);
1. (very slight);
2. (slight breathlessness);
3. (moderate); 4 (some what severe);
5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe \[almost maximum\]); and 10 (maximum).
Query!
Timepoint [3]
0
0
Week 12
Query!
Secondary outcome [4]
0
0
One Year Survival Probability From the Start of Sildenafil Treatment.
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
One year from the time of starting sildenafil
Query!
Secondary outcome [5]
0
0
One Year Survival From the Start of Sildenafil Treatment.
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
One year from the time of starting sildenafil
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/08/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
105
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment hospital [1]
0
0
St. Vincents Hospital - Darlinghurst
Query!
Recruitment hospital [2]
0
0
The Prince Charles Hospital - Chermside
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
4032 - Chermside
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Michigan
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Pennsylvania
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Texas
Query!
Country [5]
0
0
Czechia
Query!
State/province [5]
0
0
Praha 2
Query!
Country [6]
0
0
Czechia
Query!
State/province [6]
0
0
Praha 4
Query!
Country [7]
0
0
France
Query!
State/province [7]
0
0
Lille
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Vandoeuvre Les Nancy
Query!
Country [9]
0
0
Germany
Query!
State/province [9]
0
0
Berlin
Query!
Country [10]
0
0
Germany
Query!
State/province [10]
0
0
Coburg
Query!
Country [11]
0
0
Germany
Query!
State/province [11]
0
0
Essen
Query!
Country [12]
0
0
Germany
Query!
State/province [12]
0
0
Giessen
Query!
Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Hannover
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Homburg
Query!
Country [15]
0
0
Germany
Query!
State/province [15]
0
0
Leipzig
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Muenchen
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Nuernberg
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Wuerzburg
Query!
Country [19]
0
0
Greece
Query!
State/province [19]
0
0
Athens
Query!
Country [20]
0
0
Israel
Query!
State/province [20]
0
0
Haifa
Query!
Country [21]
0
0
Israel
Query!
State/province [21]
0
0
Petach Tikva
Query!
Country [22]
0
0
Italy
Query!
State/province [22]
0
0
Napoli
Query!
Country [23]
0
0
Italy
Query!
State/province [23]
0
0
Roma
Query!
Country [24]
0
0
Taiwan
Query!
State/province [24]
0
0
Taipei
Query!
Country [25]
0
0
United Kingdom
Query!
State/province [25]
0
0
Cambridgeshire
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00323297
Query!
Trial related presentations / publications
Vizza CD, Jansa P, Teal S, Dombi T, Zhou D. Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial. BMC Cardiovasc Disord. 2017 Sep 6;17(1):239. doi: 10.1186/s12872-017-0674-3.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00323297
Download to PDF