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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
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)
Secondary ID [1] 0 0
2006-001464-23
Secondary ID [2] 0 0
A1481243
Universal Trial Number (UTN)
Trial acronym
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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12
Timepoint [1] 0 0
Week 12
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
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Clinical Worsening Events
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change From Baseline in Borg Dyspnea Score at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
One Year Survival Probability From the Start of Sildenafil Treatment.
Timepoint [4] 0 0
One year from the time of starting sildenafil
Secondary outcome [5] 0 0
One Year Survival From the Start of Sildenafil Treatment.
Timepoint [5] 0 0
One year from the time of starting sildenafil

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
St. Vincents Hospital - Darlinghurst
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Czechia
State/province [5] 0 0
Praha 2
Country [6] 0 0
Czechia
State/province [6] 0 0
Praha 4
Country [7] 0 0
France
State/province [7] 0 0
Lille
Country [8] 0 0
France
State/province [8] 0 0
Vandoeuvre Les Nancy
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Coburg
Country [11] 0 0
Germany
State/province [11] 0 0
Essen
Country [12] 0 0
Germany
State/province [12] 0 0
Giessen
Country [13] 0 0
Germany
State/province [13] 0 0
Hannover
Country [14] 0 0
Germany
State/province [14] 0 0
Homburg
Country [15] 0 0
Germany
State/province [15] 0 0
Leipzig
Country [16] 0 0
Germany
State/province [16] 0 0
Muenchen
Country [17] 0 0
Germany
State/province [17] 0 0
Nuernberg
Country [18] 0 0
Germany
State/province [18] 0 0
Wuerzburg
Country [19] 0 0
Greece
State/province [19] 0 0
Athens
Country [20] 0 0
Israel
State/province [20] 0 0
Haifa
Country [21] 0 0
Israel
State/province [21] 0 0
Petach Tikva
Country [22] 0 0
Italy
State/province [22] 0 0
Napoli
Country [23] 0 0
Italy
State/province [23] 0 0
Roma
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taipei
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Cambridgeshire

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 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.
Trial website
https://clinicaltrials.gov/study/NCT00323297
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.
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/NCT00323297