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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12
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.
Time frame: Week 12
Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF
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.
Time frame: Week 12
Clinical Worsening Events
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.
Time frame: Week 12
Change From Baseline in Borg Dyspnea Score at Week 12
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).
Time frame: Week 12
One Year Survival Probability From the Start of Sildenafil Treatment.
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Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
West Los Angeles VA Healthcare, Pulmonary Hypertension Program
Los Angeles, California, United States
Henry Ford Hospital
Detroit, Michigan, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
St. Vincents Hospital
Darlinghurst, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Institut klinicke a experimentalni mediciny, Klinika kardiologie
Prague, Czechia
...and 20 more locations
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.
Time frame: One year from the time of starting sildenafil
One Year Survival From the Start of Sildenafil Treatment.
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.
Time frame: One year from the time of starting sildenafil