Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Registration Number
- NCT00323297
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Bosentan - Active Sildenafil Citrate - placebo Placebo - placebo Bosentan -
- Primary Outcome Measures
Name Time Method Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12 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.
- Secondary Outcome Measures
Name Time Method One Year Survival From the Start of Sildenafil Treatment. One year from the time of starting sildenafil 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.
Clinical Worsening Events Week 12 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.Change From Baseline in Borg Dyspnea Score at Week 12 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).Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF Week 12 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.
One Year Survival Probability From the Start of Sildenafil Treatment. One year from the time of starting sildenafil 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.
Trial Locations
- Locations (30)
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
West Los Angeles VA Healthcare, Pulmonary Hypertension Program
🇺🇸Los Angeles, California, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
St. Vincents Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Clinique des Maladies Respiratoires
🇫🇷Lille, France
Hopital Claude Huriez
🇫🇷Lille, France
Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin
🇩🇪Berlin, Germany
II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie
🇩🇪Coburg, Germany
Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie
🇩🇪Essen, Germany
Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen
🇩🇪Giessen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitaetsklinikum des Saarlandes, Innere Medizin V
🇩🇪Homburg, Germany
Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Praxis fuer Innere Medizin, Kardiologie und Angiologie
🇩🇪Nuernberg, Germany
Med. Klinik u. Poliklinik I der LMU Muenchen, Klinikum Grosshadern
🇩🇪Muenchen, Germany
Missionsaerztliche Klinik Wuerzburg, Gemeinnuetzige Gesellschaft mbH
🇩🇪Wuerzburg, Germany
Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari
🇮🇹Roma, Italy
Hopital Adules Brabois
🇫🇷Vandoeuvre Les Nancy, France
Cardiologia, Azienda Ospedaliera Monaldi, Seconda Università di Napoli
🇮🇹Napoli, Italy
Attikon Hospital
🇬🇷Haidari, Athens, Greece
PVDU
🇬🇧Papworth Everard, Cambridgeshire, United Kingdom
Rambam Medical Center
🇮🇱Haifa, Israel
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Department of Surgery, National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Rabin Medical Centre
🇮🇱Petach Tikva, Israel
Institut klinicke a experimentalni mediciny, Klinika kardiologie
🇨🇿Praha 4, Czechia