Phase 4
Completed N=103
Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT00323297 ↗Enrolled (actual)
103
Serious AEs
43.7%
Results posted
Nov 2013
Primary outcomePrimary: Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12 — 17.42; 14.08; 14.08; 13.62 Meters — p=0.5802
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12 |
17.42; 14.08; 14.08; 13.62 | 0.5802 |
| SECONDARY Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF |
0; 0; 1; 0; 45; 39 | — |
| SECONDARY Clinical Worsening Events |
51; 47; 0; 1; 0; 0 | — |
| SECONDARY Change From Baseline in Borg Dyspnea Score at Week 12 |
0.16; -0.73; 0.24; -0.62 | — |
| SECONDARY One Year Survival Probability From the Start of Sildenafil Treatment. |
0.042; 0.040 | — |
| SECONDARY One Year Survival From the Start of Sildenafil Treatment. |
2; 2 | — |
Eligibility Criteria
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 100m and < 450m.
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.
Data sourced from ClinicalTrials.gov (NCT00323297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.