Phase 3
N=267
The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH
Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00159861 ↗Enrolled (actual)
267
Serious AEs
77.0%
Results posted
Jan 2011
Primary outcome: Primary: Categorized Change From Baseline in 6-Minute Walking Distance — 27; 46; 20; 26 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sildenafil citrate (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Categorized Change From Baseline in 6-Minute Walking Distance |
27; 46; 20; 26; 23; 15 | — |
| SECONDARY Survival Status |
24; 205; 36; 48; 169; 48 | — |
| SECONDARY Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class |
2; 3; 27; 46; 59; 57 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) |
10.5; 14.8; 9.7; 12.5; 8.9; 14.0 | — |
| SECONDARY Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score |
0.0505; 0.0473; 0.0489; 0.0483; -0.0278; 0.0770 | — |
| SECONDARY Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score |
6.8; 12.8; 5.5; 11.2; 4.7; 11.5 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score |
2; 9; 5; 4; 5; 2 | — |
| SECONDARY Change From Baseline in BORG Dyspnea Score |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Summary
Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension
Eligibility Criteria
Inclusion Criteria
- Patients with pulmonary arterial hypertension caused by primary PAH, associated with connective tissue disease or following surgical repair of a congenital heart lesion
Exclusion Criteria
- PH other than PAH
Data sourced from ClinicalTrials.gov (NCT00159861). 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.