At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 267 enrolled
Drug / intervention
Sildenafil citratedrug
Likely dose
Sildenafil citrate 20, 40, or 80 mg three times daily (subject-optimised dose)AI-extracted
Key inclusion· 1
- ✓Pulmonary arterial hypertension (PAH) caused by primary PAH, connective tissue disease association, or following surgical repair of a congenital heart lesion
Key exclusion· 1
- ✕Pulmonary hypertension other than PAH
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Sep 12, 2005·Updated Feb 1, 2021
In Brief
A Phase 3 clinical trial evaluating Sildenafil citrate for Pulmonary Hypertension. Completed, enrolled 267 participants across 52 sites in 11 countries.
Detailed Summary
Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
CountriesBelgium, Canada, Czechia, Denmark, France, Israel, Italy, Netherlands, Spain, United Kingdom, United States
CollaboratorsPfizer
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2003
First PostedSep 2005
Study CompletionJan 2006
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartJul 1, 2003
Study CompletionJan 1, 2006
TodayJul 2, 2026
Posted 20.8 years ago
Interventions
Sildenafil citratedrug