CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 234 enrolled
Drug / intervention
Sildenafil citrate +2 moredrug
Likely dose
Sildenafil citrate 10–80 mg orally three times daily (weight-based: 8–20 kg: 10–20 mg; 20–45 kg: 20–40 mg; >45 kg: 40–80 mg)AI-extracted
Key inclusion· 1
  • ✓Completion of 16-week double-blind efficacy study A1481131
Key exclusion· 1
  • ✕Did not complete study A1481131

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00159874
NCT00159874Phase 3Completed
CompareCT.gov

A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131

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 Arterial Hypertension. Completed, enrolled 234 participants across 39 sites in 15 countries.

Detailed Summary

Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesBrazil, Chile, Colombia, Guatemala, Hungary, India, Italy, Japan, Malaysia, Mexico, Poland, Russia, Sweden, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartJan 1, 2004
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 20.8 years ago

Interventions

Sildenafil citratedrug

Oral, subjects with body weight ≥8 - 20 kg: 20 mg 3 times a day (tid) subjects with body weight \>20 - 45 kg: 40 mg 3 times a day (tid) subjects with body weight \>45 kg: 80 mg 3 times a day (tid)

Sildenafil citratedrug

Oral,10 mg 3 times a day (tid), only subjects with body weight \>20 kg

Sildenafil citratedrug

Oral, subjects with body weight ≥8 - 20 kg: 10 mg 3 times a day (tid); subjects with body weight \>20 - 45 kg: 20 mg 3 times a day (tid); subjects with body weight \>45 kg: 40 mg 3 times a day (tid)