NCT00159874

A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Sildenafil citrate	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)
DRUG	Sildenafil citrate	Oral,10 mg 3 times a day (tid), only subjects with body weight \>20 kg
DRUG	Sildenafil citrate	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)

Timeline

• Start date: 2004-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2005-09-12
• Last updated: 2021-02-01
• Results posted: 2014-08-11

Locations

39 sites across 15 countries: United States, Brazil, Chile, Colombia, Guatemala, Hungary, India, Italy, Japan, Malaysia, Mexico, Poland, Russia, Sweden, Taiwan