NCT00159913

A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.

A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (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

This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in three different doses, compared to placebo (inactive treatment). Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may be eligible to take part in an extension study, in which all patients will receive active treatment of sildenafil.

Conditions

• Pulmonary Arterial Hypertension, Children

Interventions

Type	Name	Description
DRUG	Sildenafil citrate	oral; 20mg, 40mg and 80 mg; 3 times a day(TID)
DRUG	Sildenafil citrate	oral; 10mg, 20mg and 40mg; 3 times a day(TID)
DRUG	Placebo	oral; 3 times a day(TID)
DRUG	Sildenafil citrate	oral; 10 mg; 3 times a day(TID)

Timeline

• Start date: 2003-08-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2005-09-12
• Last updated: 2021-02-18
• Results posted: 2009-07-21

Locations

41 sites across 17 countries: United States, Brazil, Canada, Chile, Colombia, Guatemala, Hungary, India, Italy, Japan, Malaysia, Mexico, Peru, Poland, Russia, Sweden, Taiwan