At a glance
ClinicalIndex Comparison Record- ✓Age 1–17 years, weight ≥8 kg with hemodynamically confirmed PAH (mPAP ≥25 mmHg, PCWP ≤15 mmHg, PVRI ≥3 Wood units × m²)
- ✓PAH due to: primary pulmonary hypertension; small/hemodynamically insignificant shunt; collagen vascular disease; unrepaired or repaired congenital shunt (≥6 months prior, O₂ sat ≥88%); d-TGA repaired within 30 days of life; or other repaired congenital heart lesion (≥6 months prior) without significant residual left heart disease
- ✓If exercise-capable: Peak VO₂ 10–28 mL/kg/min on cardiopulmonary exercise test during screening
- ✓No altitude shifts >5000 feet during study, or if relocated, ≥90 days at new altitude prior to baseline
- ✕PAH secondary to sickle cell disease or etiology other than those specified in inclusion criteria
- ✕Significant left heart disease: valve disease >mild, restrictive or congestive cardiomyopathy, PCWP/LVEDP >15 mmHg, LVEF <40%, LV shortening fraction <22%, or symptomatic coronary disease
- ✕Hemodynamic instability: SBP outside 70–140 mmHg at screening
- ✕Stroke, myocardial infarction, or life-threatening arrhythmia within 6 months of screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Sildenafil citrate and Placebo for Pulmonary Arterial Hypertension, Children. Completed, enrolled 235 participants across 41 sites in 17 countries.
Detailed 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.
Study Details
Timeline
Interventions
oral; 20mg, 40mg and 80 mg; 3 times a day(TID)
oral; 10mg, 20mg and 40mg; 3 times a day(TID)
oral; 3 times a day(TID)
oral; 10 mg; 3 times a day(TID)