Conditions: Pulmonary Arterial Hypertension
Keywords: children
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 234
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: As per Protocol Amendment 8 (Aug 2011), all doses in the high dose treatment group were discontinued. Subjects who were receiving these doses and continued in the study were requested to down titrate. arm 2: None arm 3: As per Protocol Amendment 8 (August 2011), the dose 40 mg TID in the medium dose treatment group was discontinued. Subjects who were receiving this dose and continued in the study were requested to down titrate.

Interventions: intervention 1: Sildenafil citrate intervention 2: Sildenafil citrate intervention 3: Sildenafil citrate
Intervention descriptions: intervention 1: 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) intervention 2: Oral,10 mg 3 times a day (tid), only subjects with body weight \>20 kg intervention 3: 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)

Protocol document: