A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131
Abstract
Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.
Conditions: Pulmonary Arterial Hypertension.
Primary outcome: Number of Participants Reporting at Least One Adverse Event; Number of Participants Reporting Treatment-related Adverse Events; Number of Participants Reporting at Least One Serious Adverse Event; Number of Participants Reporting Treatment-related Serious Adverse Events; Number of Deaths Reported in the Study Prior to the Data Monitoring Committee (DMC) Recommendation of Dose Down Titration; Number of Deaths Reported During This Study; Discontinuation Due to Intolerability; Downtitration in Dose Due to Intolerability.; Number of Participants With Deterioration Post Baseline in Visual Acuity Safety Tests; Number of Participants With Deterioration Post Baseline in Color Vision Monitoring Safety Tests.; Pediatric Cognitive Development Status at Week 16.; Pediatric Cognitive Development Status at Week 52.; Pediatric Motor Development Status at Week 16.; Pediatric Motor Development Status at Week 52.
Enrollment: 234 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 234 participants or records.
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