A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS)
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group
controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects
will be treated with 0.067 milligram/kilogram/day (mg/kg/day) of Saizen®, weight base dose,
for 12 months (12 months of treatment in the test group, and 6 months of no treatment and
then 6 months of treatment in the control group).