Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature

Inclusion Criteria: * Informed consent obtained from subject's parents or legally acceptable representative before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) * Pre-pubertal status (males aged from 4 to 11 \[both inclusive\], females aged from 4 to 9 \[both inclusive\]): an absence of breast development in females (Tanner 1 only) and testicular volume below 4 mL in males * Growth hormone level above 10 ng/mL following a stimulation test (test result within 6 months from screening can be used) * Height below 3 percentile * Bone age below or equal to 12 year * Epiphyses confirmed as open in patients at least 10 years or more of age Exclusion Criteria: * Known presence of one or more pituitary hormone deficiencies (ACTH (adrenocorticotropic hormone), ADH (antidiuretic hormone), FSH (follicle-stimulating hormone), LH (luteinising hormone), TSH (thyroid-stimulating hormone)) * Known primary hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated) * Specific types of growth failure including, but not limited to, known chromosomal abnormalities associated with growth failure and altered sensitivity to growth hormone * Bone age is advanced over chronological age more than 3 years * Active malignancy, CNS (central nervous system) trauma, active chemotherapy or radiation therapy for neoplasia * Prior history of intracranial hypertension * Hypertrophic cardio…