drugset / Trial / NCT01157793

A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood

NCT01157793

Phase 4 Completed 34 enrolled Merck KGaA, Darmstadt, Germany
RandomizedParallel-groupOpen-labelTreatment

Summary

This was a 48-week, open-label, prospective, multicentric, randomised, comparative with parallel control, Phase 4 study to evaluate the effects of Saizen on cardiac function in GHD subjects during the transition phase from childhood to adulthood. The study was designed to evaluate whether recombinant-human growth hormone (r-hGH) treatment also benefits young subjects with GHD. Some trials have already been published on this subject, but they were mainly focused on the bone density.

Timeline

Start
2003-09
Primary completion
2005-02
Completion
2005-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatropin Protein / enzyme biologic 1 mg Subcutaneous

Indications