NCT00154206 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Niaudet P, Charbit M, Loirat C, Lapeyraque AL, Tsimaratos M, Cailliez M, Foulard M, Dehennault M, Marquet P, Chaouche-Teyara K, Lemay D
Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients. Pediatr Nephrol. 2009 Feb;24(2):395-402. doi: 10.1007/s00467-008-1031-7.

A Multicenter, Open, Single Arm, Pilot Study to Evaluate Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients

Details for clinical trial NCT00154206

Clinical trial NCT00154206 - References