NCT00166153 - 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)

Dipchand AI, Pietra B, McCrindle BW, Rosebrook-Bicknell HL, Boucek MM
Mycophenolic acid levels in pediatric heart transplant recipients receiving mycophenolate mofetil. J Heart Lung Transplant. 2001 Oct;20(10):1035-43.
Keck BM, Bennett LE, Rosendale J, Daily OP, Novick RJ, Hosenpud JD
Worldwide thoracic organ transplantation: a report from the UNOS/ISHLT International Registry for Thoracic Organ Transplantation. Clin Transpl. 1999:35-49.
Laks H, Marelli D, Odim J, Fazio D
Heart transplantation in the young and elderly. Heart Fail Rev. 2001 Sep;6(3):221-6.
Morissette P, Albert C, Busque S, St-Louis G, Vinet B
In vivo higher glucuronidation of mycophenolic acid in male than in female recipients of a cadaveric kidney allograft and under immunosuppressive therapy with mycophenolate mofetil. Ther Drug Monit. 2001 Oct;23(5):520-5.
Sarris GE, Smith JA, Bernstein D, Griffin ML, Pitlick PT, Baum D, Billingham ME, Oyer PE, Stinson EB, Starnes VA, et al
Pediatric cardiac transplantation. The Stanford experience. Circulation. 1994 Nov;90(5 Pt 2):II51-5.

The Relationships Between Mycophenolic Acid Levels, T-Cell Subsets and Outcomes in Pediatric Heat Transplant Recipients Receiving Mycophenolate Mofetil (Cellcept)

Details for clinical trial NCT00166153

Clinical trial NCT00166153 - References