NCT01160536 - 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)

Codori AM, Zawacki KL, Petersen GM, Miglioretti DL, Bacon JA, Trimbath JD, Booker SV, Picarello K, Giardiello FM
Genetic testing for hereditary colorectal cancer in children: long-term psychological effects. Am J Med Genet A. 2003 Jan 15;116A(2):117-28.
Coffey JS
Parenting a child with chronic illness: a metasynthesis. Pediatr Nurs. 2006 Jan-Feb;32(1):51-9.
Haga SB, Terry SF
Ensuring the safe use of genomic medicine in children. Clin Pediatr (Phila). 2009 Sep;48(7):703-8. doi: 10.1177/0009922809335736. Epub 2009 May 15.

The Perceived Impact of Children s Risk Status for Hypertrophic Cardiomyopathy on Families: An Exploratory Study

Clinical trial NCT01160536 - References