NCT00412386 - 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)

Fernandes SM, Sanders SP, Khairy P, Jenkins KJ, Gauvreau K, Lang P, Simonds H, Colan SD
Morphology of bicuspid aortic valve in children and adolescents. J Am Coll Cardiol. 2004 Oct 19;44(8):1648-51.
Karakaya O, Barutcu I, Esen AM, Dogan S, Saglam M, Karapinar H, Akgun T, Karavelioglu Y, Esen O, Ozdemir N, Turkmen S, Kaymaz C
Relationship between circulating plasma matrix metalloproteinase-9 (gelatinase-B) concentration and aortic root dilatation. Am J Hypertens. 2006 Apr;19(4):361-5.
Novaro GM, Tiong IY, Pearce GL, Grimm RA, Smedira N, Griffin BP
Features and predictors of ascending aortic dilatation in association with a congenital bicuspid aortic valve. Am J Cardiol. 2003 Jul 1;92(1):99-101.
Robicsek F, Thubrikar MJ, Cook JW, Fowler B
The congenitally bicuspid aortic valve: how does it function? Why does it fail? Ann Thorac Surg. 2004 Jan;77(1):177-85.

Abnormal 3-dimensional MRI Flow Patterns and Plasma Matrix Metalloproteinase Levels Predict Dilatation of Ascending Aorta in Adolescent Patients With Bicuspid Aortic Valve

Details for clinical trial NCT00412386

Clinical trial NCT00412386 - References