NCT00526058 - 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)

Julius U, Metzler W, Pietzsch J, Fassbender T, Klingel R
Intraindividual comparison of two extracorporeal LDL apheresis methods: lipidfiltration and HELP. Int J Artif Organs. 2002 Dec;25(12):1180-8.
Moriarty PM, Gibson CA, Shih J, Matias MS
C-reactive protein and other markers of inflammation among patients undergoing HELP LDL apheresis. Atherosclerosis. 2001 Oct;158(2):495-8.
Schettler V, Monazahian M, Wieland E, Thomssen R, Müller GA
Effect of heparin-induced extracorporeal low-density lipoprotein precipitation (HELP) apheresis on hepatitis C plasma virus load. Ther Apher. 2001 Oct;5(5):384-6.
Susca M
Heparin-Induced extracorporeal low-density lipoprotein precipitation futura, a new modification of HELP apheresis: technique and first clinical results. Ther Apher. 2001 Oct;5(5):387-93.

Randomized Multicenter Crossover Study to Compare the Plasmat® Futura Heparin Induced Extracorporeal Lower Density Lipo-Protein (LDL) Precipitation (H.E.L.P.) Apheresis System to the Approved Secura System in the Reduction of LDL-c in Patients With Hypercholesterolemia

Details for clinical trial NCT00526058

Clinical trial NCT00526058 - References