NCT01422317 - 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)

Bønaa KH, Bjerve KS, Straume B, Gram IT, Thelle D
Effect of eicosapentaenoic and docosahexaenoic acids on blood pressure in hypertension. A population-based intervention trial from the Tromsø study. N Engl J Med. 1990 Mar 22;322(12):795-801.
Connor SL, Connor WE
Are fish oils beneficial in the prevention and treatment of coronary artery disease? Am J Clin Nutr. 1997 Oct;66(4 Suppl):1020S-1031S. Review.
Eritsland J, Arnesen H, Seljeflot I, Høstmark AT
Long-term metabolic effects of n-3 polyunsaturated fatty acids in patients with coronary artery disease. Am J Clin Nutr. 1995 Apr;61(4):831-6.
Harris WS
Fish oils and plasma lipid and lipoprotein metabolism in humans: a critical review. J Lipid Res. 1989 Jun;30(6):785-807. Review.
Jeppesen J, Hein HO, Suadicani P, Gyntelberg F
Triglyceride concentration and ischemic heart disease: an eight-year follow-up in the Copenhagen Male Study. Circulation. 1998 Mar 24;97(11):1029-36. Erratum in: Circulation 1998 May 19;97(19):1995.
Leaf A, Weber PC
Cardiovascular effects of n-3 fatty acids. N Engl J Med. 1988 Mar 3;318(9):549-57. Review.
Schmidt EB, Dyerberg J
Omega-3 fatty acids. Current status in cardiovascular medicine. Drugs. 1994 Mar;47(3):405-24. Review.
Sellmayer A, Witzgall H, Lorenz RL, Weber PC
Effects of dietary fish oil on ventricular premature complexes. Am J Cardiol. 1995 Nov 1;76(12):974-7.

Effects of a High-dose Concentrate of n-3 Fatty Acids or Corn Oil Introduced Early After an Acute Myocardial Infarction on Serum Triacylglycerol and High-density Lipoprotein (HDL)- Cholesterol

Details for clinical trial NCT01422317

Clinical trial NCT01422317 - References