NCT00044460 - 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)

Abstract: The Effects of Rosiglitazone in Poorly-Controlled, Drug-Naive Patients with Type 2 Diabetes Mellitus, KATHLEEN L
WYNE, ALEXANDER R. COBITZ, BRIAN R. WATERHOUSE, LEANNE J. STROW. Dallas, TX; King of Prussia, PA; Orlando, FL; USA. 64th Annual Sci
Wyne KL, Cobitz AR, Waterhouse BR, Strow LJ
The effects of rosiglitazone in poorly-controlled drug-naive patients with type 2 diabetes mellitus. Diabetes 2004;53(Suppl 2):A152. Poster 639 presented at ADA

A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus

Details for clinical trial NCT00044460

Clinical trial NCT00044460 - References