drugset / Trial / NCT01239849

Korean AMADEUS Study

NCT01239849 ↗

Phase 4 Unknown 500 enrolled The Catholic University of Korea Pfizer · collab
NaSingle-groupOpen-labelTreatment

Summary

Because Diabetes Mellitus is one of the major risk factors for CV disease and lots of related evidences have been published including CARDS study that showed definite benefit of statin treatment in DM patients and influenced ADA guideline. \& NCEP ATP III update. However, there are large unmet medical needs for DM patients who don't reach their target LDL-C level defined NCEPT ATP III update because of physicians usually start with the lowest dose of statin and then titrate to the goal. Thus, we are curious about changing our prescription pattern into more tailored way; selecting starting dose based on the individual risk factors and concomitant status will impact the goal achieving rate for DM patients. Besides that, we are going to find out preliminary data about other markers change; small dense LDL and adiponectine;. Small dense LDL-C is more inflammatory and atherogenic LDL-C that may explain the impact of triglyceride. Adiponectin is another good marker related with obesity and metabolic syndrome.

Timeline

Start
2009-02
Primary completion
2010-12
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 10 mg —
Subject Atorvastatin Small molecule 20 mg —
Subject Atorvastatin Small molecule 40 mg —

Indications