NCT01239849

Korean AMADEUS Study

A Multicenter, Eight Weeks Treatment, Single Step Titration, Open Label Study Assessing the Percentage of Korean Diabetic Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Dose 10mg, 20mg, 40mg

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Hypercholessterolemia

Interventions

Type	Name	Description
DRUG	Atorvastatin, 10mg, 20mg, 40mg	If initial LDL cholesterol between 100\~ 129mg/dl then starting dose of Atorvastatin is 10mg, 130\~159 mg/dl is 20 mg, 160\~220mg/dl is 40mg. After 4weeks treatment, if LDL cholesterol is below 100mg/dl then continue starting dose and if not reach below 100mg/dl then titration double dose. After 4 weeks treatment, recheck the LDL cholesterol

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-12-01
• Completion: 2011-02-01
• First posted: 2010-11-11
• Last updated: 2010-11-15

Locations

1 site across 1 country: South Korea