Korean AMADEUS Study

Phase 4

• Conditions: Diabetes Mellitus, Hypercholessterolemia

• Registration Number: NCT01239849
• Lead Sponsor: The Catholic University of Korea

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-02
• Study Start: 2009-02
• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Last Update Submitted: 2010-11-12
• Last Update Posted: 2010-11-15
• Primary Completion: 2010-12
• Study Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Korean Diabetes Patients
2. Is ≥ 18 and ≤ 80 years olds
3. Has diagnosis of dyslipidemia
4. Has 100 mg/dl ≤ LDL cholesterol ≤ 220 mg/dl
5. Has triglyceride level ≤ 600 mg/dl
6. Has HbA1c ≤ 12%
7. If female, is postmenopausal, surgically sterilized, or using a reliable methods of birth control considered suitable by the investigator
8. Can discontinue all current antilipidemic medication for the 4 week washout period
9. Has provided written informed consent prior to the initiation of any study procedure

Exclusion Criteria

1. Is pregnant or lactating
2. Abuse alcohol and/or any other drug
3. Uncontrolled diabetes ( HbA1c > 12% )
4. Has impaired hepatic function, as shown by but not limited to alanine aminotransferase (ALT,SGOT) or aspartate aminotransferase (AST, SGOT) ≥ 2times the upper limit of normal at baseline.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment.	8 weeks

Secondary Outcome Measures

Name	Time	Method
1. Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 4 weeks of treatment.	8 weeks
2. Change and percent change from baseline to 4 and 8 weeks of treatment for LDL cholesterol, HDL cholesterol, non-HDL cholesterol, LDL cholesterol/HDL cholesterol ratio, Total cholesterol, Triglyceride subjects in the total group.	8 weeks
3. Percentage of subjects who achieved LDL cholesterol target with no titration of atorvastatin and after one step titration of atorvastatin	8 weeks
4. Change and percent change from baseline to 4 and 8 weeks of treatment for small dense LDL cholesterol, adiponectin, hs-CRP	8 weeks
5. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events.	8 weeks

Trial Locations

Locations (1)

Sung Rae Kim; 🇰🇷 Bucheon, Kyeongki, Korea, Republic of