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Korean AMADEUS Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by The Catholic University of Korea.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: November 11, 2010
Last Update Posted: November 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Catholic University of Korea
November 10, 2010
November 11, 2010
November 15, 2010
February 2009
December 2010   (Final data collection date for primary outcome measure)
Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment. [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT01239849 on ClinicalTrials.gov Archive Site
  • 1. Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 4 weeks of treatment. [ Time Frame: 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. [ Time Frame: 8 weeks ]
  • 3. Percentage of subjects who achieved LDL cholesterol target with no titration of atorvastatin and after one step titration of atorvastatin [ Time Frame: 8 weeks ]
  • 4. Change and percent change from baseline to 4 and 8 weeks of treatment for small dense LDL cholesterol, adiponectin, hs-CRP [ Time Frame: 8 weeks ]
  • 5. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events. [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
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
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.
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Hypercholessterolemia
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

Not Provided
Son JW, Kim DJ, Lee CB, Oh S, Song KH, Jung CH, Mok JO, Kim JH, Moon MK, Choi KM, Cho JH, Choi SH, Kim SK, Park KS, Kim HS, Kim IJ, Kim YI, Kim HJ, Kim SY, Kim S. Effects of patient-tailored atorvastatin therapy on ameliorating the levels of atherogenic lipids and inflammation beyond lowering low-density lipoprotein cholesterol in patients with type 2 diabetes. J Diabetes Investig. 2013 Sep 13;4(5):466-74. doi: 10.1111/jdi.12074. Epub 2013 Mar 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
February 2011
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Bucheon St Mary Hospital, The Catholic University of Korea
The Catholic University of Korea
Principal Investigator: SUNG RAE KIM, A. Professor Bucheon St. Mary Hospital, The Catholic University of Korea
The Catholic University of Korea
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP