Korean AMADEUS Study

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. Identifier: NCT01239849
Recruitment Status : Unknown
Verified February 2009 by The Catholic University of Korea.
Recruitment status was:  Recruiting
First Posted : November 11, 2010
Last Update Posted : November 15, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Hypercholessterolemia Drug: Atorvastatin, 10mg, 20mg, 40mg Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : February 2011

Intervention Details:
  • 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

Primary Outcome Measures :
  1. Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. 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. 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. 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. 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. 5. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events. [ Time Frame: 8 weeks ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01239849

Contact: SUNG RAE KIM, A. Professor +82-32-340-2025

Korea, Republic of
Sung Rae Kim Recruiting
Bucheon, Kyeongki, Korea, Republic of, 420-717
Contact: SUNG RAE KIM, A. Professor    +82-32-340-2025   
Principal Investigator: JAE HYUNG CHO, Professor         
Principal Investigator: KI HO SONG, Professor         
Principal Investigator: SEUNG JUN OH, Professor         
Principal Investigator: HYE SOON KIM, Professor         
Principal Investigator: KYUNG MOOK CHOI, Professor         
Principal Investigator: IN JOO KIM, Professor         
Principal Investigator: SOO KYOUNG KIM, Professor         
Principal Investigator: SUNG HEE CHOI, Professor         
Principal Investigator: JONG WHA KIM, Professor         
Principal Investigator: CHAN HEE JUNG, Professor         
Principal Investigator: MIN KYOUNG MOON, Professor         
Principal Investigator: HYE JIN KIM, Professor         
Principal Investigator: YOUNG IL KIM, Professor         
Principal Investigator: KANG SEO PARK, Professor         
Principal Investigator: DONG JOON KIM, Professor         
Principal Investigator: SANG YOUNG KIM, Professor         
Principal Investigator: CHANG BUM LEE, Professor         
Sponsors and Collaborators
The Catholic University of Korea
Principal Investigator: SUNG RAE KIM, A. Professor Bucheon St. Mary Hospital, The Catholic University of Korea

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bucheon St Mary Hospital, The Catholic University of Korea Identifier: NCT01239849     History of Changes
Other Study ID Numbers: SKimlipid
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: November 15, 2010
Last Verified: February 2009

Keywords provided by The Catholic University of Korea:
Diabetes Mellitus, Hypercholesterolemia

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors