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Korean AMADEUS Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by The Catholic University of Korea.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01239849
First received: November 10, 2010
Last updated: November 12, 2010
Last verified: February 2009
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Hypercholessterolemia
 Drug: Atorvastatin, 10mg, 20mg, 40mg
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Diabetes
U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 4 weeks of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 5. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239849

Contacts
Contact: SUNG RAE KIM, A. Professor +82-32-340-2025 kimsungrae@catholic.ac.kr

Locations
Korea, Republic of
Sung Rae Kim Recruiting
Bucheon, Kyeongki, Korea, Republic of, 420-717
Contact: SUNG RAE KIM, A. Professor     +82-32-340-2025     kimsungrae@catholic.ac.kr    
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
Pfizer
Investigators
Principal Investigator: SUNG RAE KIM, A. Professor Bucheon St. Mary Hospital, The Catholic University of Korea
  More Information

No publications provided

Responsible Party: Bucheon St Mary Hospital, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01239849     History of Changes
Other Study ID Numbers: SKimlipid
Study First Received: November 10, 2010
Last Updated: November 12, 2010
Health Authority: Korea: Food and Drug Administration

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013