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

November 10, 2010
November 12, 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 ] [ Designated as safety issue: No ]
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 ] [ 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 ]
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
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
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.
Both
18 Years to 80 Years
No
Contact: SUNG RAE KIM, A. Professor +82-32-340-2025 kimsungrae@catholic.ac.kr
Korea, Republic of
 
NCT01239849
SKimlipid
Yes
Bucheon St Mary Hospital, The Catholic University of Korea
The Catholic University of Korea
Pfizer
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