Status:
UNKNOWN
Korean AMADEUS Study
Lead Sponsor:
The Catholic University of Korea
Collaborating Sponsors:
Pfizer
Conditions:
Diabetes Mellitus, Hypercholessterolemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Korean Diabetes Patients
- Is ≥ 18 and ≤ 80 years olds
- Has diagnosis of dyslipidemia
- Has 100 mg/dl ≤ LDL cholesterol ≤ 220 mg/dl
- Has triglyceride level ≤ 600 mg/dl
- Has HbA1c ≤ 12%
- If female, is postmenopausal, surgically sterilized, or using a reliable methods of birth control considered suitable by the investigator
- Can discontinue all current antilipidemic medication for the 4 week washout period
- Has provided written informed consent prior to the initiation of any study procedure
Exclusion
- Is pregnant or lactating
- Abuse alcohol and/or any other drug
- Uncontrolled diabetes ( HbA1c \> 12% )
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01239849
Start Date
February 1 2009
End Date
February 1 2011
Last Update
November 15 2010
Active Locations (1)
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1
Sung Rae Kim
Bucheon-si, Kyeongki, South Korea, 420-717