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Korean AMADEUS Study

NCT ID: NCT01239849

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Hypercholessterolemia

Keywords

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Diabetes Mellitus, Hypercholesterolemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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The Catholic University of Korea

Principal Investigators

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SUNG RAE KIM, A. Professor

Role: PRINCIPAL_INVESTIGATOR

Bucheon St. Mary Hospital, The Catholic University of Korea

Locations

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Sung Rae Kim

Bucheon-si, Kyeongki, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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SUNG RAE KIM, A. Professor

Role: CONTACT

Phone: +82-32-340-2025

Email: [email protected]

Facility Contacts

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SUNG RAE KIM, A. Professor

Role: primary

References

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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.

Reference Type DERIVED
PMID: 24843697 (View on PubMed)

Other Identifiers

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SKimlipid

Identifier Type: -

Identifier Source: org_study_id