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Korean AMADEUS Study

NCT01239849 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2010-11-15

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Hypercholessterolemia

Interventions

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • The Catholic University of Korea

    lead OTHER

Principal Investigators

  • SUNG RAE KIM, A. Professor · Bucheon St. Mary Hospital, The Catholic University of Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-12-31
Completion
2011-02-28

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01239849 on ClinicalTrials.gov