Korean AMADEUS Study

November 12, 2010 updated by: The Catholic University of Korea

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Kyeongki
      • Bucheon, Kyeongki, Korea, Republic of, 420-717
        • Recruiting
        • Sung Rae Kim
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
1. Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 4 weeks of treatment.
Time Frame: 8 weeks
8 weeks
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
8 weeks
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
8 weeks
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
8 weeks
5. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Collaborators

Pfizer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 12, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKimlipid

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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