Korean AMADEUS Study

NCT01239849

Last updated date
Study Location
Sung Rae Kim
Bucheon, Kyeongki, 420-717, Korea, Republic of
Contact
+82-32-340-2025

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholessterolemia Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Hypercholessterolemia Diabetes MellitusKorean AMADEUS Study
NCT01239849
  1. Bucheon, Kyeongki
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Korean AMADEUS Study
Official Title  ICMJE 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
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 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Hypercholessterolemia
Intervention  ICMJE 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

Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 10, 2010)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2011
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01239849
Other Study ID Numbers  ICMJE SKimlipid
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bucheon St Mary Hospital, The Catholic University of Korea
Study Sponsor  ICMJE The Catholic University of Korea
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:SUNG RAE KIM, A. ProfessorBucheon St. Mary Hospital, The Catholic University of Korea
PRS Account The Catholic University of Korea
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP