Korean AMADEUS Study

• Sponsor: The Catholic University of Korea (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01239849
• Collaborator: Pfizer (Industry)
• Enrollment: 500
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 20.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Hypercholessterolemia	Drug: Atorvastatin, 10mg, 20mg, 40mg	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Feb 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2010
• Anticipated Study Completion Date: Feb 1, 2011

Outcome Measures

Primary Outcome Measures

1. Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment. [8 weeks]

Secondary Outcome Measures

1. 1. Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 4 weeks of treatment. [8 weeks]

2. 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. [8 weeks]

3. 3. Percentage of subjects who achieved LDL cholesterol target with no titration of atorvastatin and after one step titration of atorvastatin [8 weeks]

4. 4. Change and percent change from baseline to 4 and 8 weeks of treatment for small dense LDL cholesterol, adiponectin, hs-CRP [8 weeks]

5. 5. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events. [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sung Rae Kim	Bucheon	Kyeongki	Korea, Republic of	420-717

Sponsors and Collaborators

• The Catholic University of Korea
• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01239849
• Other Study ID Numbers: SKimlipid
• First Posted: Nov 11, 2010
• Last Update Posted: Nov 15, 2010
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Diabetes Mellitus, Hypercholesterolemia
• Additional relevant MeSH terms: Diabetes Mellitus; Atorvastatin

Study Results

No Results Posted as of Nov 15, 2010