Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study

NCT00540293

Last updated date
Study Location
Pfizer Investigational Site
Daegu, Korea, 705-717, Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dyslipidemias
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. Is a Korean , dyslipidemic outpatient

2. Is eligible for LDL-lowering drug therapy at screening and baseline as determined by the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP Ⅲ: 2. 1 LDL-C ≥ 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ≥ 160 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk < 10 % 2. 3 LDL-C ≥ 130 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C ≥ 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk > 20 %)

3. Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline

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


1. Is pregnant or lactating


2. Has present myopathy or history of myopathy or has personal or familial history of
hereditary muscular disorders or any history of rhabdomyolysis


3. Has history of intolerance or hypersensitivity to atorvastatin or other statins


4. Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg
and/or diastolic BP ≥ 100mmHg)


5. Has HbAlc > 10%


6. Has any severe disease of has had any major problem or surgical procedure within the 3
months prior to screening that is likely to jeopardize the planned termination of the
study. (e.g., any carcinoma, coronary angioplasty, coronary artery bypass graft,
cardiac infarct, severe or unstable angina pectoris)

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Advanced Information
Descriptive Information
Brief Title  ICMJE Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
Official Title  ICMJE A Multicenter, Eight-Week Treatment, Single-Step Titration Open-Label Study Assessing The Percentage Of Korean Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 MG, 20 MG, And 40 MG.
Brief Summary To evaluate the percentage of Korean dyslipidemic subjects in the total group and each cardiovascular risk group achieving LDL-C target as defined by NCEP ATP ? criteria at starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dyslipidemias
Intervention  ICMJE Drug: Atorvastatin
Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group
Study Arms  ICMJE Experimental: Treatment group
this patient group consists of dyslipidemia patients with various CVD risk factors
Intervention: Drug: Atorvastatin
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2009)
425
Original Enrollment  ICMJE
 (submitted: October 4, 2007)
416
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Is a Korean , dyslipidemic outpatient
  2. Is eligible for LDL-lowering drug therapy at screening and baseline as determined by the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP ?: 2. 1 LDL-C ? 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ? 160 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk < 10 % 2. 3 LDL-C ? 130 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C ? 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk > 20 %)
  3. Has LDL-C ? 220mg/dL at baseline 4. Has triglyceride level ? 600mg/dL at baseline

Exclusion Criteria:

  1. Is pregnant or lactating
  2. Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis
  3. Has history of intolerance or hypersensitivity to atorvastatin or other statins
  4. Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ? 160mmHg and/or diastolic BP ? 100mmHg)
  5. Has HbAlc > 10%
  6. Has any severe disease of has had any major problem or surgical procedure within the 3 months prior to screening that is likely to jeopardize the planned termination of the study. (e.g., any carcinoma, coronary angioplasty, coronary artery bypass graft, cardiac infarct, severe or unstable angina pectoris)
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 NCT00540293
Other Study ID Numbers  ICMJE A2581157
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2009

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