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Trial record 1 of 1 for:    NCT00540293
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Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study (AT GOAL)

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ClinicalTrials.gov Identifier: NCT00540293
Recruitment Status : Completed
First Posted : October 8, 2007
Results First Posted : June 26, 2009
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 4, 2007
First Posted Date  ICMJE October 8, 2007
Results First Submitted Date  ICMJE May 8, 2009
Results First Posted Date  ICMJE June 26, 2009
Last Update Posted Date August 25, 2009
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2009)
Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. [ Time Frame: Week 8 ]
LDL-C Responders by visit and by risk group - full analysis set (FAS)
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2007)
The primary endpoint is the percentage of subjects achieving their LDL-C target after 8 weeks of treatment. This endpoint will be assessed for subjects in the total group and repeated for subjects in each cardiovascular risk subgroup.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
  • Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment. [ Time Frame: Week 4 ]
    LDL-C Responders by visit and by risk group - FAS
  • Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment [ Time Frame: Weeks 4 and 8 ]
    Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride
  • Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment [ Time Frame: weeks 4 and 8 ]
    Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride
  • Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. [ Time Frame: 8 weeks ]
    LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
  • Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. [ Time Frame: 8 weeks ]
    LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
  • Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment [ Time Frame: 4 and 8 weeks ]
    Median baseline, and change from baseline in hs-CRP by risk group - FAS
  • Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment [ Time Frame: 4 and 8 weeks ]
    Percent change from baseline in hs-CRP by risk group - FAS
  • Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. [ Time Frame: Baseline, and 8 weeks ]
    Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS
  • Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. [ Time Frame: 8 weeks ]
    Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2007)
  • 1. Percentage of subjects in the total group and each cardiovascular risk group achieving their LDL-C target after 4 weeks of treatment.
  • 2. Change and percent change from baseline to 4 and 8 weeks of treatment for LDL-C, HDL-C, non-HDL-C, LDL-C/HDL-C ratio, TC, and TG for subjects in the total group and each cardiovascular risk group.
  • 3. Percentage of subjects who achieved LDL-C target with no titration of atorvastatin and after one step titration of atorvastatin.
  • 4. Change and percent change from baseline to 4 and 8 weeks of treatment for hs-CRP
  • 5. Change and percent change from baseline to 8 weeks of treatment for MCP-1, IL- 6, and TNF-a.
  • 6. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Ⅲ 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 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:

  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 Center Pfizer
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