Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study (AT GOAL)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00540293
First received: October 4, 2007
Last updated: August 14, 2009
Last verified: March 2009

October 4, 2007
August 14, 2009
October 2007
May 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00540293 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. [ Time Frame: Baseline, and 8 weeks ] [ Designated as safety issue: No ]
  • Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dyslipidemias
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
Experimental: Treatment group
this patient group consists of dyslipidemia patients with various CVD risk factors
Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
425
May 2008
May 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00540293
A2581157
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

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