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

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

this patient group consists of dyslipidemia patients with various CVD risk factors

Outcomes

Primary Outcome Measures

Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.
LDL-C Responders by visit and by risk group - full analysis set (FAS)

Secondary Outcome Measures

Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.
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
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
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.
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.
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
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
Percent change from baseline in hs-CRP by risk group - FAS
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
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.
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

Full Information

First Posted
October 4, 2007
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00540293
Brief Title
Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
Acronym
AT GOAL
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
425 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
this patient group consists of dyslipidemia patients with various CVD risk factors
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
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
Primary Outcome Measure Information:
Title
Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.
Description
LDL-C Responders by visit and by risk group - full analysis set (FAS)
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.
Description
LDL-C Responders by visit and by risk group - FAS
Time Frame
Week 4
Title
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Description
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
Time Frame
Weeks 4 and 8
Title
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
Description
Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride
Time Frame
weeks 4 and 8
Title
Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
Description
LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
Time Frame
8 weeks
Title
Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
Description
LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
Time Frame
8 weeks
Title
Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Description
Median baseline, and change from baseline in hs-CRP by risk group - FAS
Time Frame
4 and 8 weeks
Title
Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Description
Percent change from baseline in hs-CRP by risk group - FAS
Time Frame
4 and 8 weeks
Title
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
Description
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
Time Frame
Baseline, and 8 weeks
Title
Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is a Korean , dyslipidemic outpatient 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 %) Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline Exclusion Criteria: Is pregnant or lactating Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis Has history of intolerance or hypersensitivity to atorvastatin or other statins Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg and/or diastolic BP ≥ 100mmHg) Has HbAlc > 10% 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Daegu
State/Province
Korea
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daejeon
ZIP/Postal Code
302-718
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Gwangju
ZIP/Postal Code
503-715
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Kyunggi-do
ZIP/Postal Code
420-717
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
134-010
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
143-914
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581157&StudyName=Lipitor%20Korean%20Atorvastatin%20Goal%20Achievement%20Across%20Risk%20Levels%20Study
Description
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Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study

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