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
  Purpose

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.


Condition Intervention Phase
Dyslipidemias
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 425
Study Start Date: October 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
this patient group consists of dyslipidemia patients with various CVD risk factors
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540293

Locations
Korea, Republic of
Pfizer Investigational Site
Daegu, Korea, Korea, Republic of, 705-717
Pfizer Investigational Site
Seoul, Korea, Korea, Republic of, 135-710
Pfizer Investigational Site
Busan, Korea, Republic of, 602-739
Pfizer Investigational Site
Busan, Korea, Republic of, 614-735
Pfizer Investigational Site
Daegu, Korea, Republic of, 700-712
Pfizer Investigational Site
Daejeon, Korea, Republic of, 302-718
Pfizer Investigational Site
Gwangju, Korea, Republic of, 503-715
Pfizer Investigational Site
Gwangju, Korea, Republic of, 501-757
Pfizer Investigational Site
Gyeonggi-do, Korea, Republic of, 431-070
Pfizer Investigational Site
Gyeonggi-do, Korea, Republic of, 463-707
Pfizer Investigational Site
Incheon, Korea, Republic of, 405-760
Pfizer Investigational Site
Kyunggi-do, Korea, Republic of, 420-717
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 143-914
Pfizer Investigational Site
Seoul, Korea, Republic of, 136-705
Pfizer Investigational Site
Seoul, Korea, Republic of, 134-010
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 137-701
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-746
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00540293     History of Changes
Other Study ID Numbers: A2581157
Study First Received: October 4, 2007
Results First Received: May 8, 2009
Last Updated: August 14, 2009
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014