Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study (AT GOAL)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00540293
First received: October 4, 2007
Last updated: August 14, 2009
Last verified: March 2009
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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:
MedlinePlus related topics:
Cholesterol
Drug Information available for:
Atorvastatin calcium
U.S. FDA Resources
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:
- 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)
Contacts and Locations
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, 614-735 | |
| Pfizer Investigational Site | |
| Busan, Korea, Republic of, 602-739 | |
| 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, 463-707 | |
| Pfizer Investigational Site | |
| Gyeonggi-do, Korea, Republic of, 431-070 | |
| 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, 110-746 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 143-914 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 136-705 | |
| 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, 134-010 | |
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 Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013