Phase 4
Completed N=425
Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
Dyslipidemias
Source: ClinicalTrials.gov NCT00540293 ↗
Enrolled (actual)
425
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. — 86.0; 92.9; 95.5; 84.3 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. |
86.0; 92.9; 95.5; 84.3 | — |
| SECONDARY Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment. |
81.9; 85.7; 95.5; 79.9 | — |
| SECONDARY Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment |
151.7; 187.0; 160.6; 147.7; -63.5; -73.8 | — |
| SECONDARY 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 |
-40.9; -39.5; -39.6; -41.2; -42.0; -41.2 | — |
| SECONDARY Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. |
339; 24; 41; 274; 56; 3 | — |
| SECONDARY Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. |
89.1; 95.8; 97.6; 87.2; 82.1; 100.0 | — |
| SECONDARY Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment |
0.108; 0.082; 0.075; 0.122; -0.008; -0.008 | — |
| SECONDARY Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment |
-12.346; -13.941; -2.553; -16.197; -18.605; -18.621 | — |
| SECONDARY Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. |
302.7; 305.2; 317.7; 301.6; 39.8; -15.0 | — |
| SECONDARY Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. |
14.0; -5.6; -8.0; 18.2; 0.00; 0.00 | — |
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 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)
Data sourced from ClinicalTrials.gov (NCT00540293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.