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

Viatris

Status and phase: Completed; Phase 4

Conditions: Dyslipidemias

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540293

A2581157

Details and patient eligibility

About

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.

Enrollment: 425 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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425 participants in 1 patient group

Treatment group

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin