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The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
| |
| Arm C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atorvastatin | Drug | Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in LDL-C levels from baseline to Week 12 | Week 12 | |
| Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12 | Weeks 4, 8, and 12 | |
| Adverse events at Weeks 4, 8, and 12 | Baseline and at Weeks 4, 8, and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Kaohsiung City | Taiwan | ||||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| atorvastatin | Drug | Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks |
|
| atorvastatin | Drug | Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks |
|
| Clinical laboratory changes at Weeks 4, 8, and 12 | Screening and at Weeks 4, 8, and 12 |
| Vital signs at Weeks 4, 8, and 12 | Screening and at Weeks 4, 8, and 12 |
| Percentage change in LDL-C levels from baseline at Weeks 4 and 8 | Weeks 4 and 8 |
| Percentage of LDL-C responders at Weeks 4 and 8 | Weeks 4 and 8 |
| Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12 | Weeks 4, 8, and 12 |
| Kaohsiung Hsien |
| Taiwan |
| Pfizer Investigational Site | Taichung | Taiwan |
| Pfizer Investigational Site | Taipei | Taiwan |
| Pfizer Investigational Site | Taoyuan Hsien | Taiwan |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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