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The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step titration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previous Treatment with a Usual Maintenance Dose of a Statin | Experimental |
| |
| Statin-Naive | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | In previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change from baseline in LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, triglycerides, and apolipoprotein B for statin-naive patients | Weeks 6 and 12 | |
| Proportion of subjects across different LDL-C strata who achieved LDL-C target |
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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 | Antwerp | 2018 | Belgium | |||
| 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 | In statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled. |
|
| Week 6 |
| Proportion of diabetic subjects in entire group who achieved LDL-C target | Week 12 |
| Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL) | Week 12 |
| Change from baseline in hemoglobin A1c levels | Week 12 |
| Adverse events and laboratory test changes | Weeks 6 and 12 |
| Proportion of subjects in entire group who achieved LDL-C target | Week 6 |
| Brasschaat |
| 2930 |
| Belgium |
| Pfizer Investigational Site | Brussels | 1180 | Belgium |
| Pfizer Investigational Site | Edegem | 2650 | Belgium |
| Pfizer Investigational Site | Genk | B-3600 | Belgium |
| Pfizer Investigational Site | Ghent | 9000 | Belgium |
| Pfizer Investigational Site | Gilly (charleroi) | 6060 | Belgium |
| Pfizer Investigational Site | La Louvière | 7100 | Belgium |
| Pfizer Investigational Site | Liège | 4000 | Belgium |
| Pfizer Investigational Site | Mechelen | 2800 | Belgium |
| Pfizer Investigational Site | Menen | 8930 | Belgium |
| Pfizer Investigational Site | Merksem | 2170 | Belgium |
| Pfizer Investigational Site | Mortsel | 2640 | Belgium |
| Pfizer Investigational Site | Roeselare | 8800 | Belgium |
| Pfizer Investigational Site | Seraing | 4100 | Belgium |
| Pfizer Investigational Site | Wilrijk | 2610 | Belgium |
| Pfizer Investigational Site | Wingene | 8750 | Belgium |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| 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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