Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly | Week 52 | |
| LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels | Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study | Baseline and Weeks 17, 34, and 52 |
| Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study | Week 52 |
| Adverse events and laboratory test changes | Weeks 17, 34, and 52 |
| Achievement of LDL-C target | Weeks 17 and 34 |
| Achievement of LDL-C target by diabetic patients | Week 52 |
| Brasschaat |
| 2930 |
| Belgium |
| Pfizer Investigational Site | Brussels | 1180 | 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 | 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided