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Delayed recruitment, funding exhausted
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.
Correct
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose Statin | Experimental | 80 mg atorvastatin daily for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lipitor | Drug | 80 mg everyday (QD) for 3 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Low Density Lipoprotein (LDL) | Serum LDL, mg/dL (baseline LDL-follow-up LDL) | Change from baseline to follow-up, up to 5 weeks |
| Change in Endothelial Function as Measured on MRI in the Arms | chance from baseline to end of study, up to 5 weeks | |
| Change in Endothelial Function as Measured on MRI in the Legs | chance from baseline to end of study, up to 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Silber, MD | JHU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harry SIlber, MD | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Dose Statin | 80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Dose Statin | 80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Low Density Lipoprotein (LDL) | Serum LDL, mg/dL (baseline LDL-follow-up LDL) | 3 participants were lost to follow-up, 3 participants did not have LDL values collected/reported at follow-up | Posted | Mean | Standard Deviation | mg/dL | Change from baseline to follow-up, up to 5 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-Dose Statin | 80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harry Silber, M.D., Ph.D. Assistant Professor of Medicine, Division of Cardiology | Johns Hopkins University School of Medicine | 4105505717 | hsilber@jhmi.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Change in Endothelial Function as Measured on MRI in the Arms | No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities. | Posted | chance from baseline to end of study, up to 5 weeks |
|
|
| Primary | Change in Endothelial Function as Measured on MRI in the Legs | No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities. | Posted | chance from baseline to end of study, up to 5 weeks |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |