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This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETC-1002 | Experimental | ETC-1002 treatment group, oral once daily |
|
| Placebo | Placebo Comparator | Placebo treatment group, oral once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETC-1002 | Drug | Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites | 4 and 8 weeks | |
| Peak plasma concentration (Cmax) of atorvastatin and its active metabolites | 4 and 8 weeks | |
| Number of subjects with adverse events, clinical lab abnormalities and other safety findings | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in LDL-C | 2, 4, 6 and 8 weeks | |
| Percent change in other lipids and cardio-metabolic risk factors | 2, 4, 6 and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of ETC-1002 and its active metabolite | 4 and 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noah Rosenberg, MD | Esperion Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indianapolis | Indiana | 46260 | United States | |||
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| Placebo | Drug | Placebo once daily for 8 weeks |
|
| Atorvastatin | Drug | Atorvastatin 10mg once daily for 8 weeks |
|
| Louisville |
| Kentucky |
| 40213 |
| United States |
| Richmond | Virginia | 23294 | United States |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
| 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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