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This trial is a phase III study to evaluate the efficacy , tolerability, and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bempedoic acid | Experimental | Once daily |
|
| Placebo | Placebo Comparator | Once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bempedoic Acid Tablet | Drug | Once daily, oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in LDL-C levels at Week 12 | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in total cholesterol (TC) levels at Week 12 | Baseline, Week 12 | |
| Adverse events (AEs) and serious adverse events (SAEs) during the study | Baseline, Week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhao | Contact | 010-56456726 | wei.zhao@ganlee.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Recruiting | Beijing | China |
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| 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 |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
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| Drug |
Once daily, oral |
|