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The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo treatment on stable background statin therapy |
|
| Gemcabene 300 mg QD | Experimental | Gemcabene (also known as CI-1027) treatment on stable background statin therapy |
|
| Gemcabene 900 mg QD | Experimental | Gemcabene (also known as CI-1027) treatment on stable background statin therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcabene | Drug | 1-300 mg tablet, QD, 56 days |
| |
| Gemcabene |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C - percent change from baseline at Week 8 | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma lipid levels - percent change from baseline at Week 8 | apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C) | 56 days |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27678439 | Derived | Stein E, Bays H, Koren M, Bakker-Arkema R, Bisgaier C. Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients. J Clin Lipidol. 2016 Sep-Oct;10(5):1212-22. doi: 10.1016/j.jacl.2016.08.002. Epub 2016 Aug 10. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C111024 | gemcabene |
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| Drug |
3-300 mg tablets, QD, 56 days |
|
| Placebo | Drug |
|
| 56 days |
| Clinical Laboratory | 56 days |
| D009750 |
| Nutritional and Metabolic Diseases |