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The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcabene 150 mg | Experimental | Gemcabene 150 mg once daily (QD) |
|
| Gemcabene 300 mg | Experimental | Gemcabene 300 mg once daily (QD) |
|
| Gemcabene 600 mg | Experimental | Gemcabene 600 mg once daily (QD) |
|
| Gemcabene 900 mg | Experimental | Gemcabene 900 mg once daily (QD) |
|
| Placebo | Placebo Comparator | Placebo once daily (QD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcabene 150 mg | Drug | Blinded capsules and tablets, 150 mg, once daily, 84 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HDL-C - percent change from baseline | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline | 84 days | |
| Adverse Events | 84 days | |
| Clinical Laboratory - hematology, chemistry, urinalysis |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12943873 | Background | Bays HE, McKenney JM, Dujovne CA, Schrott HG, Zema MJ, Nyberg J, MacDougall DE; Gemcabene Study Group. Effectiveness and tolerability of a new lipid-altering agent, gemcabene, in patients with low levels of high-density lipoprotein cholesterol. Am J Cardiol. 2003 Sep 1;92(5):538-43. doi: 10.1016/s0002-9149(03)00721-5. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D015228 | Hypertriglyceridemia |
| 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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| Gemcabene 300 mg |
| Drug |
Blinded capsules and tablets, 300 mg, once daily, 84 days |
|
| Gemcabene 600 mg | Drug | Blinded capsules and tablets, 600 mg, once daily, 84 days |
|
| Gemcabene 900 mg | Drug | Blinded capsules and tablets, 900 mg, once daily, 84 days |
|
| Placebo | Drug | Blinded capsule and tablets, once daily, 84 days |
|
Clinical Laboratory Abnormalities |
| 84 days |
| D009750 |
| Nutritional and Metabolic Diseases |