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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000872-40 | EudraCT Number |
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This study is to determine a dose response signal for LCQ908 monotherapy and to assess the efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCQ908 1 | Experimental | LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks |
|
| LCQ908 2 | Experimental | LCQ908 once daily for 12 weeks |
|
| LCQ908 3 | Experimental | LCQ908 once daily for 12 weeks |
|
| Fenofibrate | Active Comparator | Intervention Type: Drug Intervention Name: Fenofibrate |
|
| Fish Oil | Active Comparator | Fish oil once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCQ908 | Drug |
| ||
| Fenofibrate |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in triglycerides (TG) relative to placebo at 6 weeks | The dose response signal of 3 dose regiments of LCQ908 in patients at risk for non-FCS chylomicronemia as was measured by change from baseline in triglycerides (TG) relative to placebo at 6 weeks. | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks | Baseline, 12 weeks | |
| Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Muscle Shoals | Alabama | 35662 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CLCQ908C2201 from the Novartis Clinical Trials website | View source |
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| Arm Label: Placebo | Placebo Comparator | Intervention Type: other Intervention Name: other |
|
| Drug |
Fenofibrate once daily 12 weeks |
|
| Fish Oil | Drug | Fish Oil once daily for 12 weeks |
|
|
| Placebo of LCQ908 | Drug | Matching placebo of LCQ908 |
|
| Placebo of fenofibrate | Drug | Matching placebo of fenofibrate |
|
| Placebo of fish oil | Drug | Matching placebo of fish oil capsule |
|
| Baseline, 6 weeks |
| Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks | Baseline, 12 weeks |
| Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death | 12 weeks |
| changefrom baseline in lipids and lipoprotein profiles | Baseline, 6 weeks |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Novartis Investigative Site | Encinitas | California | 92024-1332 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80906 | United States |
| Novartis Investigative Site | Brandon | Florida | 33511 | United States |
| Novartis Investigative Site | Miami | Florida | 33156 | United States |
| Novartis Investigative Site | Ocala | Florida | 34471 | United States |
| Novartis Investigative Site | Orange City | Florida | 32763 | United States |
| Novartis Investigative Site | Orlando | Florida | 32806 | United States |
| Novartis Investigative Site | Port Orange | Florida | 32127 | United States |
| Novartis Investigative Site | St. Petersburg | Florida | 33709 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40213 | United States |
| Novartis Investigative Site | Oxon Hill | Maryland | 20745 | United States |
| Novartis Investigative Site | Butte | Montana | 59701 | United States |
| Novartis Investigative Site | Cary | North Carolina | 27518 | United States |
| Novartis Investigative Site | Salisbury | North Carolina | 28144 | United States |
| Novartis Investigative Site | Lyndhurst | Ohio | 44124 | United States |
| Novartis Investigative Site | Marion | Ohio | 43302 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73103 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73135 | United States |
| Novartis Investigative Site | Tulsa | Oklahoma | 74136 | United States |
| Novartis Investigative Site | Eugene | Oregon | 97404 | United States |
| Novartis Investigative Site | Lansdale | Pennsylvania | 19446 | United States |
| Novartis Investigative Site | Bristol | Tennessee | 37620 | United States |
| Novartis Investigative Site | Boerne | Texas | 78006 | United States |
| Novartis Investigative Site | Corpus Christi | Texas | 78404 | United States |
| Novartis Investigative Site | Houston | Texas | 77074 | United States |
| Novartis Investigative Site | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Novartis Investigative Site | Ste-Foy | Quebec | G1V4M6 | Canada |
| Novartis Investigative Site | Moscow | 121552 | Russia |
| Novartis Investigative Site | Moscow | 129090 | Russia |
| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000594809 | pradigastat |
| D011345 | Fenofibrate |
| D005395 | Fish Oils |
| C405603 | Omacor |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| D009821 | Oils |
| D008055 | Lipids |
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