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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease.
Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential therapeutic agent for hypertriglyceridemia.
Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has been formulated as a controlled-release tablet suitable for once per day dosing. This current study is designed to assess the effect of diazoxide choline on triglycerides in subjects with baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose and insulin, body weight as well as the safety and tolerability of diazoxide choline will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Diazoxide equivalent dose |
|
| 2 | Experimental | Diazoxide equivalent dose |
|
| 3 | Experimental | Diazoxide equivalent dose |
|
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazoxide choline | Drug |
| ||
| Diazoxide choline |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect on triglycerides of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect on other lipid parameters (LDL, HDL, VLDL, and non-HDL cholesterol), insulin, glucose and weight of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects | 8 weeks | |
| To assess the safety and tolerability of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold Bays, MD | L-MARC Research Center | Principal Investigator |
| Alan Forker, MD | St. Luke's Lipid and Diabetes Research Center | Principal Investigator |
| Cynthia Huffman, MD | Meridien Research | Principal Investigator |
| Michael Koren, MD | Jacksonville Center For Clinical Research | Principal Investigator |
| Andrew Lewin, MD | National Research Institute | Principal Investigator |
| Thomas Littlejohn, MD | Piedmont Medical Research Associates | Principal Investigator |
| David Morin, MD | TriCities Medical Research | Principal Investigator |
| Eli Roth, MD | Sterling Research Group, Ltd | Principal Investigator |
| Evan Stein, MD | Metabolic and Atherosclerosis Research Center (MARC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Institute | Los Angeles | California | 90057 | United States | ||
| Jacksonville Center for Clinical Research |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| Diazoxide choline | Drug |
|
| Placebo | Drug |
|
| 8 weeks |
| Philip Toth, MD |
| Midwest Institute for Clinical Research |
| Principal Investigator |
| Craig Thompson, MD | Frederick C. Smith Clinic | Principal Investigator |
| Glibert Weiner, MD | Allied Research International/Cetero Research | Principal Investigator |
| Jacksonville |
| Florida |
| 32216 |
| United States |
| Allied Research International/Cetero Research | Miami Gardens | Florida | 33169 | United States |
| Meridien Research | Tampa | Florida | 33606 | United States |
| Midwest Institute for Clinical Research | Indianapolis | Indiana | 46260 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| St. Luke's Lipid and Diabetes Research Center | Kansas City | Missouri | 64111 | United States |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | United States |
| Metabolic and Atherosclerosis Research Center (MARC) | Cincinnati | Ohio | 45212 | United States |
| Sterling Research Group, Ltd | Cincinnati | Ohio | 45219 | United States |
| Frederick C. Smith Clinic | Marion | Ohio | 43302 | United States |
| TriCities Medical Research | Bristol | Tennessee | 37620 | United States |
| D009750 |
| Nutritional and Metabolic Diseases |