Dyslipidemia Clinical Trial
Official title:
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects Without Diabetes Mellitus Having Very High Fasting Triglyceride Levels, With Double-Blind DCCR-Fenofibrate Combination Extension
Once a day oral administration with DCCR helps lower triglycerides
The population will consist of Statin-naive and Statin-treated subjects, all without
diabetes mellitus, with fasting triglyceride levels in the range of ≥ 500 mg/dL and < 1500
mg/dL.
Subjects will be randomly assigned to 1 of 2 treatment groups: DCCR and Placebo
Approximately 44 subjects will be enrolled in the study and stratified by Statin use at a
1:1 ratio in each treatment group,
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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