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Diazoxide Choline Controlled-Release

Phase 2

Hypertriglyceridemia | Small molecule | Cardiovascular |Medpace Holdings, Inc. Common Stock|Last Updated: Jan 10, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

Diazoxide Choline Controlled-Release · 1 trial · 2 indications

Phase 2 1
NCT01211847Efficacy Study of Diazoxide Choline to Treat HypertriglyceridemiaHypertriglyceridemia
COMPLETED44 Analytics
PHASE2COMPLETED
Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia
HypertriglyceridemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Triglyceride-lowering efficacy of DCCR
84 days

Fasting triglycerides (percent change from Baseline to Day 84)

Secondary Endpoints

Improvement in other lipid profiles with DCCR
84 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DCCREXPERIMENTALDCCR Treatment with 290 mg Diazoxide Choline
PlaceboPLACEBO_COMPARATORPlacebo matching DCCR

Interventions

NameTypeDescription
Diazoxide Choline Controlled-Release TabletDRUGDCCR 290 mg once a day for 126 days
PlaceboDRUGPlacebo matching DCCR
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

INCLUSION CRITERIA: Fasting triglycerides * Difference between Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit) ≤ 60% (compared to the higher value of Visit 3 or Visit 4) * Run-in Triglycerides\* ≥ 500 mg/dL and \< 1500 mg/dL \*Run-in Triglyceride is defined as...

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