CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
(+)-Epicatechindrug
Likely dose
(+)-Epicatechin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02330276
NCT02330276Phase 1Completed
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(+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

Veterans Medical Research Foundation·interventional·Posted Jan 1, 2015·Updated Apr 17, 2017

In Brief

A Phase 1 clinical trial evaluating (+)-Epicatechin for Pre-diabetes. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-diabetes
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH), San Diego Veterans Healthcare System, University of California, San Diego

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 1, 2015
Enrollment StartSep 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.5 years ago

Interventions

(+)-Epicatechindrug

The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included.