CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Placebo Comparator: First Intervention (3 weeks) +3 moredrug
Likely dose
Active Comparator: Second Intervention (3 weeks) 80mgfrom 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/NCT00455325
NCT00455325Phase 2Completed
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Genotoxic Stress, Atherosclerosis, and Metabolic Syndrome-AIM 2

Washington University School of Medicine·interventional·Posted Apr 3, 2007·Updated May 10, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo Comparator: First Intervention (3 weeks), Active Comparator: Second Intervention (3 weeks), and 2 other interventions for Metabolic Syndrome X and 4 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Metabolic syndrome consists of a group of co-occuring conditions that increase an individual's risk of developing heart disease, stroke, and diabetes. The purpose of this study is to evaluate the short-term effectiveness of chloroquine, a protein-activation medication, at improving metabolic syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Syndrome X, Overweight, Hypertension, Dyslipidemias, Prediabetic State
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 3, 2007
Enrollment StartSep 1, 2004
Primary CompletionJun 1, 2010
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 19.2 years ago

Interventions

Placebo Comparator: First Intervention (3 weeks)drug

once daily placebo tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells

Active Comparator: Second Intervention (3 weeks)drug

Once daily 80mg chloroquine or placebo tablet 3 Weeks followed by euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells

Active Comparator: Third Intervention (3 weeks)drug

Once daily 80mg tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells

Active Comparator: Fourth Intervention (3 weeks)drug

Once daily 250mg tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells