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Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy

NCT01239004 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2012-01-06

No results posted yet for this study

Summary

The present study will assess the low-density lipoprotein cholesterol (LDL-C) lowering effect of colesevelam as an adjunct to niacin for the improvement of lipids and glycemic control in dyslipidemic subjects with impaired fasting glucose.

Conditions

Interventions

DRUG

Placebo

6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks

DRUG

Colesevelam

6 tablets (3750 mg total) daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks

Sponsors & Collaborators

  • Radiant Research

    lead OTHER

Principal Investigators

  • Michael H Davidson, MD, FACC · Executive Medical Director, Radiant Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01239004 on ClinicalTrials.gov