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Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

NCT00754039 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2015-04-03

No results posted yet for this study

Summary

The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.

Conditions

Interventions

DRUG

colesevelam HCl tablets and fenofibrate tablets

Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day

DRUG

fenofibrate tablets and Welchol placebo tablets

fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day

DRUG

fenofibrate tablets and Welchol placebo tablets

fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2003-09-30
Completion
2004-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00754039 on ClinicalTrials.gov