A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-04-30

Brief Summary

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The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

colesevelam HCl Tablets and simvastatin tablets

Group Type EXPERIMENTAL

colesevelam HCl tablets, and simvastatin tablets

Intervention Type DRUG

colesevelam HCl tablets, 6/day simvastatin tablet, 1/day

2

simvastatin and Welchol placebo

Group Type PLACEBO_COMPARATOR

simvastatin tablets and colesevelam HCl placebo

Intervention Type DRUG

simvastatin tablet, 1/day; Welchol placebo tablets, 6/day

Interventions

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colesevelam HCl tablets, and simvastatin tablets

colesevelam HCl tablets, 6/day simvastatin tablet, 1/day

Intervention Type DRUG

simvastatin tablets and colesevelam HCl placebo

simvastatin tablet, 1/day; Welchol placebo tablets, 6/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females
* \> or = to 18 years of age
* On a stable dose of simvastatin for 4 or more weeks
* LDL-C \> or = to 115 mg/dL and \< or = to 250 mg/dL
* TG \< 300 mg/dL
* Women are not pregnant or breast-feeding or planning to become pregnant
* Women had a hysterectomy or tubal ligation or are post menopausal or are practicing an acceptable method of contraception

Exclusion Criteria

* BMI \> 40
* Allergic to colesevelam HCl
* History of swallowing disorder
* History of gastrointestinal motility disorder
* Any disorder that might interfere with the study
* History of drug or alcohol abuse

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No