A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin 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

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-04-30

Brief Summary

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To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin 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 tablets and atorvastatin tablets

Group Type EXPERIMENTAL

colesevelam HCl tablets, and atorvastatin tablets

Intervention Type DRUG

colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks

2

colesevelam HCl placebo tablets and atorvastatin tablets

Group Type PLACEBO_COMPARATOR

colesevelam HCl placebo tablets and atorvastatin tablets

Intervention Type DRUG

colesevelam HCl placebo tablets, 6 tablets/day for 6 weeks atorvastatin tablets, 1 tablet/day for 6 weeks

Interventions

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colesevelam HCl tablets, and atorvastatin tablets

colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks

Intervention Type DRUG

colesevelam HCl placebo tablets and atorvastatin tablets

colesevelam HCl placebo tablets, 6 tablets/day for 6 weeks atorvastatin tablets, 1 tablet/day for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female \> or greater than 18 years of age
* On a stable dose of atorvastatin
* LDL-C \> or = to 115 mg/dL and \< or = to 250 mg/dL
* TG \< or = to 300 mg/dL
* Women are not pregnant or breast-feeding or planning to become pregnant
* Women of child-bearing potential had a hysterectomy or tubal-ligation, or
* women were post menopausal, or
* women practiced an acceptable method of contraception as specified in the protocol

Exclusion Criteria

* BMI \> 40 kg/m2
* History of allergic or toxic reaction to colesevelam HCl
* History of swallowing disorders
* Any serious disorder that could impact the conduct of the study
* History of drug or alcohol abuse

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No