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

Efficacy of WelChol as an Add-on to Atorvastatin Therapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00754507

Enrollment

Registered

2008-09-18

Start date

2002-11-30

Completion date

2005-04-30

Last updated

2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

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.

Interventions

DRUGcolesevelam HCl tablets, and atorvastatin tablets

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

DRUGcolesevelam HCl placebo tablets and atorvastatin tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint.	6 weeks

Secondary

Measure	Time frame
The absolute change and % change in total cholesterol	6 Weeks
The absolute change and % change in triglycerides	6 Weeks
The absolute change and % change in HDL-C	6 Weeks
The absolute change and % change in C-reactive protein	6 weeks
The absolute change in LDL-C from baseline to endpoint	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026