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

Efficacy of WelChol as an Add-on to Pravastatin Therapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00755352

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

Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least 4 weeks.

Interventions

DRUGpravastatin tablets and Welchol tablets

pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks

DRUGpravastatin tablets and Welchol placebo tablets

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

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 = to 18 years of age * On a stable dose of pravastatin * LDL-C \> or = to 100 mg/dL and \< or = 250 mg/dL * Triglycerides \< or = to 300 mg/dL * Women are not pregnant or breast-feeding or planning to become pregnant * Women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control as specified in the protocol

Exclusion criteria

* BMI \> 40 kg/m2 * History of allergic or toxic reaction to colesevelam HCL * History of swallowing disorder * Any serious condition that would interfere with the conduct of the study

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

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