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

The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00754039

Enrollment

129

Registered

2008-09-17

Start date

2003-02-28

Completion date

2004-03-31

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, Hyperlipidemia, Familial Combined

Keywords

Mixed hyperlipidemia

Brief 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.

Interventions

DRUGcolesevelam HCl tablets and fenofibrate tablets

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

DRUGfenofibrate tablets and Welchol placebo tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 30-70 years of age * History of mixed hyperlipidemia * Prescribed a Step 1 diet at least 30 days prior to screening * Women were not pregnant, breast-feeding, or plan to become pregnant during the study * Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures * Serum LDL-C \>/= 115 mg/dL; Serum TG \>/= 150 & \< 750 mg/dL

Exclusion criteria

* BMI \>40 * HbA1C \> 10% * Type 1 diabetes * Intolerance to fibrates * History of intolerance to colesevelam HCl * History of swallowing disorders or intestinal motility disorders * Any other disorder that might interfere with the conduct of the study * History of drug or alcohol abuse * Recent (within 28 days) history of cardiac disease (MI, CHF, CABG, etc.)

Design outcomes

Primary

Measure	Time frame
% change in LDL-C from baseline	6 weeks

Secondary

Measure	Time frame
The absolute change in LDL-C from baseline	6 weeks
The absolute change and % change in LDL-C from week -8 (untreated)	14 weeks
The percentage of patients who achieved target LDL-C	6 Weeks

Countries

United States

Outcome results

None listed

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