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

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Hyperlipidemia, Familial Combined; Hypercholesterolemia

Treatments: Drug: fenofibrate tablets and Welchol placebo tablets; Drug: colesevelam HCl tablets and fenofibrate tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754039

WEL-403

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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129 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Welchol + TriCor

Treatment:

Drug: colesevelam HCl tablets and fenofibrate tablets

2

Placebo Comparator group

Description:

Welchol + placebo

Treatment:

Drug: fenofibrate tablets and Welchol placebo tablets

Drug: fenofibrate tablets and Welchol placebo tablets