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

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: colesevelam HCl tablets, and atorvastatin tablets; Drug: colesevelam HCl placebo tablets and atorvastatin tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754507

WEL-406

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

colesevelam tablets and atorvastatin tablets

Treatment:

Drug: colesevelam HCl tablets, and atorvastatin tablets

2

Placebo Comparator group

Description:

colesevelam HCl placebo tablets and atorvastatin tablets

Treatment:

Drug: colesevelam HCl placebo tablets and atorvastatin tablets