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

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00753779

WEL-405

Details and patient eligibility

About

The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females
• > or = to 18 years of age
• On a stable dose of simvastatin for 4 or more weeks
• LDL-C > or = to 115 mg/dL and < or = to 250 mg/dL
• TG < 300 mg/dL
• Women are not pregnant or breast-feeding or planning to become pregnant
• Women had a hysterectomy or tubal ligation or are post menopausal or are practicing an acceptable method of contraception

Exclusion criteria

• BMI > 40
• Allergic to colesevelam HCl
• History of swallowing disorder
• History of gastrointestinal motility disorder
• Any disorder that might interfere with 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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72 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

colesevelam HCl Tablets and simvastatin tablets

Treatment:

Drug: colesevelam HCl tablets, and simvastatin tablets

2

Placebo Comparator group

Description:

simvastatin and Welchol placebo

Treatment:

Drug: simvastatin tablets and colesevelam HCl placebo