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

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Colesevelam Hydrochloride; Simvastatin

Criteria

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