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

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

Summary

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.

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

Details

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

Criteria

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