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

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

Summary

Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin 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; Pravastatin

Criteria

Inclusion Criteria:

• Male or female > or = to 18 years of age

• On a stable dose of pravastatin

• LDL-C > or = to 100 mg/dL and < or = 250 mg/dL

• Triglycerides < or = to 300 mg/dL

• Women are not pregnant or breast-feeding or planning to become pregnant

• Women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control as specified in the protocol

Exclusion Criteria:

• BMI > 40 kg/m2

• History of allergic or toxic reaction to colesevelam HCL

• History of swallowing disorder

• Any serious condition that would interfere with the conduct of the study