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

Completed · Phase 4 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT00753779

Run by

Daiichi Sankyo

People needed

72

Starts

2002-11-01

Expected to finish

2005-04-01

Last updated by the study team

2015-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Castle Rock, Colorado, United States
• Study site — Jacksonville, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Rochester, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Bartlett, Tennessee, United States
• Study site — Norfolk, Virginia, United States
• Study site — Richmond, Virginia, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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