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

Completed · Phase 4 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT00754507

Run by

Daiichi Sankyo

People needed

65

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…

• 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

You may not qualify if…

• 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

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 — 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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