Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

Completed · Phase 4 · Has a placebo group

Conditions studied: Hypercholesterolemia, Hyperlipidemia, Familial Combined

In brief

The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.

Key facts

Study ID

NCT00754039

Run by

Daiichi Sankyo

People needed

129

Starts

2003-02-01

Expected to finish

2004-03-01

Last updated by the study team

2015-04-03

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 30-70 years of age
• History of mixed hyperlipidemia
• Prescribed a Step 1 diet at least 30 days prior to screening
• Women were not pregnant, breast-feeding, or plan to become pregnant during the study
• Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures
• Serum LDL-C >/= 115 mg/dL; Serum TG >/= 150 \& < 750 mg/dL

You may not qualify if…

• BMI >40
• HbA1C > 10%
• Type 1 diabetes
• Intolerance to fibrates
• History of intolerance to colesevelam HCl
• History of swallowing disorders or intestinal motility disorders
• Any other disorder that might interfere with the conduct of the study
• History of drug or alcohol abuse
• Recent (within 28 days) history of cardiac disease (MI, CHF, CABG, etc.)

Where it is running

• Study site — Longwood, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Winterpark, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Lombard, Illinois, United States
• Study site — Overland Park, Kansas, United States
• Study site — Stateville, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — San Antonio, Texas, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.