A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin for at Least 4 Weeks.
Phase 4
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT00754507
- Lead Sponsor
- Daiichi Sankyo
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 colesevelam HCl tablets, and atorvastatin tablets colesevelam tablets and atorvastatin tablets 2 colesevelam HCl placebo tablets and atorvastatin tablets colesevelam HCl placebo tablets and atorvastatin tablets
- Primary Outcome Measures
Name Time Method The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint. 6 weeks
- Secondary Outcome Measures
Name Time Method The absolute change in LDL-C from baseline to endpoint 6 weeks The absolute change and % change in total cholesterol 6 Weeks The absolute change and % change in triglycerides 6 Weeks The absolute change and % change in HDL-C 6 Weeks The absolute change and % change in C-reactive protein 6 weeks