A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.
Phase 4
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT00753779
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 simvastatin tablets and colesevelam HCl placebo simvastatin and Welchol placebo 1 colesevelam HCl tablets, and simvastatin tablets colesevelam HCl Tablets and simvastatin tablets
- Primary Outcome Measures
Name Time Method The percent change in LDL-C from baseline to endpoint 6 weeks
- Secondary Outcome Measures
Name Time Method The absolute and % change of total cholesterol 6 Weeks The absolute and % change in triglycerides 6 Weeks The absolute and % change in HDL-C 6 Weeks The absolute change in LDL-C from baseline to endpoint 6 weeks