Hypercholesterolemia
Conditions
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.
Interventions
DRUGcolesevelam HCl tablets, and simvastatin tablets
colesevelam HCl tablets, 6/day simvastatin tablet, 1/day
DRUGsimvastatin tablets and colesevelam HCl placebo
simvastatin tablet, 1/day; Welchol placebo tablets, 6/day
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent change in LDL-C from baseline to endpoint | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The absolute change in LDL-C from baseline to endpoint | 6 weeks |
| 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 |
Countries
United States
Outcome results
None listed