Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
Phase 4
Completed
- Conditions
- HypercholesterolemiaHyperlipidemia, Familial Combined
- Interventions
- Registration Number
- NCT00754039
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
Inclusion Criteria
- 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
Exclusion Criteria
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 fenofibrate tablets and Welchol placebo tablets Welchol + placebo 1 colesevelam HCl tablets and fenofibrate tablets Welchol + TriCor
- Primary Outcome Measures
Name Time Method % change in LDL-C from baseline 6 weeks
- Secondary Outcome Measures
Name Time Method The absolute change in LDL-C from baseline 6 weeks The absolute change and % change in LDL-C from week -8 (untreated) 14 weeks The percentage of patients who achieved target LDL-C 6 Weeks