Status:
COMPLETED
Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypercholesterolemia
Hyperlipidemia, Familial Combined
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
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 cholest...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00754039
Start Date
February 1 2003
End Date
March 1 2004
Last Update
April 3 2015
Active Locations (10)
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1
Longwood, Florida, United States
2
Ocala, Florida, United States
3
Winterpark, Florida, United States
4
Chicago, Illinois, United States