Status:
COMPLETED
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00753779
Start Date
November 1 2002
End Date
April 1 2005
Last Update
April 3 2015
Active Locations (14)
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1
Los Angeles, California, United States
2
Castle Rock, Colorado, United States
3
Jacksonville, Florida, United States
4
Pembroke Pines, Florida, United States