Status:
COMPLETED
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin for at Least 4 Weeks.
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at least 4 weeks.
Eligibility Criteria
Inclusion
- Male or female \> or greater than 18 years of age
- On a stable dose of atorvastatin
- LDL-C \> or = to 115 mg/dL and \< or = to 250 mg/dL
- TG \< or = to 300 mg/dL
- Women are not pregnant or breast-feeding or planning to become pregnant
- Women of child-bearing potential had a hysterectomy or tubal-ligation, or
- women were post menopausal, or
- women practiced an acceptable method of contraception as specified in the protocol
Exclusion
- BMI \> 40 kg/m2
- History of allergic or toxic reaction to colesevelam HCl
- History of swallowing disorders
- Any serious disorder that could impact the conduct of 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 :
65 Patients enrolled
Trial Details
Trial ID
NCT00754507
Start Date
November 1 2002
End Date
April 1 2005
Last Update
April 3 2015
Active Locations (13)
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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