A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin for at Least 4 Weeks.

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: colesevelam HCl tablets, and atorvastatin tablets; Drug: colesevelam HCl placebo tablets and atorvastatin tablets

• Registration Number: NCT00754507
• Lead Sponsor: Daiichi Sankyo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2003-06
• Study Completion: 2005-04
• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-16
• Study First Posted: 2008-09-18
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	colesevelam HCl tablets, and atorvastatin tablets	colesevelam tablets and atorvastatin tablets
2	colesevelam HCl placebo tablets and atorvastatin tablets	colesevelam HCl placebo tablets and atorvastatin tablets

Primary Outcome Measures

Name	Time	Method
The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint.	6 weeks

Secondary Outcome Measures

Name	Time	Method
The absolute change in LDL-C from baseline to endpoint	6 weeks
The absolute change and % change in total cholesterol	6 Weeks
The absolute change and % change in triglycerides	6 Weeks
The absolute change and % change in HDL-C	6 Weeks
The absolute change and % change in C-reactive protein	6 weeks