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

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: pravastatin tablets and Welchol placebo tablets; Drug: pravastatin tablets and Welchol tablets

• Registration Number: NCT00755352
• Lead Sponsor: Daiichi Sankyo

Brief Summary

Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin 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: 67

Inclusion Criteria

• Male or female > or = to 18 years of age
• On a stable dose of pravastatin
• LDL-C > or = to 100 mg/dL and < or = 250 mg/dL
• Triglycerides < or = to 300 mg/dL
• Women are not pregnant or breast-feeding or planning to become pregnant
• Women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control as specified in the protocol

Exclusion Criteria

• BMI > 40 kg/m2
• History of allergic or toxic reaction to colesevelam HCL
• History of swallowing disorder
• Any serious condition that would interfere with the conduct of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	pravastatin tablets and Welchol placebo tablets	pravastatin tablets and Welchol placebo tablets
1	pravastatin tablets and Welchol tablets	pravastatin tablets and Welchol tablets

Primary Outcome Measures

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

Secondary Outcome Measures

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