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

Hypercholesterolemia Clinical Trial

Official title:

Efficacy of WelChol as an Add-on to Atorvastatin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754507
• Other study ID #: WEL-406
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2008
• Last updated: April 2, 2015
• Start date: November 2002
• Est. completion date: April 2005

Study information

• Verified date: April 2015
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2005
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• colesevelam HCl tablets, and atorvastatin tablets
colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks
• colesevelam HCl placebo tablets and atorvastatin tablets
colesevelam HCl placebo tablets, 6 tablets/day for 6 weeks atorvastatin tablets, 1 tablet/day for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint.		6 weeks	No
Secondary	The absolute change in LDL-C from baseline to endpoint		6 weeks	No
Secondary	The absolute change and % change in total cholesterol		6 Weeks	No
Secondary	The absolute change and % change in triglycerides		6 Weeks	No
Secondary	The absolute change and % change in HDL-C		6 Weeks	No
Secondary	The absolute change and % change in C-reactive protein		6 weeks	No