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

Hypercholesterolemia Clinical Trial

Official title:

Efficacy of WelChol® as an Add-on to Simvastatin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753779
• Other study ID #: WEL-405
• 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

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 for at least 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• 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:

• 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 Criteria:

• 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

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 simvastatin tablets
colesevelam HCl tablets, 6/day simvastatin tablet, 1/day
• simvastatin tablets and colesevelam HCl placebo
simvastatin tablet, 1/day; Welchol placebo tablets, 6/day

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 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 and % change of total cholesterol		6 Weeks	No
Secondary	The absolute and % change in triglycerides		6 Weeks	No
Secondary	The absolute and % change in HDL-C		6 Weeks	No