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

April 2, 2015 updated by: Daiichi Sankyo, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
    • Colorado
      • Castle Rock, Colorado, United States
    • Florida
      • Jacksonville, Florida, United States
      • Pembroke Pines, Florida, United States
      • St. Petersburg, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • New York
      • Rochester, New York, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Tennessee
      • Bartlett, Tennessee, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
colesevelam HCl Tablets and simvastatin tablets
Drug: colesevelam HCl tablets, and simvastatin tablets
colesevelam HCl tablets, 6/day simvastatin tablet, 1/day
Placebo Comparator: 2
simvastatin and Welchol placebo
Drug: simvastatin tablets and colesevelam HCl placebo
simvastatin tablet, 1/day; Welchol placebo tablets, 6/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percent change in LDL-C from baseline to endpoint
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The absolute change in LDL-C from baseline to endpoint
Time Frame: 6 weeks
6 weeks
The absolute and % change of total cholesterol
Time Frame: 6 Weeks
6 Weeks
The absolute and % change in triglycerides
Time Frame: 6 Weeks
6 Weeks
The absolute and % change in HDL-C
Time Frame: 6 Weeks
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

September 16, 2008

First Submitted That Met QC Criteria

September 16, 2008

First Posted (Estimate)

September 17, 2008

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEL-405

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypercholesterolemia

Clinical Trials on colesevelam HCl tablets, and simvastatin tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe