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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00753779
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : April 3, 2015
Information provided by:
Daiichi Sankyo, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: colesevelam HCl tablets, and simvastatin tablets Drug: simvastatin tablets and colesevelam HCl placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of WelChol® as an Add-on to Simvastatin Therapy
Study Start Date : November 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : April 2005

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

Primary Outcome Measures :
  1. The percent change in LDL-C from baseline to endpoint [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. The absolute change in LDL-C from baseline to endpoint [ Time Frame: 6 weeks ]
  2. The absolute and % change of total cholesterol [ Time Frame: 6 Weeks ]
  3. The absolute and % change in triglycerides [ Time Frame: 6 Weeks ]
  4. The absolute and % change in HDL-C [ Time Frame: 6 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00753779

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

Responsible Party: Senior Director Metobolic Research, Daiichi Sankyo, Inc. Identifier: NCT00753779     History of Changes
Other Study ID Numbers: WEL-405
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors