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

This study has been completed.
Information provided by:
Daiichi Sankyo Inc. Identifier:
First received: September 16, 2008
Last updated: April 2, 2015
Last verified: April 2015
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.

Condition Intervention Phase
Drug: colesevelam HCl tablets, and atorvastatin tablets
Drug: colesevelam HCl placebo tablets and atorvastatin tablets
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of WelChol as an Add-on to Atorvastatin Therapy

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • The absolute change in LDL-C from baseline to endpoint [ Time Frame: 6 weeks ]
  • The absolute change and % change in total cholesterol [ Time Frame: 6 Weeks ]
  • The absolute change and % change in triglycerides [ Time Frame: 6 Weeks ]
  • The absolute change and % change in HDL-C [ Time Frame: 6 Weeks ]
  • The absolute change and % change in C-reactive protein [ Time Frame: 6 weeks ]

Enrollment: 65
Study Start Date: November 2002
Study Completion Date: April 2005
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
colesevelam tablets and atorvastatin tablets
Drug: colesevelam HCl tablets, and atorvastatin tablets
colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks
Placebo Comparator: 2
colesevelam HCl placebo tablets and atorvastatin tablets
Drug: 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


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00754507

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, 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.
  More Information

Responsible Party: Senior Director of Metabolic Research, Daiichi Sankyo, Inc. Identifier: NCT00754507     History of Changes
Other Study ID Numbers: WEL-406
Study First Received: September 16, 2008
Last Updated: April 2, 2015

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017