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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.

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ClinicalTrials.gov Identifier: NCT00754507
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : April 3, 2015
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of WelChol as an Add-on to Atorvastatin Therapy
Study Start Date : November 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : April 2005


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The primary efficacy parameter is 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 change and % change in total cholesterol [ Time Frame: 6 Weeks ]
  3. The absolute change and % change in triglycerides [ Time Frame: 6 Weeks ]
  4. The absolute change and % change in HDL-C [ Time Frame: 6 Weeks ]
  5. The absolute change and % change in C-reactive protein [ Time Frame: 6 weeks ]


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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00754507


Locations
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.

Responsible Party: Senior Director of Metabolic Research, Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00754507     History of Changes
Other Study ID Numbers: WEL-406
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

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