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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00753779
First received: September 16, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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 Intervention Phase
Hypercholesterolemia
Drug: colesevelam HCl tablets, and simvastatin tablets
Drug: simvastatin tablets and colesevelam HCl placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of WelChol® as an Add-on to Simvastatin Therapy

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • The percent change in LDL-C from baseline to endpoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The absolute change in LDL-C from baseline to endpoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • The absolute and % change of total cholesterol [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • The absolute and % change in triglycerides [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • The absolute and % change in HDL-C [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment: 72
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 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753779

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, 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.
  More Information

No publications provided

Responsible Party: Senior Director Metobolic Research, Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00753779     History of Changes
Other Study ID Numbers: WEL-405
Study First Received: September 16, 2008
Last Updated: September 16, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Colesevelam
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014