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OpenTrials
Completed

NCT Number: NCT00753779

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colesevelam HCl tablets, and simvastatin tablets

Drug

colesevelam HCl tablets, 6/day simvastatin tablet, 1/day

simvastatin tablets and colesevelam HCl placebo

Drug

simvastatin tablet, 1/day; Welchol placebo tablets, 6/day

Primary outcomes

  1. The percent change in LDL-C from baseline to endpoint

    Time frame: 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2005
First posted
Sep 17, 2008
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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