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OpenTrials
Completed

NCT Number: NCT00754507

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

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.

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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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

colesevelam HCl tablets, and atorvastatin tablets

Drug

colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks

colesevelam HCl placebo tablets and atorvastatin tablets

Drug

colesevelam HCl placebo tablets, 6 tablets/day for 6 weeks atorvastatin tablets, 1 tablet/day for 6 weeks

Primary outcomes

  1. The primary efficacy parameter is 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 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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

Efficacy of WelChol as an Add-on to Atorvastatin Therapy

Important dates

Study start
2002
Primary completion
2003
Study completion
2005
First posted
Sep 18, 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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