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OpenTrials
Completed

NCT Number: NCT00755352

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

Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least 4 weeks.

Completed

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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 = to 18 years of age
  • On a stable dose of pravastatin
  • LDL-C > or = to 100 mg/dL and < or = 250 mg/dL
  • Triglycerides < or = to 300 mg/dL
  • Women are not pregnant or breast-feeding or planning to become pregnant
  • Women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control as specified in the protocol

Exclusion criteria

  • BMI > 40 kg/m2
  • History of allergic or toxic reaction to colesevelam HCL
  • History of swallowing disorder
  • Any serious condition that would interfere with the conduct of the study

Treatment and study plan

pravastatin tablets and Welchol tablets

Drug

pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks

pravastatin tablets and Welchol placebo tablets

Drug

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

Primary outcomes

  1. The primary efficacy parameter was 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 of total cholesterol from baseline to endpoint

    Time frame: 6 Weeks

  3. The absolute change and % change of triglycerides from baseline to endpoint

    Time frame: 6 Weeks

  4. The absolute change and % change of HDL-C from baseline to endpoint

    Time frame: 6 Weeks

  5. The absolute change and % change of c-reactive protein from baseline to endpoint

    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 Pravastatin 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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