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OpenTrials
Completed

NCT Number: NCT00754039

Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.

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Key information

Conditions

Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemia, Familial Combined Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Longwood, Florida, 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

  • 30-70 years of age
  • History of mixed hyperlipidemia
  • Prescribed a Step 1 diet at least 30 days prior to screening
  • Women were not pregnant, breast-feeding, or plan to become pregnant during the study
  • Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures
  • Serum LDL-C >/= 115 mg/dL; Serum TG >/= 150 & < 750 mg/dL

Exclusion criteria

  • BMI >40
  • HbA1C > 10%
  • Type 1 diabetes
  • Intolerance to fibrates
  • History of intolerance to colesevelam HCl
  • History of swallowing disorders or intestinal motility disorders
  • Any other disorder that might interfere with the conduct of the study
  • History of drug or alcohol abuse
  • Recent (within 28 days) history of cardiac disease (MI, CHF, CABG, etc.)

Treatment and study plan

colesevelam HCl tablets and fenofibrate tablets

Drug

Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day

fenofibrate tablets and Welchol placebo tablets

Drug

fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day

Primary outcomes

  1. % change in LDL-C from baseline

    Time frame: 6 weeks

Secondary outcomes

  1. The absolute change in LDL-C from baseline

    Time frame: 6 weeks

  2. The absolute change and % change in LDL-C from week -8 (untreated)

    Time frame: 14 weeks

  3. The percentage of patients who achieved target LDL-C

    Time frame: 6 Weeks

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia

Important dates

Study start
2003
Primary completion
2003
Study completion
2004
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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