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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00754039
First received: September 15, 2008
Last updated: September 16, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Hyperlipidemia, Familial Combined
Drug: colesevelam HCl tablets and fenofibrate tablets
Drug: fenofibrate tablets and Welchol placebo tablets
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

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

Secondary Outcome Measures:
  • The absolute change in LDL-C from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • The absolute change and % change in LDL-C from week -8 (untreated) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • The percentage of patients who achieved target LDL-C [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: February 2003
Study Completion Date: March 2004
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Welchol + TriCor
Drug: colesevelam HCl tablets and fenofibrate tablets
Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
Placebo Comparator: 2
Welchol + placebo
Drug: fenofibrate tablets and Welchol placebo tablets
fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day
Drug: fenofibrate tablets and Welchol placebo tablets
fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  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: NCT00754039

Locations
United States, Florida
Longwood, Florida, United States
Ocala, Florida, United States
Winterpark, Florida, United States
United States, Illinois
Chicago, Illinois, United States
Lombard, Illinois, United States
United States, Kansas
Overland Park, Kansas, United States
United States, North Carolina
Stateville, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Texas
San Antonio, Texas, United States
United States, Virginia
Richmond, Virginia, United States
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Senior Director, Metabolic Medical Research, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00754039     History of Changes
Other Study ID Numbers: WEL-403
Study First Received: September 15, 2008
Last Updated: September 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Mixed hyperlipidemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemia, Familial Combined
Hyperlipidemias
Dyslipidemias
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Colesevelam
Fenofibrate
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014