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

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ClinicalTrials.gov Identifier: NCT00754039
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : April 3, 2015
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolemia Hyperlipidemia, Familial Combined Drug: colesevelam HCl tablets and fenofibrate tablets Drug: fenofibrate tablets and Welchol placebo tablets Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia
Study Start Date : February 2003
Actual Primary Completion Date : September 2003
Actual Study Completion Date : March 2004


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. % change in LDL-C from baseline [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Senior Director, Metabolic Medical Research, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00754039     History of Changes
Other Study ID Numbers: WEL-403
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Daiichi Sankyo, Inc.:
Mixed hyperlipidemia

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