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

April 2, 2015 updated by: Daiichi Sankyo, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Longwood, Florida, United States
      • Ocala, Florida, United States
      • Winterpark, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
      • Lombard, Illinois, United States
    • Kansas
      • Overland Park, Kansas, United States
    • North Carolina
      • Stateville, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Texas
      • San Antonio, Texas, United States
    • Virginia
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% change in LDL-C from baseline
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The absolute change in LDL-C from baseline
Time Frame: 6 weeks
6 weeks
The absolute change and % change in LDL-C from week -8 (untreated)
Time Frame: 14 weeks
14 weeks
The percentage of patients who achieved target LDL-C
Time Frame: 6 Weeks
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

September 15, 2008

First Submitted That Met QC Criteria

September 16, 2008

First Posted (Estimate)

September 17, 2008

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEL-403

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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