search
Back to results

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

Primary Purpose

Hypercholesterolemia, Hyperlipidemia, Familial Combined

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
colesevelam HCl tablets and fenofibrate tablets
fenofibrate tablets and Welchol placebo tablets
fenofibrate tablets and Welchol placebo tablets
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Mixed hyperlipidemia

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Welchol + TriCor

Welchol + placebo

Outcomes

Primary Outcome Measures

% change in LDL-C from baseline

Secondary Outcome Measures

The absolute change in LDL-C from baseline
The absolute change and % change in LDL-C from week -8 (untreated)
The percentage of patients who achieved target LDL-C

Full Information

First Posted
September 15, 2008
Last Updated
April 2, 2015
Sponsor
Daiichi Sankyo, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00754039
Brief Title
Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
Official Title
The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Hyperlipidemia, Familial Combined
Keywords
Mixed hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Welchol + TriCor
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Welchol + placebo
Intervention Type
Drug
Intervention Name(s)
colesevelam HCl tablets and fenofibrate tablets
Intervention Description
Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
Intervention Type
Drug
Intervention Name(s)
fenofibrate tablets and Welchol placebo tablets
Intervention Description
fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day
Intervention Type
Drug
Intervention Name(s)
fenofibrate tablets and Welchol placebo tablets
Intervention Description
fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day
Primary Outcome Measure Information:
Title
% change in LDL-C from baseline
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The absolute change in LDL-C from baseline
Time Frame
6 weeks
Title
The absolute change and % change in LDL-C from week -8 (untreated)
Time Frame
14 weeks
Title
The percentage of patients who achieved target LDL-C
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Facility Information:
City
Longwood
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Winterpark
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Lombard
State/Province
Illinois
Country
United States
City
Overland Park
State/Province
Kansas
Country
United States
City
Stateville
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs