Back to resultsStudy 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
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Mixed hyperlipidemia
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.)
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
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
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