Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia
1 other identifier
interventional
129
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2003
Shorter than P25 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 15, 2008
CompletedFirst Posted
Study publicly available on registry
September 17, 2008
CompletedApril 3, 2015
April 1, 2015
7 months
September 15, 2008
April 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% change in LDL-C from baseline
6 weeks
Secondary Outcomes (3)
The absolute change in LDL-C from baseline
6 weeks
The absolute change and % change in LDL-C from week -8 (untreated)
14 weeks
The percentage of patients who achieved target LDL-C
6 Weeks
Study Arms (2)
1
EXPERIMENTALWelchol + TriCor
2
PLACEBO COMPARATORWelchol + placebo
Interventions
Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (10)
Unknown Facility
Longwood, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Winterpark, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Lombard, Illinois, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Stateville, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Richmond, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 15, 2008
First Posted
September 17, 2008
Study Start
February 1, 2003
Primary Completion
September 1, 2003
Study Completion
March 1, 2004
Last Updated
April 3, 2015
Record last verified: 2015-04