A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.
Efficacy of WelChol® as an Add-on to Simvastatin Therapy
1 other identifier
interventional
72
1 country
14
Brief Summary
The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2002
Typical duration for phase_4
14 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
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 16, 2008
CompletedFirst Posted
Study publicly available on registry
September 17, 2008
CompletedApril 3, 2015
April 1, 2015
7 months
September 16, 2008
April 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The percent change in LDL-C from baseline to endpoint
6 weeks
Secondary Outcomes (4)
The absolute change in LDL-C from baseline to endpoint
6 weeks
The absolute and % change of total cholesterol
6 Weeks
The absolute and % change in triglycerides
6 Weeks
The absolute and % change in HDL-C
6 Weeks
Study Arms (2)
1
EXPERIMENTALcolesevelam HCl Tablets and simvastatin tablets
2
PLACEBO COMPARATORsimvastatin and Welchol placebo
Interventions
colesevelam HCl tablets, 6/day simvastatin tablet, 1/day
simvastatin tablet, 1/day; Welchol placebo tablets, 6/day
Eligibility Criteria
You may qualify if:
- Males or females
- \> or = to 18 years of age
- On a stable dose of simvastatin for 4 or more weeks
- LDL-C \> or = to 115 mg/dL and \< or = to 250 mg/dL
- TG \< 300 mg/dL
- Women are not pregnant or breast-feeding or planning to become pregnant
- Women had a hysterectomy or tubal ligation or are post menopausal or are practicing an acceptable method of contraception
You may not qualify if:
- BMI \> 40
- Allergic to colesevelam HCl
- History of swallowing disorder
- History of gastrointestinal motility disorder
- Any disorder that might interfere with the study
- History of drug or alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (14)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Castle Rock, Colorado, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Bartlett, Tennessee, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 16, 2008
First Posted
September 17, 2008
Study Start
November 1, 2002
Primary Completion
June 1, 2003
Study Completion
April 1, 2005
Last Updated
April 3, 2015
Record last verified: 2015-04