Back to resultsA Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
colesevelam HCl tablets, and simvastatin tablets
simvastatin tablets and colesevelam HCl placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
colesevelam HCl Tablets and simvastatin tablets
simvastatin and Welchol placebo
Outcomes
Primary Outcome Measures
The percent change in LDL-C from baseline to endpoint
Secondary Outcome Measures
The absolute change in LDL-C from baseline to endpoint
The absolute and % change of total cholesterol
The absolute and % change in triglycerides
The absolute and % change in HDL-C
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00753779
Brief Title
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.
Official Title
Efficacy of WelChol® as an Add-on to Simvastatin Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
April 2005 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
colesevelam HCl Tablets and simvastatin tablets
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
simvastatin and Welchol placebo
Intervention Type
Drug
Intervention Name(s)
colesevelam HCl tablets, and simvastatin tablets
Intervention Description
colesevelam HCl tablets, 6/day simvastatin tablet, 1/day
Intervention Type
Drug
Intervention Name(s)
simvastatin tablets and colesevelam HCl placebo
Intervention Description
simvastatin tablet, 1/day; Welchol placebo tablets, 6/day
Primary Outcome Measure Information:
Title
The percent change in LDL-C from baseline to endpoint
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The absolute change in LDL-C from baseline to endpoint
Time Frame
6 weeks
Title
The absolute and % change of total cholesterol
Time Frame
6 Weeks
Title
The absolute and % change in triglycerides
Time Frame
6 Weeks
Title
The absolute and % change in HDL-C
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Castle Rock
State/Province
Colorado
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
St. Petersburg
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Bartlett
State/Province
Tennessee
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.
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