Back to resultsEffect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Colesevelam Hydrochloride
Ezetimibe
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Safety, Efficacy, WelChol®, Zocor®, Zetia®
Eligibility Criteria
Inclusion Criteria: 18-80 years of age, inclusive; A history of primary hypercholesterolemia Exclusion Criteria: Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data; Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease
Sites / Locations
- Scripps Clinic
- Renstar Medical Research
- Radiant Research
- L-MARC Research Center
- Radiant Research
- Medical Office
- Linder Clinical Trial Center
Outcomes
Primary Outcome Measures
The percent change in LDL-C from the start of the study
Secondary Outcome Measures
- The absolute change in LDL-C from baseline
- The percent change in LDL-C from baseline
- The absolute changes and percent changes in TG, non-HDL-
C, HDL-C, total cholesterol and other lipid measures
- The percentages of patients who achieve target levels of LDL-C at the end of the study
Full Information
NCT ID
NCT00185107
First Posted
September 9, 2005
Last Updated
September 10, 2007
Sponsor
Daiichi Sankyo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00185107
Brief Title
Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Combination With Zetia® Compared to Zetia® Alone in Patients With Primary Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Safety, Efficacy, WelChol®, Zocor®, Zetia®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Colesevelam Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Primary Outcome Measure Information:
Title
The percent change in LDL-C from the start of the study
Secondary Outcome Measure Information:
Title
- The absolute change in LDL-C from baseline
Title
- The percent change in LDL-C from baseline
Title
- The absolute changes and percent changes in TG, non-HDL-
Title
C, HDL-C, total cholesterol and other lipid measures
Title
- The percentages of patients who achieve target levels of LDL-C at the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-80 years of age, inclusive;
A history of primary hypercholesterolemia
Exclusion Criteria:
Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease
Facility Information:
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Radiant Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Radiant Research
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Medical Office
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Linder Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol
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