Back to resultsTolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia
Primary Purpose
Hypercholesterolemia
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rosuvastatin
Ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Patients with a history of intolerance to statins
- Patients currently receiving ezetimibe
- Patients willing and able to provide signed informed consent
Exclusion Criteria:
- Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
- Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
- Cancer undergoing active treatment
- Creatinine clearance < 40 ml/minute
- Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level
- Participation in any clinical study within the last 30 days
- Drug addition or alcohol abuse within the past 6 months
- Use of cyclosporine within the last 3 months
- Use of gemfibrozil within the last month
- Patients unwilling or unable to provide informed consent
- Patients with poor compliance
- Women of childbearing potential
- History of rhabdomyolysis due to statins
Sites / Locations
- Bronx VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Crestor
Ezetimibe
Arm Description
Crestor 10 or 20 milligrams
Ezetimibe 5 or 10 milligrams
Outcomes
Primary Outcome Measures
Low-density lipoprotein (LDL) cholesterol
Low-density lipoprotein (LDL) cholesterol
Secondary Outcome Measures
The ability to remain on Crestor for the study period
Full Information
NCT ID
NCT00972829
First Posted
September 8, 2009
Last Updated
September 9, 2009
Sponsor
Bronx VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00972829
Brief Title
Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bronx VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Recently, research studies have shown that patients who have had trouble taking statins every day, are able to take statins if they take them only once or twice a week. The investigators are doing a research study which involves switching people who are taking ezetimibe to the statin Crestor once or twice a week and to see how ell Crestor lowers cholesterol and if it is tolerated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Crestor
Arm Type
Experimental
Arm Description
Crestor 10 or 20 milligrams
Arm Title
Ezetimibe
Arm Type
Active Comparator
Arm Description
Ezetimibe 5 or 10 milligrams
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
Rosuvastatin 10 or 20 milligrams once or twice a week
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
Zetia
Intervention Description
Ezetimibe 5 or 10 milligrams
Primary Outcome Measure Information:
Title
Low-density lipoprotein (LDL) cholesterol
Time Frame
6 weeks
Title
Low-density lipoprotein (LDL) cholesterol
Time Frame
3-4 months
Secondary Outcome Measure Information:
Title
The ability to remain on Crestor for the study period
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a history of intolerance to statins
Patients currently receiving ezetimibe
Patients willing and able to provide signed informed consent
Exclusion Criteria:
Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
Cancer undergoing active treatment
Creatinine clearance < 40 ml/minute
Active liver disease or persistent elevation of SGOT or SGPT > 2 times the upper limit of normal level
Participation in any clinical study within the last 30 days
Drug addition or alcohol abuse within the past 6 months
Use of cyclosporine within the last 3 months
Use of gemfibrozil within the last month
Patients unwilling or unable to provide informed consent
Patients with poor compliance
Women of childbearing potential
History of rhabdomyolysis due to statins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Baruch, MD
Organizational Affiliation
James J.Peters VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronx VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence Baruch, MD
Phone
718-584-9000
Ext
5970
Email
lawrence.baruch@va.gov
First Name & Middle Initial & Last Name & Degree
Lawrence Baruch, MD
12. IPD Sharing Statement
Learn more about this trial
Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia
We'll reach out to this number within 24 hrs