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Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vytorin
Simvastatin
Sponsored by
Bronx VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia, Statins, Ezetimibe

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects with an LDL-cholesterol greater than 100 mg/dL
  • Patients willing and able to provide signed informed consent

Exclusion Criteria:

  • Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
  • Patients intolerant of statins
  • Patients receiving ezetimibe
  • Patients intolerant of ezetimibe
  • Patients receiving a niacin preparation
  • 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 < 50 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 azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months
  • Active use of macrolide antibiotics or verapamil
  • Consumption of grapefruit juice on a daily basis
  • Patients unwilling or unable to provide informed consent
  • Patients with poor compliance
  • Women of childbearing potential

Sites / Locations

  • Bronx VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1Vytorin 10/80 divided into 4

Simvastatin

Arm Description

Vytorin 10/80 divided into 4

Simvastatin 20 milligrams

Outcomes

Primary Outcome Measures

LDL Cholesterol

Secondary Outcome Measures

Total Cholesterol

Full Information

First Posted
September 29, 2008
Last Updated
April 19, 2013
Sponsor
Bronx VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00762164
Brief Title
Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol
Official Title
Comparative Efficacy of a Vytorin 10/80 Tablet Split Into 4 (Estimated Dose Ezetimibe 2.5 + Simvastatin 20) Versus Simvastatin 20 Milligrams on LDL Cholesterol
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bronx VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Hypercholesterolemia, Statins, Ezetimibe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1Vytorin 10/80 divided into 4
Arm Type
Active Comparator
Arm Description
Vytorin 10/80 divided into 4
Arm Title
Simvastatin
Arm Type
Active Comparator
Arm Description
Simvastatin 20 milligrams
Intervention Type
Drug
Intervention Name(s)
Vytorin
Intervention Description
Vytorin 10/80 split into 4
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
Simvastatin 20 milligrams
Primary Outcome Measure Information:
Title
LDL Cholesterol
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Total Cholesterol
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects with an LDL-cholesterol greater than 100 mg/dL Patients willing and able to provide signed informed consent Exclusion Criteria: Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol) Patients intolerant of statins Patients receiving ezetimibe Patients intolerant of ezetimibe Patients receiving a niacin preparation 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 < 50 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 azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months Active use of macrolide antibiotics or verapamil Consumption of grapefruit juice on a daily basis Patients unwilling or unable to provide informed consent Patients with poor compliance Women of childbearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Baruch, MD
Organizational Affiliation
Bronx 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

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol

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