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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762164
• Other study ID #: VA---19-07-01
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2008
• Last updated: April 19, 2013
• Start date: March 2007
• Est. completion date: May 2009

Study information

• Verified date: April 2013
• Source: Bronx VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Vytorin
Vytorin 10/80 split into 4
• Simvastatin
Simvastatin 20 milligrams

Locations

Country	Name	City	State
United States	Bronx VA Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bronx VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL Cholesterol		6 weeks	No
Secondary	Total Cholesterol		6 weeks	No

External Links

•   Abstract of final results and access to corresponding manuscript