This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lawrence Baruch, Bronx VA Medical Center
ClinicalTrials.gov Identifier:
NCT00762164
First received: September 29, 2008
Last updated: April 19, 2013
Last verified: April 2013
  Purpose
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.

Condition Intervention Phase
Hypercholesterolemia Drug: Vytorin Drug: Simvastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Lawrence Baruch, Bronx VA Medical Center:

Primary Outcome Measures:
  • LDL Cholesterol [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Total Cholesterol [ Time Frame: 6 weeks ]

Enrollment: 34
Study Start Date: March 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1Vytorin 10/80 divided into 4
Vytorin 10/80 divided into 4
Drug: Vytorin
Vytorin 10/80 split into 4
Active Comparator: Simvastatin
Simvastatin 20 milligrams
Drug: Simvastatin
Simvastatin 20 milligrams

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762164

Locations
United States, New York
Bronx VA Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
Bronx VA Medical Center
Investigators
Principal Investigator: Lawrence Baruch, MD Bronx VA Medical Center
  More Information

Responsible Party: Lawrence Baruch, Staff Physician, Bronx VA Medical Center
ClinicalTrials.gov Identifier: NCT00762164     History of Changes
Other Study ID Numbers: VA---19-07-01
Study First Received: September 29, 2008
Results First Received: April 16, 2013
Last Updated: April 19, 2013

Keywords provided by Lawrence Baruch, Bronx VA Medical Center:
Hypercholesterolemia
Statins
Ezetimibe

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 21, 2017