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

NCT00762164 — Phase 4, Completed, 34 participants, Bronx VA Medical Center

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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

RegistryNCT00762164
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment34 (Actual)
SponsorBronx VA Medical Center (Fed)
ConditionsHypercholesterolemia
InterventionsVytorin, Simvastatin (Drug)
Datesstart 2007-03-01, primary completion 2009-04-01, completion 2009-05-01, first posted 2008-09-30, last updated 2013-07-03
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Hypercholesterolemia All trials of Vytorin All trials of Simvastatin

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
1Vytorin 10/80 divided into 4Active comparatorDrug: VytorinVytorin 10/80 divided into 4
SimvastatinActive comparatorDrug: SimvastatinSimvastatin 20 milligrams
  • Vytorin (Drug): Vytorin 10/80 split into 4
  • Simvastatin (Drug): Simvastatin 20 milligrams

+Outcome measures

Primary outcomes

  • LDL Cholesterol [6 weeks]

Secondary outcomes

  • Total Cholesterol [6 weeks]

+Eligibility

Sex: All, ages: 18 Years to any, accepts 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

+Posted results

Participant flow

Milestone1Vytorin 10/80 Divided Into 4Simvastatin
Started1717
Completed1415
Not completed32

Outcome results

  • LDL Cholesterol (Primary), Mean, % change in LDL cholesterol: 1Vytorin 10/80 Divided Into 4 -44.7 +/- 19.0; Simvastatin -27.1 +/- 22.4
  • Total Cholesterol (Secondary), Mean, % change in total cholesterol: 1Vytorin 10/80 Divided Into 4 -34.2 +/- 13.0; Simvastatin -19.9 +/- 14.6

Adverse events

Time frame: 6 weeks

ArmDeathsSerious adverse eventsOther adverse events
1Vytorin 10/80 Divided Into 400/17 (0.0%)2/17 (11.8%)
Simvastatin00/16 (0.0%)0/16 (0.0%)

Other adverse events by term

TermOrgan system1Vytorin 10/80 Divided Into 4Simvastatin
Muscle pain-MyalgiaMusculoskeletal and connective tissue disorders2/170/16

+Locations (1)

FacilityCityCountryStatus
Bronx VA Medical CenterThe Bronx, New YorkUnited States

+Investigators