Phase 4
Completed N=34
Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol
Source: ClinicalTrials.gov NCT00762164 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: LDL Cholesterol — -44.7; -27.1 % change in LDL cholesterol
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LDL Cholesterol |
-44.7; -27.1 | — |
| SECONDARY Total Cholesterol |
-34.2; -19.9 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00762164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.