Phase 3
Completed N=440
A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
Source: ClinicalTrials.gov NCT00783263 ↗Enrolled (actual)
440
Serious AEs
0.4%
Results posted
Sep 2011
Primary outcomePrimary: Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment — -21.57; -5.58 percent change — p=<0.001
Summary
A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment |
-21.57; -5.58 | <0.001 sig |
| SECONDARY Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum |
-18.57; -4.96; -24.00; -6.07 | <0.001 sig |
| SECONDARY Number of Participants Who Reached Their Target LDL-C Level |
130; 67 | <0.001 sig |
| SECONDARY Number of Participants in Each Stratum Who Reached Their Target LDL-C Level |
54; 30; 76; 37 | <0.001 sig |
| SECONDARY Number of Participants Who Reached the LDL-C Level of <70 mg/dl |
96; 38 | <0.001 sig |
| SECONDARY Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl |
31; 12; 65; 26 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels |
-13.00; -3.76; -5.96; -3.60; -0.67; 2.18 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive
- Participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for Coronary Heart Disease (CHD))
- Participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes Association(ADA) diet)
Exclusion Criteria
- Participant weighs less than 100 lbs (45 kg).
- Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications.
- If female, participant is pregnant or breastfeeding.
- Participant consumes more than 2 alcoholic beverages per day.
- Participant has been in a clinical trial within the last 30 days.
- Participant has heart problems such as CHF, unstable angina or heart attack.
- Participant has type 1 or 2 diabetes and has changed their medication in the last 2 months.
- Participant has liver disease.
- Participant is Human Immunodeficiency Virus (HIV) positive.
- Participant has a history of drug or alcohol abuse in the last year.
Data sourced from ClinicalTrials.gov (NCT00783263). 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.