Phase 3
Completed N=250
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
Source: ClinicalTrials.gov NCT00782184 ↗Enrolled (actual)
250
Serious AEs
0.8%
Results posted
Oct 2011
Primary outcomePrimary: Percent Change From Baseline in Low Density Lipoprotein (LDL)-C — -26.81; -11.81 percent change from baseline — p=<0.001
Summary
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low Density Lipoprotein (LDL)-C |
-26.81; -11.81 | <0.001 sig |
| SECONDARY Number of Participants Reaching LDL-C Target Goals of <70 mg/dL |
34; 6 | <0.001 sig |
| SECONDARY Number of Participants Reaching LDL-C Target Goal <77 mg/dL |
45; 11 | <0.001 sig |
| SECONDARY Number of Participants Reaching LDL-C Target Goal <100 mg/dL |
81; 52 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol |
-15.97; -7.73 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides |
-5.41; -7.54 | 0.593 |
| SECONDARY Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol |
5.37; 2.89 | 0.211 |
| SECONDARY Percent Change From Baseline in Non-HDL Cholesterol |
-22.50; -10.88 | <0.001 sig |
| SECONDARY Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio |
-28.77; -12.66 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio |
-18.63; -8.60 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio |
-24.41; -11.20 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B |
-17.23; -9.53 | 0.002 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-1 |
2.56; -2.69 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/A-1 Ratio |
-18.59; -5.67 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) |
-6.18; -8.86 | 0.785 |
Eligibility Criteria
Inclusion Criteria
- Participants who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation
- Participant meets Adult Treatment Panel (ATP) III High Risk criteria
Exclusion Criteria
- Females who are pregnant or breastfeeding
- Participant consumes more than 14 alcoholic beverages per week
- Participant has been treated with an investigational drug within the last 30 days
- Participant has congestive heart failure (New York Heart Association [NYHA] Type III or IV)
- Participant has had gastric bypass
- Participant is newly diagnosed with type 1 or 2 diabetes
- Participant is Human Immunodeficiency Virus (HIV) positive
- Participant has a history of drug or alcohol abuse within the last 5 years
Data sourced from ClinicalTrials.gov (NCT00782184). 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.