Phase 3
Completed N=436
Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
Source: ClinicalTrials.gov NCT00683618 ↗Enrolled (actual)
436
Serious AEs
0.5%
Results posted
Mar 2012
Primary outcomePrimary: Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg — -41.70; -38.67 percent change
Summary
This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg |
-41.70; -38.67 | — |
| PRIMARY Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg |
-46.28; -38.67 | — |
| SECONDARY Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 |
5.63; 6.82; 3.64 | — |
| SECONDARY Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 |
-29.62; -33.14; -28.06 | — |
| SECONDARY Percentage Change From Baseline in Triglycerides (TG) at Week 6 |
-20.09; -22.05; -20.67 | — |
| SECONDARY Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6 |
-38.60; -46.08; -38.50 | — |
| SECONDARY Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6 |
-36.55; -41.21; -34.67 | — |
| SECONDARY Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6 |
3.67; 4.25; 1.79 | — |
| SECONDARY Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6 |
-32.95; -38.04; -31.92 | — |
| SECONDARY Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6 |
-44.07; -50.27; -41.04 | — |
| SECONDARY Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6 |
-41.79; -56.63; -48.33 | — |
| SECONDARY Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6 |
-37.62; -41.87; -35.15 | — |
| SECONDARY Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6 |
61.0; 79.1; 58.3 | — |
| SECONDARY 6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6 |
66.9; 78.4; 60.4 | — |
| SECONDARY Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration |
41.2; 47.6 | — |
Eligibility Criteria
Inclusion Criteria
- Treated for or diagnosed hypercholesterolemia or have had a high risk with hypercholesterolemia
- LDL-C between 3.36mmol/L and 6.5 mmol/L if not treated with statin or between 2.6mmol/L and 4.14 mmol/L
- Fasting triglyceride less than 4.52mmol/L
Exclusion Criteria
- History of statin induced myopathy
- Unstable or uncontrolled cardiovascular diseases
- Familial dysbetalipoproteinemia
Data sourced from ClinicalTrials.gov (NCT00683618). 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.