Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
- Registration Number
- NCT00683618
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 934
- 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
- History of statin induced myopathy
- Unstable or uncontrolled cardiovascular diseases
- Familial dysbetalipoproteinemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Rosuvastatin Rosuvastatin 5mg qd 2 Rosuvastatin Rosuvastatin 10mg qd 3 Atorvastatin Atorvastatin 10mg qd
- Primary Outcome Measures
Name Time Method Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.
- Secondary Outcome Measures
Name Time Method Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Percentage Change From Baseline in Triglycerides (TG) at Week 6 baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6 baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6 baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6 baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6 baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6 baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6 baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6 baseline, 6 weeks Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6 week 6 The percentage of patients achieved LDL-C goal is done in ITT population.
National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:
Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL), non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL), non-HDL-C goal \< 3.36mmol/L (130mg/dL)6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6 week 6 The percentage of patients achieved LDL-C goal is done in ITT population.
National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:
Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL); non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL),non-HDL-C goal \< 3.36mmol/L (130mg/dL)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 from week 6 to week 12 The percentage of patients achieved LDL-C goal is done in ITT population.
National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:
Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL), non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL), non-HDL-C goal \< 3.36mmol/L (130mg/dL)
Trial Locations
- Locations (1)
Research Site
🇨🇳Tianjin, China