Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

A Randomised, Double-blind Trial to Compare the Efficacy of Rosuvastatin 5 and 10 mg to Atorvastatin 10 mg in the Treatment of High Risk Patients With Hypercholesterolemia Followed by an Open Label Treatment Period With Rosuvastatin Up-titrated to the Maximum Dose of 20 mg for Those Patients Who do Not Achieve Goal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683618
• Other study ID #: D356FC00007
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2008
• Last updated: March 19, 2012
• Start date: May 2008
• Est. completion date: July 2009

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 934
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin
Capsule/Tablet, oral, qd, 6 or 12 weeks
• Atorvastatin
Capsule/Tablet, 10mg, oral, qd, 6 weeks

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Changsha	Hunan
China	Research Site	Shanghai
China	Research Site	Shenyang	Liaoning
China	Research Site	Tianjin
China	Research Site	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg	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.	baseline, 6 weeks	No
Primary	Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg	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.	baseline, 6 weeks	No
Secondary	Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6	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.	baseline, 6 weeks	No
Secondary	Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6	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.	baseline, 6 weeks	No
Secondary	Percentage Change From Baseline in Triglycerides (TG) at Week 6	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.	baseline, 6 weeks	No
Secondary	Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6	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.	baseline, 6 weeks	No
Secondary	Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6	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.	baseline, 6 weeks	No
Secondary	Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6	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.	baseline, 6 weeks	No
Secondary	Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6	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.	baseline, 6 weeks	No
Secondary	Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6	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.	baseline, 6 weeks	No
Secondary	Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6	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.	baseline, 6 weeks	No
Secondary	Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6	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.	baseline, 6 weeks	No
Secondary	Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at 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)	week 6	No
Secondary	6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at 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)	week 6	No
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	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)	from week 6 to week 12	No