Clinical trial NCT00683618: Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: HMG-CoA
LDL-C
CHD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-23
Enrollment: 934
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg
timeFrame: baseline, 6 weeks
measure: Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg
timeFrame: baseline, 6 weeks
Secondary outcomes:
measure: Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6
timeFrame: baseline, 6 weeks
measure: Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6
timeFrame: baseline, 6 weeks
measure: Percentage Change From Baseline in Triglycerides (TG) at Week 6
timeFrame: baseline, 6 weeks
measure: Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6
timeFrame: baseline, 6 weeks
measure: Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6
timeFrame: baseline, 6 weeks
measure: Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6
timeFrame: baseline, 6 weeks
measure: Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6
timeFrame: baseline, 6 weeks
measure: Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6
timeFrame: baseline, 6 weeks
measure: Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6
timeFrame: baseline, 6 weeks
measure: Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6
timeFrame: baseline, 6 weeks
measure: Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6
timeFrame: week 6
measure: 6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6
timeFrame: week 6
measure: 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
timeFrame: from week 6 to week 12
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Beijing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
Study officials:
affiliation: AZ Pharmaceuticals - US
name: Marie Eckerd
role: STUDY_DIRECTOR
affiliation: 2nd hospital of Xiangya medical university
name: Zhao Shuiping
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao S, Peng D. Efficacy and safety of rosuvastatin versus atorvastatin in high-risk Chinese patients with hypercholesterolemia: a randomized, double-blind, active-controlled study. Curr Med Res Opin. 2018 Feb;34(2):227-235. doi: 10.1080/03007995.2017.1371584. Epub 2017 Sep 18.