Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
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
1 other identifier
interventional
934
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2008
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 21, 2008
CompletedFirst Posted
Study publicly available on registry
May 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
March 12, 2012
CompletedMarch 21, 2012
March 1, 2012
1.2 years
May 21, 2008
July 9, 2010
March 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (13)
Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6
baseline, 6 weeks
Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6
baseline, 6 weeks
Percentage Change From Baseline in Triglycerides (TG) at Week 6
baseline, 6 weeks
Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6
baseline, 6 weeks
Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6
baseline, 6 weeks
- +8 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALRosuvastatin 5mg qd
2
EXPERIMENTALRosuvastatin 10mg qd
3
ACTIVE COMPARATORAtorvastatin 10mg qd
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of statin induced myopathy
- Unstable or uncontrolled cardiovascular diseases
- Familial dysbetalipoproteinemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (6)
Research Site
Wuhan, Hubei, China
Research Site
Changsha, Hunan, China
Research Site
Shenyang, Liaoning, China
Research Site
Beijing, China
Research Site
Shanghai, China
Research Site
Tianjin, China
Related Publications (1)
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.
PMID: 28836458DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Marie Eckerd
AZ Pharmaceuticals - US
- PRINCIPAL INVESTIGATOR
Zhao Shuiping
2nd hospital of Xiangya medical university
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2008
First Posted
May 23, 2008
Study Start
May 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
March 21, 2012
Results First Posted
March 12, 2012
Record last verified: 2012-03