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

March 19, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

934

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Tianjin, China
        • Research Site
    • Hubei
      • Wuhan, Hubei, China
        • Research Site
    • Hunan
      • Changsha, Hunan, China
        • Research Site
    • Liaoning
      • Shenyang, Liaoning, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Rosuvastatin 5mg qd
Drug: Rosuvastatin
Capsule/Tablet, oral, qd, 6 or 12 weeks
Other Names:
  • Crestor
Experimental: 2
Rosuvastatin 10mg qd
Drug: Rosuvastatin
Capsule/Tablet, oral, qd, 6 or 12 weeks
Other Names:
  • Crestor
Active Comparator: 3
Atorvastatin 10mg qd
Drug: Atorvastatin
Capsule/Tablet, 10mg, oral, qd, 6 weeks
Other Names:
  • Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg
Time Frame: 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.
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
Time Frame: 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.
baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6
Time Frame: 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.
baseline, 6 weeks
Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6
Time Frame: 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.
baseline, 6 weeks
Percentage Change From Baseline in Triglycerides (TG) at Week 6
Time Frame: 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.
baseline, 6 weeks
Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6
Time Frame: 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.
baseline, 6 weeks
Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6
Time Frame: 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.
baseline, 6 weeks
Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6
Time Frame: 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.
baseline, 6 weeks
Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6
Time Frame: 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.
baseline, 6 weeks
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6
Time Frame: 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.
baseline, 6 weeks
Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6
Time Frame: 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.
baseline, 6 weeks
Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6
Time Frame: 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.
baseline, 6 weeks
Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6
Time Frame: 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
6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6
Time Frame: 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
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
Time Frame: 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)
from week 6 to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Marie Eckerd, AZ Pharmaceuticals - US
  • Principal Investigator: Zhao Shuiping, 2nd hospital of Xiangya medical university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 22, 2008

First Posted (Estimate)

May 23, 2008

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D356FC00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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