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”

This trial is to compare the efficacy,safety and tolerability of rosuvastatin with atorvastatin by assessing the change fof LDL-C in patients with hypercholesterolemia and history of coronary heart disease or risk equivalent, or a 10 year CHD risk of >20%, following 6-week treatment and a possible 6 week extension treatment.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • rosuvastatin 5mg qd
• Experimental: 2
  • rosuvastatin 10mg qd
• Active Comparator: 3
  • atorvastatin 10mg qd

Primary Measures

• low-density lipoprotein cholesterol (LDL-C)
  • Time Frame: -4Weeks, -1 Week, 0 Week, 6 Weeks, 12 Weeks
    Safety Issue?: No

Secondary Measures

• high-density lipoprotein cholesterol (HDL-C),total cholesterol (TC), triglycerides (TG)
  • Time Frame: -4Weeks, -1 Week, 0 Week, 6 Weeks, 12 Weeks
    Safety Issue?: No
• Apolipoprotein B (ApoB), Apolipoprotein A-I (ApoA-I)
  • Time Frame: 0 Week, 6 Weeks, 12 Weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Pamela MacIntyre Study Director AZ Pharmaceuticals - US  

Overall Contact: Marco Avila 86-21-52564555 marco.avila@astrazeneca.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00683618

Study ID Number: D356FC00007

ClinicalTrials.gov Identifier: NCT00683618

Health Authority: China: Ethics Committee