Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
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 no less than 10%, following 6-week treatment and a possible 6 week extension treatment...
Brief Summary
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 no less than 10%, following 6-week treatment and a possible 6 week extension treatment.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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
Outcome Measures for this Clinical Trial
Primary Measures
- low-density lipoprotein cholesterol (LDL-C)
- Time Frame: -4Weeks, -1 Week, 0 Week, 6 Weeks, 12 Weeks
Safety Issue?: No
- Time Frame: -4Weeks, -1 Week, 0 Week, 6 Weeks, 12 Weeks
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
- Time Frame: -4Weeks, -1 Week, 0 Week, 6 Weeks, 12 Weeks
- Apolipoprotein B (ApoB), Apolipoprotein A-I (ApoA-I)
- Time Frame: 0 Week, 6 Weeks, 12 Weeks
Safety Issue?: No
- Time Frame: 0 Week, 6 Weeks, 12 Weeks
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Marie Eckerd Study Director AZ Pharmaceuticals - US
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00683618
