Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: rosuvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Pamela MacIntyre, Study Director, Affiliation: AZ Pharmaceuticals - US
Zhao Shuiping, Principal Investigator, Affiliation: 2nd hospital of Xiangya medical university
Overall contact:
Marco Avila, Phone: 86-21-52564555, Email: marco.avila@astrazeneca.com
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: low-density lipoprotein cholesterol (LDL-C)
Secondary outcome: high-density lipoprotein cholesterol (HDL-C),total cholesterol (TC), triglycerides (TG)Apolipoprotein B (ApoB), Apolipoprotein A-I (ApoA-I)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Marco Avila, Phone: 86-21-52564555, Email: marco.avila@astrazeneca.com
Research Site, Beijing, China; Recruiting
Research Site, Shanghai, China; Recruiting
Research Site, Wuhan, Hubei, China; Recruiting
Research Site, Changsha, Hunan, China; Recruiting
Research Site, Shenyang, Liaoning, China; Recruiting
Additional Information
Starting date: May 2008
Ending date: August 2009
Last updated: October 23, 2008
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