Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)
The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in African American subjects with hypercholesterolemia...
Brief Summary
Official Title: “A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects. (ARIES)”
The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in African American subjects with hypercholesterolemia.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Rosuvastatin
- Drug: Atorvastatin
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Rosuvastatin
- Active Comparator: 2
- Atorvastatin
Outcome Measures for this Clinical Trial
Primary Measures
- Low density lipoproteins cholesterol levels
- Time Frame: 6 weeks
- Time Frame: 6 weeks
Secondary Measures
- Other blood lipid level changes
- Time Frame: 6 weeks
- Time Frame: 6 weeks
- Safety: adverse events & abnormal laboratory markers
- Time Frame: 6 weeks
- Time Frame: 6 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Fasting low density lipoprotein level as defined by the protocol.
- Self described African American race
- Fasting triglyceride level as defined by the protocol.
Exclusion Criteria:
- The use of lipid lowering drugs or dietary supplements after Visit 1.
- Active arterial disease eg Unstable angina, or recent arterial surgery
- Blood lipid levels above the limits defined in the protocol.
- Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
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
Keith Ferdinand Principal Investigator Heartbeats Life Centre, New Orleans, USA
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653744
Study ID Number: 4522US/0002
ClinicalTrials.gov Identifier: NCT00653744
Health Authority: United States: Food and Drug Administration
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00653744
