Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia; Dyslipidaemia
Intervention: Rosuvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Keith Ferdinand, Principal Investigator, Affiliation: Heartbeats Life Centre, New Orleans, USA Russell Esterline, Study Director, Affiliation: AstraZeneca
Summary
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.
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Low density lipoproteins cholesterol levels
Secondary outcome: Other blood lipid level changesSafety: adverse events & abnormal laboratory markers
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: March 2002
Last updated: March 13, 2009
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