A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Calcium; Calcium, Dietary; Fenofibric acid; Rosuvastatin Calcium

Criteria

Inclusion Criteria

• Adult male and female participants who voluntarily sign the informed consent.

• Fasting lipid results following greater than 12-hour fasting period:

• Triglycerides level greater than or equal to 150 mg/dL,

• High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and

• Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL.

• Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet.

Exclusion Criteria

• Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study.

• Participants receiving coumarin anticoagulants or systemic cyclosporine.