Status:
COMPLETED
A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia
Lead Sponsor:
AstraZeneca
Conditions:
Hypercholesterolemia
Dyslipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
There are 3 treatment groups in the study: ABT-335 135 mg in combination with rosuvastatin 5 mg, ABT-335 135 mg monotherapy, and rosuvastatin 5 mg monotherapy. The 3 primary outcome measures only comp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT00463606
Start Date
April 1 2007
End Date
February 1 2008
Last Update
October 3 2012
Active Locations (168)
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Site Reference ID/Investigator# 5469
Birmingham, Alabama, United States, 35205
2
Site Reference ID/Investigator# 4428
Birmingham, Alabama, United States, 35209-6802
3
Site Reference ID/Investigator# 4985
Birmingham, Alabama, United States, 35235
4
Site Reference ID/Investigator# 4493
Huntsville, Alabama, United States, 35801