Status:
COMPLETED
Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
Lead Sponsor:
AstraZeneca
Conditions:
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol (...
Detailed Description
There are 4 treatment groups in the study: ABT-143 capsules 20/135 mg, ABT-143 capsules 10/135 mg, ABT-143 5/135 mg, and simvastatin capsules 40 mg. The primary outcome measure only compares 2 of thes...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participants with hypercholesterolemia and hypertriglyceridemia.
- Participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the Screening Visit(s)):
- Triglycerides level greater than or equal to 150 milligrams/deciliter (mg/dL) and less than 400 milligrams/deciliter, and
- Low-density lipoprotein cholesterol greater than or equal to 160 milligrams/deciliter and less than or equal to 240 milligrams/deciliter.
- Exclusion Criteria
- Participants with certain chronic or unstable medical conditions.
- Participants receiving coumarin anticoagulants, systemic cyclosporins, or certain other medications.
- Pregnant or lactating women, or women intending to become pregnant.
- Participants with diabetes mellitus that is poorly controlled.
- Participant was of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT00812955
Start Date
November 1 2008
End Date
June 1 2009
Last Update
October 3 2012
Active Locations (129)
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1
Site Reference ID/Investigator# 12654
Birmingham, Alabama, United States, 35235
2
Site Reference ID/Investigator# 12634
Columbiana, Alabama, United States, 35051
3
Site Reference ID/Investigator# 12559
Huntsville, Alabama, United States, 35801
4
Site Reference ID/Investigator# 12499
Ozark, Alabama, United States, 36360