Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
Information source: Abbott
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemias; Hypercholesterolemia; Coronary Heart Disease; Hypertriglyceridemia
Intervention: ABT-143 (Drug); simvastatin (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Abbott Overall contact:
Deb Schuerr, Phone: 847-937-5748, Email: debra.m.scheurr@abbott.com
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 ("bad cholesterol") and triglycerides.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Primary outcome: Percent change in LDL-C with ABT-143 20/135 mg versus simvastatin 40 mgLDL-C
Secondary outcome: Percent change in LDL-C, comparing the following treatment groups in, ranked order:
1. ABT-143 (10/135 mg) versus simvastatin 40 mg
2. ABT-143 (5/135 mg) versus simvastatin 40 mg
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with hypercholesterolemia and hypertriglyceridemia.
Exclusion Criteria:
- Patients with certain chronic or unstable medical conditions.
- Patients receiving coumadin, cyclosporine, or certain other medications.
- Pregnant or lactating women, or women intending to become pregnant.
- Patient with diabetes mellitus that is poorly controlled.
Locations and Contacts
Deb Schuerr, Phone: 847-937-5748, Email: debra.m.scheurr@abbott.com Additional Information
Starting date: December 2008
Last updated: December 19, 2008
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