Phase 3
N=474
Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT00812955 ↗Enrolled (actual)
474
Serious AEs
1.7%
Results posted
Aug 2012
Primary outcome: Primary: Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) — -32.8; -47.2 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABT-143 (Drug); simvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) |
-32.8; -47.2 | — |
| SECONDARY Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) |
-32.8; -46.0 | — |
| SECONDARY Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) |
-32.8; -38.9 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00812955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.