Phase 3
N=542
Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
Dyslipidemias · Coronary Heart Disease · Combined (Atherogenic) Dyslipidemia · Mixed Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00639158 ↗Enrolled (actual)
542
Serious AEs
1.5%
Results posted
Nov 2009
Primary outcome: Primary: Median Percent Change in Triglycerides From Baseline to Final Visit — -57.3; -39.7 Percent change — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABT-335 (Drug); placebo (Drug); atorvastatin (Drug); ezetimibe (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Percent Change in Triglycerides From Baseline to Final Visit |
-57.3; -39.7 | < 0.001 sig |
| PRIMARY Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit |
13.0; 4.2 | < 0.001 sig |
| SECONDARY Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit |
1.8; -1.3 | 0.004 sig |
| SECONDARY Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit |
-57.8; -41.1 | < 0.001 sig |
| SECONDARY Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit |
-42.5; -25.3 | < 0.001 sig |
| SECONDARY Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit |
-55.6; -51.0 | < 0.001 sig |
| SECONDARY Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit |
-49.1; -44.7 | < 0.001 sig |
| SECONDARY Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit |
-52.1; -40.3 | < 0.001 sig |
Summary
The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.
Eligibility Criteria
Inclusion Criteria
- Subjects with mixed dyslipidemia (trigylcerides, > or = to 150 mg/dL to or = to 130 mg/dL).
- Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet.
Exclusion Criteria
- Subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial.
- Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications.
- Women who are pregnant or plan on becoming pregnant, or women who are lactating.
Data sourced from ClinicalTrials.gov (NCT00639158). 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.