Phase 3
Completed N=650
Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
Dyslipidemia · Heart Failure · Mixed Dyslipidemia
Source: ClinicalTrials.gov NCT00300456 ↗
Enrolled (actual)
650
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: Mean Percent Change in Triglycerides From Baseline to Final Visit — -37.4; -42.7; -31.7; -14.2 percent change — p=<0.001
Summary
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Triglycerides From Baseline to Final Visit |
-37.4; -42.7; -31.7; -14.2; -22.4; -20.2 | <0.001 sig |
| PRIMARY Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit |
17.8; 18.9; 16.2; 7.2; 8.5; 6.8 | <0.001 sig |
| PRIMARY Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit |
-24.0; -25.3; -4.0; -22.4; -31.7; -40.8 | <0.001 sig |
| SECONDARY Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit |
-30.7; -35.0; -17.3; -24.4; -35.9; -40.6 | — |
| SECONDARY Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit |
-38.9; -51.1; -36.9; -19.2; -35.7; -30.0 | — |
| SECONDARY Mean Percent Change in Total Cholesterol From Baseline to Final Visit |
-23.9; -27.1; -12.4; -19.8; -30.0; -33.6 | — |
| SECONDARY Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit |
-29.5; -31.2; -17.6; -22.9; -32.7; -38.9 | — |
| SECONDARY Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit |
-26.8; -32.1; -15.8; -11.4; -14.8; -19.8 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with mixed dyslipidemia
- Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.
Exclusion Criteria
- Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
- Patients who are taking certain medications or unstable dose of specific medications.
- Women who are pregnant or plan on becoming pregnant, or women who are lactating.
Data sourced from ClinicalTrials.gov (NCT00300456). 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. Informational only — not medical advice.