Phase 3
N=609
Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
Mixed Dyslipidemia · Coronary Heart Disease · Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00300469 ↗Enrolled (actual)
609
Serious AEs
—
Results posted
Mar 2009
Primary outcome: Primary: Mean Percent Change in Triglycerides From Baseline to Final Visit — -45.6; -42.1; -29.6; -16.5 percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABT-335 (Drug); Atorvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Feb 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Triglycerides From Baseline to Final Visit |
-45.6; -42.1; -29.6; -16.5; -23.2; -30.4 | <0.001 sig |
| PRIMARY Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit |
14.0; 12.6; 19.9; 6.3; 5.3; 6.2 | 0.005 sig |
| PRIMARY Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit |
-33.7; -35.4; -3.4; -37.1; -39.7; -46.0 | <0.001 sig |
| SECONDARY Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit |
-40.8; -42.5; -14.8; -35.7; -41.7; -45.2 | — |
| SECONDARY Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit |
-48.3; -53.5; -36.5; -26.2; -35.6; -38.9 | — |
| SECONDARY Mean Percent Change in Total Cholesterol From Baseline to Final Visit |
-32.8; -34.6; -10.1; -29.6; -33.8; -38.2 | — |
| SECONDARY Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit |
-37.0; -37.1; -12.4; -32.9; -35.3; -40.3 | — |
| SECONDARY Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit |
-26.2; -42.9; -12.4; -29.6; -30.3; -31.9 | — |
Summary
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
Eligibility Criteria
Inclusion Criteria
- Subjects with mixed dyslipidemia
- Subjects must 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 (NCT00300469). 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.