Phase 3
N=1,439
Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood
Dyslipidemia · Coronary Heart Disease · Mixed Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00300482 ↗Enrolled (actual)
1,439
Serious AEs
—
Results posted
Mar 2009
Primary outcome: Primary: Mean Percent Change in Triglycerides From Baseline to Final Visit — -47.1; -42.9; -32.6; -24.4 percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABT-335 (Drug); Rosuvastatin Calcium (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Triglycerides From Baseline to Final Visit |
-47.1; -42.9; -32.6; -24.4; -25.6; -32.1 | <0.001 sig |
| PRIMARY Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit |
20.3; 19.0; 15.0; 8.5; 10.3; 9.3 | <0.001 sig |
| PRIMARY Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit |
-37.2; -38.8; -6.5; -38.0; -45.0; -50.6 | <0.001 sig |
| SECONDARY Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit |
-44.7; -45.3; -18.5; -39.8; -45.8; -51.5 | — |
| SECONDARY Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit |
-55.8; -50.6; -31.9; -41.0; -42.1; -49.1 | — |
| SECONDARY Mean Percent Change in Total Cholesterol From Baseline to Final Visit |
-34.4; -35.7; -13.5; -32.5; -37.3; -42.7 | — |
| SECONDARY Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit |
-39.2; -39.2; -16.2; -34.1; -39.6; -45.0 | — |
| SECONDARY Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit |
-33.8; -40.8; -12.1; -22.9; -29.9; -33.1 | — |
Summary
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.
Eligibility Criteria
Inclusion Criteria
- Patients with mixed dyslipidemia
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 (NCT00300482). 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.