Phase 3
Completed N=758
A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia
Source: ClinicalTrials.gov NCT00463606 ↗Enrolled (actual)
758
Serious AEs
2.2%
Results posted
Aug 2012
Primary outcomePrimary: Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) — 23.0; 12.4 percent change
Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) |
23.0; 12.4 | — |
| PRIMARY Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) |
-40.3; -17.5 | — |
| PRIMARY Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) |
-28.7; -4.1 | — |
| SECONDARY Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set) |
-37.4; -16.0 | — |
| SECONDARY Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set) |
-37.4; -31.8 | — |
| SECONDARY Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set) |
-41.3; -22.2 | — |
| SECONDARY Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set) |
-30.9; -26.4 | — |
| SECONDARY Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set) |
-28.0; -11.4 | — |
| SECONDARY Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set) |
-28.1; -25.0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult male and female participants who voluntarily sign the informed consent.
- Fasting lipid results following greater than 12-hour fasting period:
- Triglycerides level greater than or equal to 150 mg/dL,
- High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and
- Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL.
- Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet.
Exclusion Criteria
- Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study.
- Participants receiving coumarin anticoagulants or systemic cyclosporine.
Data sourced from ClinicalTrials.gov (NCT00463606). 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.