Phase 3
Completed N=310
A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia
Mixed Dyslipidemia
Source: ClinicalTrials.gov NCT00491530 ↗
Enrolled (actual)
310
Serious AEs
11.3%
Results posted
Dec 2009
Primary outcomePrimary: Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study — 94.8; 90.0; 97.7 percentage of participants
Summary
The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study |
94.8; 90.0; 97.7 | — |
| SECONDARY Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study |
-36.9; -29.6; -38.7 | — |
| SECONDARY Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study |
13.7; 11.2; 5.2 | — |
| SECONDARY Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study |
-19.2; -20.2; -20.5 | — |
| SECONDARY Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study |
-26.9; -23.8; -25.1 | — |
| SECONDARY Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study |
-33.7; -18.7; -26.6 | — |
| SECONDARY Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study |
-20.1; -17.9; -20.4 | — |
Eligibility Criteria
Inclusion Criteria
- Adult male and female subjects who voluntarily sign the informed consent.
- Subject has successfully completed the treatment phase of the preceding open-label year 1 study.
Exclusion Criteria
- Subject is using or will use investigational medications, except as approved by Abbott.
- Subject has prematurely discontinued his/her combination therapy administered in the preceding open-label year 1 study.
Data sourced from ClinicalTrials.gov (NCT00491530). 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.