Phase 3
Completed N=2,201
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
Dyslipidemia · Heart Failure · Mixed Dyslipidemia
Source: ClinicalTrials.gov NCT00300430 ↗
Enrolled (actual)
2,201
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study — 83; 86; 85 percentage of participants
Summary
The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study |
83; 86; 85 | — |
| SECONDARY Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study |
-53.0; -47.7; -56.2 | — |
| SECONDARY Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study |
25.2; 25.1; 19.4 | — |
| SECONDARY Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study |
-41.6; -30.2; -38.1 | — |
| SECONDARY Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study |
-48.8; -36.6; -44.3 | — |
| SECONDARY Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study |
-56.9; -37.7; -52.2 | — |
| SECONDARY Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study |
-37.9; -27.5; -35.0 | — |
| SECONDARY Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study |
-44.8; -35.5; -42.9 | — |
| SECONDARY Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study |
-38.87; -27.72; -39.13 | — |
Eligibility Criteria
Inclusion Criteria
- Adult male and female subjects who voluntarily sign the informed consent.
- Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.
Exclusion Criteria
- Subject is using or will use investigational medications, except as approved by Abbott.
- Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.
Data sourced from ClinicalTrials.gov (NCT00300430). 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.