Phase 3
N=682
Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood
Coronary Artery Disease · Coronary Heart Disease · Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00616772 ↗Enrolled (actual)
682
Serious AEs
18.3%
Results posted
Jan 2014
Primary outcome: Primary: Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT) — -0.006; 0.000 mm/year — p=0.220
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABT-335 (Drug); Placebo (Drug); Atorvastatin (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT) |
-0.006; 0.000 | 0.220 |
| SECONDARY Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT) |
-0.005; -0.003 | 0.813 |
| SECONDARY Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT) |
-0.010; -0.004 | 0.249 |
| SECONDARY Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT) |
-0.014; -0.008 | 0.487 |
| SECONDARY Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT) |
-0.003; -0.019 | 0.112 |
Summary
The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.
Eligibility Criteria
Inclusion Criteria
- Patients with mixed dyslipidemia
- Qualifying cIMT thickness
Exclusion Criteria
- Patients with certain chronic or unstable medical conditions.
- Patients with unstable dose of medications or receiving coumadin, cyclosporine, or certain other medications
- Pregnant or lactating women or women intending to become pregnant
- Patients with diabetes mellitus that is poorly controlled
Data sourced from ClinicalTrials.gov (NCT00616772). 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.