Trials / Completed
CompletedNCT00616772
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
Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects With Type IIb Dyslipidemia With Residual Risk in Addition to Atorvastatin Therapy (FIRST) Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 682 (actual)
- Sponsor
- AbbVie (prior sponsor, Abbott) · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABT-335 | Capsule |
| DRUG | Placebo | Capsule |
| OTHER | Atorvastatin | Capsule |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2012-09-01
- Completion
- 2012-09-01
- First posted
- 2008-02-15
- Last updated
- 2018-07-02
- Results posted
- 2014-01-20
Locations
124 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00616772. Inclusion in this directory is not an endorsement.