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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 682
- 试验地点
- 124
- 主要终点
- Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mixed dyslipidemia
- •Qualifying cIMT thickness
排除标准
- •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
研究组 & 干预措施
ABT-335 + Atorvastatin
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
干预措施: ABT-335 (Drug)
ABT-335 + Atorvastatin
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
干预措施: Atorvastatin (Other)
Placebo + Atorvastatin
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
干预措施: Placebo (Drug)
Placebo + Atorvastatin
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
干预措施: Atorvastatin (Other)
结局指标
主要结局
Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)
时间窗: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
次要结局
- Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)(Baseline, 6 months, 12 months, 18 months, and 24 months)
- Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)(Baseline, 6 months, 12 months, 18 months, and 24 months)
- Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)(Baseline, 6 months, 12 months, 18 months, and 24 months)
- Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)(Baseline, 6 months, 12 months, 18 months, and 24 months)