NCT00669695终止2 期
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
University Hospital, Grenoble4 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation.
研究概览
简要总结
The aim of this clinical trial is to evaluate the effect of Atorvastatin on the endothelial function improvement during the obstructive sleep apnea syndrome (OSAS) after 3 months of treatment, by a double-blind, randomized, placebo-controlled, multi-center study.
An interim analysis will be performed when 25 patients per group will be included.
详细描述
Secondary objectives of this clinical trial :
- To evaluate the effect of Atorvastatin in comparison with the placebo on the inflammation occurring during OSAS, after 3 months of treatment.
- To evaluate the effect of Atorvastatin in comparison with the placebo on the insulin-resistance associated to OSAS, after 3 months of treatment.
- To evaluate the effect of Atorvastatin in comparison with the placebo on the hypercholesterolemia associated to OSAS, after 3 months of treatment.
- To evaluate at 6 months, the effect of the continuous positive airway pressure (CPAP) + Atorvastatin association on the previously cited parameters, in comparison with Atorvastatin, CPAP and placebo.
- To measure the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo, after 3 months of treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women > 18 years old
- •Subjects diagnosed with OSAS (apnea/hypopnea index = AHI > 30/h)
- •Subjects with clinical ATH from grade I or II controlled with mono-therapy(140<SAP<180 mmHg and 90<DAP<110 mmHg)
排除标准
- •Patients with a history of prior stroke or coronary ischemic disease
- •Chronic respiratory disease (PaO2 < 60 mmHg and/or PaCO2 > 45 mmHg)
- •Lung disease
- •Hypothyroidism
- •Statin treatment
- •Antihypertensive treatment with more than one drug
- •Pregnant or lactating women
- •Alcohol consumption > 3 units/day
- •Treatment by itraconazole, ketoconazole, antiprotease, fibrates, antivitamin K, diltiazem, verapamil, erythromycin, clarithromycin, cyclosporin.
- •Hypersensitivity to one of the drug compounds
- •Patients with modified concomitant treatments during the 3 months before inclusion
- •Potentially dangerous sleepiness
- •Jobs at risk
研究组 & 干预措施
Stat/sham CPAP
Placebo Comparator
Atorvastatin and sham CPAP treatments
干预措施: Atorvastatin treatment (Drug)
Stat/CPAP
Placebo Comparator
Atorvastatin and CPAP treatments
干预措施: Atorvastatin treatment (Drug)
Stat/CPAP
Placebo Comparator
Atorvastatin and CPAP treatments
干预措施: CPAP device (Other)
Stat/sham CPAP
Placebo Comparator
Atorvastatin and sham CPAP treatments
干预措施: sham CPAP treatment (Other)
Placebo/CPAP
Sham Comparator
Placebo and CPAP treatments
干预措施: CPAP device (Other)
Placebo/sham CPAP
Active Comparator
Placebo and sham CPAP treatments
干预措施: sham CPAP treatment (Other)
结局指标
主要结局
The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation.
时间窗: after 3 months of Atorvastatin treatment.
次要结局
- Evaluation of the hypercholesterolemia associated to OSAS.(after 3 months of Atorvastatin or placebo treatment.)
- Evaluation of the effect of continuous positive airway pressure (CPAP) + Atorvastatin association on the previously cited parameters, in comparison with effect of Atorvastatin, CPAP and placebo.(after 6 months of treatments)
- Evaluation of the insulin-resistance associated to OSAS.(after 3 months of Atorvastatin or placebo treatment.)
- Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.(after 3 months of treatment.)
- Evaluation of the inflammation occurring during OSAS.(after 3 months of Atorvastatin or placebo treatment.)
研究者
研究点 (4)
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