NCT00382213已完成3 期
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 主要终点
- ten circulating surrogate markers of atherosclerosis for vascular inflammation.
研究概览
简要总结
The purpose of this study is to determine the efficacy of treatment with olmesartan medoxomil, an Angiotensin Receptor Blocker, compared to placebo on the blood levels of surrogate markers of vascular inflammation for atherosclerotic disease. Patients will be randomized to receive either olmesartan medoxomil or placebo for one year.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or Females age less than or equal to 18
- •TEE-defined Grade III or IV atherosclerotic disease of the thoracic aorta documented within the previous 90 days, or established atherosclerotic disease of the lower extremities as demonstrated by:
- •a history of lower extremity peripheral vascular surgery for obstructive atherosclerotic disease, or
- •a history of lower extremity peripheral arterial angioplasty for obstructive atherosclerotic disease, or
- •a history of lower extremity amputation secondary to atherosclerotic disease, or
- •an ABI <0.90 within the previous 90 days, or
- •a history of claudication in patients with documented coronary artery disease (i.e., history of myocardial infarction, coronary revascularization, or coronary angiography demonstrating at least one obstructive coronary lesion with a 50% or greater stenosis).
排除标准
- •Women of childbearing age who do not agree to utilize protocol approved contraceptive methods.
- •Average pre-dose SBP < 100 or DBP <
- •Patients with any serious disorder including cardiovascular (ventricular arrhythmias, valvular disease or implantable defibrillator), renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic (excluding patients with controlled diabetes mellitus), hematologic/oncologic (including an active malignancy other than basal cell carcinoma or non-metastatic prostate cancer), neurologic, and psychiatric diseases.
- •Patients with a history of MI, PTCA, CABG, heart failure, CVA or TIA within the last 30 days.
结局指标
主要结局
ten circulating surrogate markers of atherosclerosis for vascular inflammation.
and MMP-9.
The surrogate markers of vascular inflammation to be used will include
C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1, IL-6
The primary endpoint for the determination of efficacy will be a composite of
次要结局
- of oxidative stress (GSH/GSSG ratio).
- Composite of adhesion markers (VCAM-1, E-selectin, and ICAM-1).
- Composite of chemoattractant markers (MCP-1, M-CSF).
- Individual circulating surrogate markers of atherosclerosis listed above
- IL-6 and MMP).
- determined by transesophageal echocardiography (TEE) in patients enrolled
- (C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1,
- Composite of Growth Factor Markers (PDGF, HGF, TGF-β).
- Assessment of atherosclerotic disease severity of the thoracic aorta as
- Serum levels of TGF-β, PDGF, HGF, and PAI-1.
- The ratio of reduced to oxidized glutathione in the plasma as an indicator
- on the basis of TEE-defined aortic atherosclerosis.
- Assessment of atherosclerotic disease severity of the peripheral arteries
- of the lower extremities as determined by the ankle brachial index (ABI).
- Endothelial function as determined by brachial artery diameter responses to
- hyperemic flow.
研究者
相似试验
已完成
3 期
Evaluation of the Additional Efficacy, and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential HypertensionEssential HypertensionNCT00872586Daiichi Sankyo304
已完成
3 期
Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential HypertensionEssential HypertensionNCT00856271Daiichi Sankyo287
已完成
3 期
Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential HypertensionHypertensionNCT00591253Takeda413
已完成
3 期
Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe HypertensionHypertensionNCT00185133Daiichi Sankyo1,900
已完成
3 期
Efficacy and Safety Study of Azilsartan Medoxomil Compared to Ramipril for Treating Essential HypertensionHypertensionNCT00760214Takeda885