NCT00185185已完成3 期
Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 主要终点
- Change of intima media thickness of the common carotid artery on the leading side of the neck.
研究概览
简要总结
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean sitting sBP and dBP prior to randomization of 140-180/90-105 mmHg
- •Increased cardiovascular risk, e.g.: a) documented or clinical signs of peripheral atherosclerotic disease stage IIa or lower; b) diabetes mellitus type 2; c) left ventricular hypertrophy on echo; d) current smoking; e) old myocardial infarction, stroke or TIA
- •Intima-media thickness of the common carotid artery greater than or equal to 0.8 and less than or equal to 1.6 mm (measured ultrasonographically) or the plaque volume of the carotid bulb greater than or equal to 4 μl and less than or equal to 500 μl
排除标准
- •Body mass index > 30
- •Any type of known secondary hypertension
- •Electrocardiographic evidence of 2nd or 3rd degree atrioventricular block, atrial fibrillation, cardiac arrhythmia requiring therapy or bradycardia at rest (< 50/min)
- •Obstructive pulmonary disease
- •Claudicatio intermittens
- •History or clinical evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial
- •Hypersensitivity or contraindication to ARBs, Beta-Blockers, HCTZ or any cross allergy
- •Pre-treatment with ARBs or ACE inhibitors within 6 months prior to screening
- •Treatment with disallowed medication
- •Pregnant or breastfeeding females or females of childbearing potential without adequate contraception
- •History of alcohol and/or drug abuse
研究组 & 干预措施
1
Experimental
olmesartan medoxomil
干预措施: olmesartan medoxomil (Drug)
1
Experimental
olmesartan medoxomil
干预措施: Hydrochlorothiazide (Drug)
2
Active Comparator
atenolol
干预措施: atenolol (Drug)
2
Active Comparator
atenolol
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Change of intima media thickness of the common carotid artery on the leading side of the neck.
次要结局
- -Change in plaque volume in the common carotid artery or the carotid bulb.
- -Change of intima media thickness of the common carotid artery.
- -Changes of diastolic and systolic blood pressure.
- -Safety and tolerability
研究者
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