NCT00185068已完成4 期
A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 16
- 主要终点
- Change in mean trough seated systolic blood pressure compared to the start of the study
研究概览
简要总结
Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age.
- •Patients with stage II systolic hypertension
- •If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.
排除标准
- •Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.
- •History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
- •Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg).
- •History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.
- •Type I diabetes mellitus.
- •Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
- •Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter.
- •Laboratory test values considered clinically significant by the investigator.
- •Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin > 3 times the upper limit of normal.
- •Pregnant or lactating females.
- •Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.
结局指标
主要结局
Change in mean trough seated systolic blood pressure compared to the start of the study
次要结局
- 1. Blood pressure changes from baseline at the end of each titration period.
- 2. Percentage of patients responding to therapy
- 3. Percentage of patients achieving various blood pressure target goals
研究者
研究点 (16)
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